Day 2 :
Keynote Forum
Per Nilsson
Profox Company, Sweden
Keynote: HACCP and GMP in small food manufacturing companies
Time : 10:00 AM
Biography:
Per Nilsson has a BSc in Environmental and Health Protection from Umea University in Sweden. He has been working with HACCP for more than 25 years and has trained several thousand people in food safety, HACCP and food legislation by traditional learning and workshops. Per Nilsson has written two national guidelines approved by the national authority, about processing meat products and outdoor cooking. He has also been a teacher in food legislation at Swedish University in Agriculture Sciences. Today he is working as a food consultant in his own company and helping companies with their HACCP-plans.
Abstract:
Nearly every food manufacturing companies need a HACCP-plan. It is not only necessary for big companies to have a good HACCP-plan, but also for smaller ones. One problem is that it costs a lot of money to make a proper HACCP-plan and that the small companies do not always have competence for it. It is also important to train companies to understand what HACCP stands for. Therefore I have developed a distance learning course to train companies in the HACCP system. I have also been working to make more simplified models for the HACCP system and still keeping high quality of it. The most important about HACCP is to find out the right hazards and what CCP really are and make it to work every day in the companies. With a lot of paper you need a key for this. I have made a simple and short document to solve this problem. The key is also very helpful when you work both with CCPs and GMP from the hazard analysis. For all people in companies to understand the HACCP-plan it is important to make the plan easy to survey. My experience is that you need to reduce the amount of paper and at the same time keep high food safety. In my newest model the plan is easy to survey and the amount of paper is reduced by 75 %. The results of this are that it has become easier to train small companies to understand HACCP and that they can use the HACCP-plan directly in their daily work.
Keynote Forum
Rama K Pidaparti
Wipro Technologies Limited, USA
Keynote: Compliance and Traceability (CAT) using Regulatory Intelligence (RI)
Time : 10:25 AM
Biography:
Rama K Pidaparti has over 25 years of industry experience. He has a M.S in computer science and Healthcare and Life Sciences courses from Sloan School of Management. He has worked on regulatory compliance aspects from concept to post market, at multiple Life Sciences businesses such as GE Health care, Boston Scientific, Medtronic, Zimmer, Johnson and Johnson, Genzyme, Genentec, Millennium Pharmaceuticals. He is a seasoned speaker on Compliance related topics at Life Sciences events.
Abstract:
Given the increased scrutiny of the agencies and not forgetting the un-announced inspections in Europe, it I imperative to have a good handle on compliance as all compliance risks are business risks. Hence, Compliance and Traceabity for the life sciences industry is the need of the hour, which will create a baseline for what are all the regulations and standards that a business needs to be complying to globally and also manage the new and changing regulations in an ongoing basis. To create the base line the source should be a dependable source of the global regulations and standards (called Regulatory Intelligence). Example of one RI source is Tarius (Denmark based), which will provide what regulations and standards to be complied to globally. Using this source one can create a baseline and monitor for all the changing and new regulations (and standards). This will enable businesses to know and track what needs to be complied to and monitor it. One this is known businesses can also do what is needed to comply and provide traceability to what is done to provide compliance evidence. This entire set up can significantly enhance compliance which will result in having a great control on price of non-compliance.
Keynote Forum
Tanmoy Chakraborty
Manipal University Jaipur, India
Keynote: QSAR study of Benzimidazole Type of Fluconazole Analogues Invoking Quantum Mechanical Density Functional Based Descriptors
Time : 10:50 AM
Biography:
Tanmoy Chakraborty has completed his Ph.D at the age of 28 years from University of Kalyani, West-Bengal. He did his PhD on QSAR / QSPR analysis of Bio-Active molecules invoking DFT based Descriptors. Dr Chakraborty has been carrying his research in domain of Theoretical and Computational Chemistry since last 9 years. Presently he is the Associate Professor, Department of Chemistry, Manipal University Jaipur, Rajasthan and also serving as Deputy Registrar of the University. He has published more than 22 research papers in reputed journals (high impact) and is serving as an International Editorial Board Member of International Journal of Chemo informatics and Chemical Engineering, IGI-Global, USA. Chakraborty is the Editor-In-Chief of Research Book: “Computational Quantum chemistry, Developments and Applications” (Published by Apple Academic Press and Distributed By Taylor & Francis Group. USA.)
Abstract:
Recently Hui-Zhen Zhang et al., reported a series of benzimidazole type of fluconazoles which have potent antimicrobial activity. They synthesized and characterized 27 analogs invoking 1H NMR, 13C NMR, IR, MS and HRMS spectra. An antimicrobial activity of all the newly synthesized compounds has been done in vitro conditions by using two-fold serial dilution technique. The derivative 3, 5-bis (trifluoromethyl) phenyl benzimidazoles exhibits comparable and even stronger antibacterial and antifungal efficiency in comparison with reference drugs such as Chloromycin, Norfloxacin and Fluconazole. In this venture we have tried to make a qualitative correlation between experimental antimicrobial activity and computed Density Functional Theory (DTF) based global quantum mechanical descriptors of instant bio-active compounds. The effect of substitutions on the experimental activities is explained invoking Global Descriptors. Local descriptors have been used to identify site selectivity and mechanistic pathways of bio-active molecules. Finally we have adopted multi linear regression analysis methodology to model the experimental activities of instant organic bio active compounds in terms of DFT based descriptors through Quantitative Structure Activity Relationship / Quantitative Structure Property Relationship (QSAR / QSPR) analysis.
- Track 5: Good Clinical Practices & Good Laboratory PracticesTrack 10: Storage, Distribution, Transportation
Session Introduction
Prakash V Diwan
Anurag Group of institutions, India
Title: Good laboratory Practices:A wake up call for pharmaceutical industries
Biography:
Prakash V Diwan, male Pharmacologist, obtained his PhD from Post Graduate Institute of Medical Education and Research, India in 1980. He served as Assistant Professor in J N Medical College, India and later joined the research and development organization, Indian Institute of Chemical Technology (CSIR) in 1983-2007. He was nominated as the Founder Director, NIPER, Hyderabad in the year 2007. He was awarded with many national awards in the field of pharmacology. He is a Fellow of Royal Society of London (FRSC). To his credit, he has over 200 research publication in national and international journals with an H index 36.00. He has been honoured as a Fellow of Indian Pharmacological Society and Fellow of Andhra Pradesh Academy of Sciences and Fellow of Indian Pharmaceutical association. He has been a Member in Indian Pharmacopeia Commission, Scientific Consultant for various reputed pharmaceutical industries. His contributions are in the field of pharmacology, nanotechnology, clinical researches are laudable. Presently, he holds the responsible positions as Director and Research Scientist in Academia & Research and Development Institutions. He is also a Visiting Scientist at Dr Prabhakar Kore Basic Science Research Center, Belgaum, Karnataka. He has delivered guest lectures and keynote addresses in India and abroad on various challenging areas.
Abstract:
The globe is marching towards perfection. Basically, GLP is a regulation not a guideline. Industry needs greater performance with minimum investments, which is possible only if you adopt GLP. Consumer focuses on and expects quality for a good price. The thalidomide tragedy has opened the new vision for the regulations and has cautioned the world, the extent of toxicity by the drugs. The objective of “Good Laboratory Practice” (GLP) was brought to prevent such a disasters and also poor planning and execution and manipulation of the raw data as manipulation would promote or accelerate approval. GLP aims at: • Securing efforts to generate high quality and reliable data pertaining to protection of man and the environment against various sorts of chemicals and without prejudice against explanation and evaluation of study’s results, • Mutual acceptance of data (MAD) of studies among countries so as to reduce a number of animal tests and trim costs. Good Laboratory Practice (GLP) is a quality system laying down organization, procedures and requirements to plan, implement, document, archive and transfer of non-clinical studies and their results. GLP principles have been developed in the framework of OECD. GLP is the corner stone of the laboratory based activities in any organization. It is not a luxury but essential for the professional laboratories. The GLP assures the quality and integrity and experiments done under GLP are acceptable to countries covered under OECD memberships worldwide. It has the standard operating procedure which is the brain behind the performance which makes it as a system based and not individual based performance. The GLP is a team work consisting of Management, Study Directors, Performer, Quality manager, Archivist and their jobs are well defined. The Study Director is a blue-eyed boy of the management and holds the key of GLP. The management provides resources, Study Director performs and quality assurance units assures the quality and integrity of the study and Archivist preserves the all materials such as study plans, training records, amendments , deviations samples, raw data, etc., in his custody. The documentation is of prime importance. If not documented meaning is not done. There no dearth to prove excellence and meaning well planned is well executed to the satisfaction of sponsor. We need to answer the following: • Do we need GLP? • Can we achieve excellence? • Can we guarantee quality and integrity? • Is it a luxury? • Does it involve risk? • Are there any disadvantages? • GLP is obviously so crucial to modern laboratory operations, but most importantly because good laboratory practice is an essential ingredient for any professional scientist.
Pooja Roy
Vydehi Institute of Medical Sciences and Research Centre, India
Title: Good clinical Practice (GCP) and Declaration of Helsinki
Time : 14:00-14:25
Biography:
Pooja Roy completed her MBBS from Dr B R Ambedkar Medical College, Bangalore and her MD in Pharmacology from Vydehi Institute of Medical Sciences, Bangalore. Currently she is working as an Assistant Professor in Bangalore. She takes active interest in all spheres of the subject and is actively involved in teaching medical students and has several oral papers and poster presentations to her credit.
Abstract:
The concept of ‘good physician’ is evident by the Hippocratic Oath (460 BC). In the United States, the first landmark in the regulation of drugs was the Food and Drugs Act of 1906. In 1947, the Nuremberg Code was created as a result of the unethical and horrific experiments carried out during World War II at Nazi war camps by German physicians. However, since 1964, the Declaration of Helsinki has stood as one of the world’s most authoritative statements on ethical standards for human research. The Declaration has undergone six major revisions, most recently in October, 2008. For many years the USFDA has required that foreign clinical studies supporting applications for drug licensure comply with the Declaration. However, on Oct 27, 2008, the FDA formally discontinued its reliance on the Declaration and substituted the International Conference on Harmonization’s Guideline for Good Clinical Practice (GCP). Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, and monitoring, auditing, recording, analyses and reporting of clinical trials. GCP provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are respected and protected. However, several authors have criticized GCP and compared between GCP and the Declaration of Helsinki from time to time. It has been put forward that at a time when the volume of overseas trials is increasing, the FDA’s new policy is troubling. Several requirements in latest revision of Declaration of Helsinki have been highlighted which are absent in GCP.
- Young Researchers Forum(YRF)
Session Introduction
Mohidurakshan
Sher-I-Kashmir Institute of Medical Sciences, India
Title: Studies on β-CD complexation of a poorly soluble drug
Time : 11:15-11:35
Biography:
Mohidurakshan is working as a Pharmacist in one of the leading tertiary care hospital of Northern India (Sheri-Kashmir Institute of Medical Sciences, Soura Srinagar). She has fifteen years of experience as a Pharmacist in the said organization. She completed Master’s degree in Pharmaceutics from University of Kashmir with distinction and received merit scholarship and a gold medal. She attended conferences and workshops, has a few publications in hand and is a Freelancer for Pharmaliterati.
Abstract:
Clarithromycin is an oral macrolide antibiotic similar to erythromycin and azithromycin. Clarithromycin penetrates lung tissues and macrophages to a greater degree compared to erythromycin. Clarithromycin is a derivative of erythromycin and it has a methoxy group attached to C6 position of erythromycin. This derivatisation makes clarithromycin more stable towards acid than erythromycin. However, the main problem related with clarithromycin is its practical insolubility in water. Moreover, another problem encountered with clarithromycin is that it is a relatively weak UV absorbing compound as it lacks suitable chromophoric group, hence, absorbance measurements will be unreliable. Here in this study β-CD was chosen for the complexation of clarithromycin to increase its solubility characteristics. Preparation of inclusion complexes of clarithromycin was done using kneading, co-solvent evaporation and solvent blend technique in different ratios. Phase solubility and saturation solubility studies of prepared inclusion complexes were done. The phase solubility behavior of clarithromycin in various concentrations of β-CD was obtained. The inclusion complexes were characterized and their drug CD interactions were studied by means of FTIR, UV and SEM analysis. Dissolution study of different formulations was performed using USP type II dissolution apparatus and the drug content was assayed spectrophotometrically in visible range of UV. Both the solubility and dissolution rate of the drug in these formulations was found to be increased. Drug contents were determined by UV spectrophotometry in visible range.
Khalid Bashir Mir
The University of Kashmir, India
Title: Solubility and dissolution rate enhancement of Aceclofenac by solid dispersion technique
Time : 11:35-11:55
Biography:
Khalid Bashir Mir is pursuing his Ph.D. in Novel Drug Delivery Division (NDDD) at Department of Pharmaceutical Sciences, University of kashmir. He has passed his Masters in Pharmaceutical Sciences with distinction and merit scholarship and a gold medal from university of kashmir for being the 1st Rank holder in M.Pharm. He has attended many congresses, seminars, workshops and communicated his research workings.
Abstract:
The aim of this study is to change the solubility of poorly- water soluble, BCS Class-II drug Aceclofenac via SD technique. Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) having both anti-rheumatic, anti-inflammatory and analgesic actions. But, one major problem associated with this drug is its poor solubility in biological fluids, which results into low bioavailability after oral administration. The present objective undertaken was achieved by the formulation of solid dispersions of Aceclofenac with various hydrophilic polymers/carriers (like Urea, Mannitol, PEG-4000 and PEG-6000) in different ratios (like 1:1, 1:2 & 1:3) by solvent evaporation method. The saturation solubility profile of formulated SDs and pure drug was done and 4 formulations like FAC-III, FAC-VI, FAC-IX, FAC-XII, out of total 12 formulations showed good solubility profile and out of these 4 formulations, only FAC-IX ( 1:3 drug:urea) showed highest in-vitro dissolution rate carried out in USP Type II Disssolution Apparatus and maximum drug release of 79.3% within 3 hours study was observed in comparison to 31.2% of drug release within 3 hours from marketed immediate release tablet in phosphate buffer (pH 7.4). The pure drug and formulated SDs were charaterized by FTIR, SEM for drug interaction and surface morphology respectively. The selected formulations were evaluated for drug content, wetting time etc.
Firoj A Tamboli
Bharati Vidyapeeth College of Pharmacy, India
Title: Good manufacturing practice (GMP): An overview
Time : 11:55-12:15
Biography:
Firoj A Tamboli is pursuing PhD in Pharmacy from Shivaji University, Kolhapur. He is working as Assistant Professor at Bharati Vidyapeeth College of Pharmacy, Kolhapur. He has more than 15 years of teaching and research experience. He has published number of papers in reputed national and international journals and has been Member of APTI.
Abstract:
Good Manufacturing Practice (GMP) is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods. The term GMP is recognized worldwide for the control and management of manufacturing and quality control testing of pharmaceutical products. GMPs is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorization or product specification. GMP is concerned with both production and quality control. Both industry and regulatory practices will need to be informed by the best techniques of risk assessment and management. “Pharmaceutical cGMPs for the 21st Century” is intended to jump-start progress into this future. The last few years has seen the FDA steer industry further in the direction of a Quality-by-Design (QbD) approach, and away from the Quality-by-Testing (QbT) approach traditionally taken by the pharmaceuticals sector. This move has largely been lauded by business as a sensible move likely to ensure consistent quality of the end product. Quality objective can be achieved only through careful planning and implementation of QA system and practical implementation of GMP. The effective implementation of GMP requires extensive care and knowledge about the different components of GMP that should be incorporated form the inception of the manufacturing building and product development till the production.
Kalaiyarasi Duraisamy
JNTU Hyderabad, India
Title: A validated UPLC/ESI-MS/MS bioanalytical method for the quantification of Perindopril and Amlodipine in human plasma
Time : 12:15-12:35
Biography:
Kalaiyarasi Duraisamy has completed her M.Pharmacy from The Tamilnadu Dr.MGR Medical University and pursuing part time Ph.D., in JNTU, Hyderabad. She is working in a biopharmaceutical company and having more than 5 years research experience in analytical R&D.
Abstract:
BACKGROUND: In the present study, a validated UPLC/ESI-MS/MS method for the determination of combined dosage form of perindopril and amlodipine in human plasma sample was optimized. This method was responsive and an adequate amount to observe the low-dosage PK studies of perindopril and amlodipine in human plasma. METHODS: Chromatographic separation was achieved on a Waters ACQUITY UPLCTM BEH C18 (100.0 mm X 2.1 mm; 1.7µm) column. UPLC analysis consisted of mobile phase A for 0.1% formic acid in MilliQ water and mobile phase B for 0.1% formic acid in acetonitrile, which was degassed. The gradient elution with flow rate at 0.3 mL min-1 of mobile phase was kept and 10 µL of sample was injected in each run. The total chromatographic run time was 5.5 min. Mass spectrometric detection was carried out in multiple reaction monitoring (MRM) mode using electrospray ion source in positive ion polarity to profile the abundances using the transitions m/z 369 → m/z 172, and m/z 409 → m/z 238 for perindopril and amlodipine respectively and the transitions m/z 612.75 → m/z 280.30 for lercanidipine as internal standard. Argon was used as the collision gas at the pressure of 3.5X10-5 Torr. In this developed method, a high recovery of perindopril and amlodipine in plasma samples was proved with improved quality data in terms of increased detection limits and chromatographic resolution with greater sensitivity. CONCLUSIONS: UPLC with MS/MS has the advantage over problems of poor chromatography, wearisome extraction steps, uncertain characterized peak and high injection load. As per FDA guidelines, the method is validated for its accuracy, robustness and reproducibility. Quantification of perindopril and amlodipine dosage forms by this method is time saving, cost effective and it can be used in clinical studies to quantify the drug content in human plasma samples.
Ibel C Fredy
PES College of Pharmacy, India
Title: Adverse Drug Reaction Reporting – A Retrospective Analysis
Time : 12:35-12:55
Biography:
Ibel C Fredy is doing his VI year Doctor of pharmacy (Pharm D) Intern from PES College of Pharmacy affiliated to Rajiv Gandhi University of Health sciences, Bangalore. He is an active research scholar. He has published over 6 research papers in international journals and been a co-author in several research articles. He is working on other research related activities.
Abstract:
INTRODUCTION: Pharmacovigilance also known as drug safety is defined as the science and activities relating to the collection, detection, assessment, monitoring and prevention of adverse effects or any other drug-related problems. The occurrence of adverse drug reaction is a price that patients have to pay for the benefits produced by modern medicine. METHODOLOGY: The study was a retrospective observational study. Each documented ADRs was assessed for its causality by using the Naranjo’s scale. The severity by modified Hartwig and Siegel scale. Preventability by modified Shamrock and Thornton scale. Results were analyzed using Microsoft Excel RESULTS: Our study showed that gender predominance occurs based on the population included under study and common age groups affected were above 40 yrs. most of the ADR’s was probable, followed possible and less of highly probable and unlikely. Adverse drug reactions reported were commonly moderate followed by mild with a few severe reactions. Majority of the reactions was not preventable followed by probably preventable with only less number of them were definitely preventable. Commonly associated drugs with ADRs were Analgesics, Cephalosporins, followed by chemotherapeutic agents and Quinolones. Retrospective analysis of ADRs reported from 2009-2015 shows significant variations in number of ADRs reported which was maximum during the active pharmacovigilance studies. CONCLUSION: This study strongly suggests that there is greater need for streamlining of hospital based ADR reporting and monitoring system to create awareness, to promote the reporting of ADRs among healthcare professionals and to encourage ADR based studies in hospital which have significant outcome in the ADR reporting.
Khwaja Amtul Raouf Qazi
MRM College of Pharmacy, India
Title: 3G system in pharmacy practice with vigilance
Time : 12:55-13:15
Biography:
Khwaja Amtul Raouf Qazi has completed her MPharmacy (Pharmacology) from Jawaharlal Nehru Technological University, Hyderabad, with a First Class with Distinction.
Abstract:
India is a hub of global clinical trials and a destination for drug discovery & development. However, whether patients in India receive safe drugs or not is still very much in question. Rapid induction of high tech pharma products in the market throw up the challenges of monitoring Adverse Drug Reaction (ADRs). The complete safety data commonly is captured through Pharmacovigilance. True challenge lies in recognizing the importance & applying current 3G system in pharmacy, i.e., Good Manufacturing Practices, Good Laboratory Practices & Good Pharmacy Practices with vigilance in order to improve public health. This article mainly highlights on Medwatch program & its goal and patient safety. It mainly focuses on adverse effect reporting & producing new safety information to patients. Medwatch is the FDA reporting system for an adverse effect, aimed to detect safety hazard signals for medical products. It deals with pre-market review and approval & post-market monitoring for safety. It also determines the benefit and limitation of clinical trials. It focuses on adverse event monitoring and new drug safety problems. Approaches like–Yellow Card Scheme for ADR reporting in the UK should also are encouraged worldwide to identifying new information about hazards associated with medicines. Even, mandatory reporting is required by manufacturer to submit the reports to the healthcare provider & post-authorization safety experience should be conducted to ensure the benefits of use of drugs. Thus, it generates a great way towards a safe medical practice.
Vineela Nekkanti
Rajiv Gandhi University of Health Sciences, India
Title: Challenges in Implementing Good Clinical Practice (GCP) Guidelines and their Mitigations
Biography:
Vineela Nekkanti has completed her Pharm.D at the age of 24 years from Rajiv Gandhi University of Health Sciences, Bengaluru. She was class topper in all the years of Pharm.D and a University Rank holder as well. She did her internship in BGS Global Hospital, Bengaluru and is further interested in pursuing MS in Clinical Research from United States. She has presented four poster presentations at National and International Conferences and published one research article in International Journal. She is also a co-founder of “Care N Share India” Trust, conducting several health related activities for underprivileged people.
Abstract:
Good Clinical Practice (GCP) is a set of guidelines for biomedical research, which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects. It primarily establishes the two main principles i.e. Protection of rights of human subjects and authenticity of biomedical data generated. After the breach of subject rights during human experiments such as Nazi war crime, Human radiation experiments and Thalidomide tragedy, these guidelines came into existence in 1996, which are ubiquitously implemented in clinical research. Though the regulatory bodies maintain stringent norms to implement these guidelines, there are many discrepancies associated with it such as lack of professional training, safety reporting, Informed Consent Document (ICD) administration and record keeping, which thereby depleting the standards of Clinical trials and authenticity of data generated. Hence to overcome such limitations, certain measures have to be taken for the proper conduct of clinical trials.
Bhusnure O G
Channabasweshwar Pharmacy College, India
Title: Zebrafish as a model system for drug target screening and validation
Time : 15:10-15:30
Biography:
Will be updated Soon
Abstract:
From ancient times to today, drug discovery transitioned from serendipity to rationality over its long history. Drugs are a physician’s most powerful weapon to combat disease. The discovery of new drug targets is the basis of new drug development and examination of new drug mechanisms. Proper drug target selection and validation are crucial to the discovery of new drugs. Zebrafish have recently entered the fray as a model animal for some human diseases. The fish are more affordable, easier to keep, and faster to raise than mammals, giving a higher-throughput system. Zebrafish being a non-mammalian, drugs can also be tested for toxicity and their potential therapeutic activity against the target more easily than in mammals. Perhaps, surprisingly, genes that cause disease in zebrafish are similar to those in humans, for example in angiogenesis, inflammation and insulin regulation. Presently, the research using zebrafish is expanding into areas such as pharmacology, clinical research as a disease model and interestingly in drug discovery. The use of zebrafish in pharmaceutical research and discovery and drug development is mainly target screening, target identification, target validation, morpholino oligonucleotide screens, assay development for drug discovery, physiology based drug discovery, Quantitative Structure-Activity Relationship (QSAR) and Structure-Activity Relationships (SAR) study and drug toxicity study. In last few years, the use of zebrafish (Danio rerio) in scientific research is growing very rapidly. Initially, it was popular as a model of vertebrate development because zebrafish embryos are transparent and also develop rapidly. The zebrafish embryo has become an important vertebrate model for assessing drug effects. It is well suited for studies in genetics, embryology, development, and cell biology. Zebrafish embryos exhibit unique characteristics, including ease of maintenance and drug administration, short reproductive cycle, and transparency that permits visual assessment of developing cells and organs. Compounds on various organs, including the heart, brain, intestine, pancreas, cartilage, liver, and kidney, were observed in the transparent animals without complicated processing, demonstrating the efficiency of toxicity assays using zebrafish embryos. The use of animal models allows researchers to investigate disease states in ways which would be inaccessible in a human patient, performing procedures on the non-human animal that imply a level of harm that would not be considered ethical to inflict on a human. Using zebrafish, it is possible to obtain results quickly at lower costs. “Reducing failures early in the development is far more important than filling a pipeline with poorly chosen late-stage products likely to fail, and fail expensively” says Szymkowski.
Varaprasad Adepu
JNTU Kakinada, India
Title: Estimation of Ramelteon in Bulk And Tablet Dosage Form By HPLC
Time : 15:30-15:50
Biography:
I have completed M Pharm and pursuing PhD in JNTU, Kakinada. I has published more than 5 papers in national and international journals and presented more than 4 papers in national, international conferences.
Abstract:
A simple, accurate and precise reverse phase HPLC method was developed, described and validated for the determination of ramelteon in bulk and tablet dosage form. Chromatography was carried on an ODS column using a mixture of acetonitrile and 0.05Mphosphate buffer, pH 6.8 (in the ratio 40:60 v/v) as the mobile phase at a flow rate of 1.2 mL/min with detection at 285 nm by ultraviolet detector i.e. incorporated in HPLC. The retention time of the drug was found to be 7.0 min. The method validation proofs were carried out as per the ICH guidelines. The developed method was validated for linearity over a range of 500µ g/mL to 1500µ g/mL, with a correlation coefficient of 0.999, which shows the method is quite linear. Further precision, ruggedness, accuracy were validated. The %RSD for system precision was observed to be 0.7, whereas the method precision was observed to be 0.5. And for ruggedness the observations were found to be 0.5 and 0.4 respectively. The average recovery of 100.0% indicates the capability of the method, and finally no significant differences in % RSD values w.r.t retention time prove the robustness of the method. As per ICH guidelines, method validation results are in good agreement. The proposed approach is effective and can be applied for the estimation of ramelteon in bulk and tablet dosage form.
Biography:
Kalaiyarasi Duraisamy has completed her M.Pharmacy from The Tamilnadu Dr.MGR Medical University and pursuing part time Ph.D., in JNTU, Hyderabad. She is working in a biopharmaceutical company and having more than 5 years research experience in analytical R&D.
Abstract:
BACKGROUND: In the present study, a validated UPLC/ESI-MS/MS method for the determination of combined dosage form of perindopril and amlodipine in human plasma sample was optimized. This method was responsive and an adequate amount to observe the low-dosage PK studies of perindopril and amlodipine in human plasma. METHODS: Chromatographic separation was achieved on a Waters ACQUITY UPLCTM BEH C18 (100.0 mm X 2.1 mm; 1.7µm) column. UPLC analysis consisted of mobile phase A for 0.1% formic acid in MilliQ water and mobile phase B for 0.1% formic acid in acetonitrile, which was degassed. The gradient elution with flow rate at 0.3 mL min-1 of mobile phase was kept and 10 µL of sample was injected in each run. The total chromatographic run time was 5.5 min. Mass spectrometric detection was carried out in multiple reaction monitoring (MRM) mode using electrospray ion source in positive ion polarity to profile the abundances using the transitions m/z 369 → m/z 172, and m/z 409 → m/z 238 for perindopril and amlodipine respectively and the transitions m/z 612.75 → m/z 280.30 for lercanidipine as internal standard. Argon was used as the collision gas at the pressure of 3.5X10-5 Torr. In this developed method, a high recovery of perindopril and amlodipine in plasma samples was proved with improved quality data in terms of increased detection limits and chromatographic resolution with greater sensitivity. CONCLUSIONS: UPLC with MS/MS has the advantage over problems of poor chromatography, wearisome extraction steps, uncertain characterized peak and high injection load. As per FDA guidelines, the method is validated for its accuracy, robustness and reproducibility. Quantification of perindopril and amlodipine dosage forms by this method is time saving, cost effective and it can be used in clinical studies to quantify the drug content in human plasma samples.
- Workshop
Session Introduction
Ravi Kumar Tummalacharla
Cleanrooms Containments, India
Title: How to prevent outbreaks in endemic countries?
Time : 10:00-11:00
Biography:
Ravi Kumar Tummalachalra is a Graduate Mechanical Engineer. Expert in Design& construction of Bio-Containment projects (BSL-3 Ag, BSL-3, BSL-2 facilities), Cleanrooms, HVAC systems. He has 16 yrs of experience on Cleanrooms, Biocontainment’s, Vivariums (Animal facilities), Eco toxicology labs, Microbiology, Virology, Bacteriology, Analytical, Instrumentation labs. In the past worked for Bharat Biotech, Biovet and Voltas ltd. Founder and CEO of Cleanrooms Containments since 2011. Presented few topics on Bio-Containments, Cleanrooms on various national and international seminars. Exclusively working on Cleanrooms and Bio-Containments. Going to present another talk at IVBWG at Geelong-Australia on Nov 3rd 2015. Member of ABSA (American Biological Safety Association), ASHRAE (American Society for Heating, Refrigeration& Air-Conditioning Engineers), Society for bio-Safety of India, CCSI (Contamination Control Society of India). Actively involved in organizing ASHRAE programs.
Abstract:
The presentation shall give an over view of Bio-Containments, CDC/NIH guidelines, how to select suitable containment, how to stop outbreaks by developing effective, energy efficient, safe new research and manufacturing facilities to prevent outbreaks. Few points on Bio-security also discussed. Presentation shall cover methods and technologies implemented globally for Bio-containments, Research facilities, safety measures to follow while handling infectious organisms. Constructional features of these facilities, some typical layouts, material of construction of these facilities, HVAC requirements, and various primary, secondary and tertiary containment methods are discussed in detail. There are Life science research Bio-containments and Pharmaceutical containments also and both are slightly different. It is explained appropriately. What are the adverse effects of outbreaks, economic loss to nation are also discussed. India is endemic to many infectious diseases. DBT& DST formed some Bio-Safety guidelines for India, but there is a necessity to form a committee to develop and release complete guidelines for the nation. A Govt. certifying body to certify the certifying companies. These companies in turn to certify the bio-containments all over India after construction of new facilities and for re-qualification every year. Bio-containments are for Bio-safety, they are different from Cleanrooms. Major consideration shall be for Personnel and Environmental safety rather than product safety in bio-containment facilities.
- Special Session
Session Introduction
Peter D Smith
Parexel International, USA
Title: The Importance of Proper Change Management
Time : 12:15-13:10
Biography:
Peter D Smith joined PAREXEL (then KMI) in 1994 following a 22-year FDA career and works with clients in the pharmaceutical and biologics industry worldwide. At the FDA, he was an Investigator, specializing in pharmaceutical GMP/GCP and medical device inspections, later serving in FDA Headquarters where he managed the FDA’s Foreign Drug Inspection Program. He has primary expertise in GMP for Active Pharmaceutical Ingredients, sterile and non-sterile dosage forms, management of Pre-Approval Inspections, GMP/Quality Systems and FDA regulatory issues. He holds a BS in Biology from Roger Williams University in Rhode Island. He is a Member of ISPE and PDA, and an Associate Adjunct Professor at the University of Rhode Island, College of Pharmacy.
Abstract:
Change Management in the regulated pharmaceutical, biologic, and medical device industries is a critical element of the Quality System. Changes occur at every phase of product lifecycle from development to product discontinuation. Changes may be critical, such as a manufacturing process change or relatively minor, such as addition of a new sampling port on a process water system. In all cases, all changes must be documented and evaluated for risk and potential impact on product quality. All changes must be evaluated by the Quality Unit and effectiveness checks are required after implementation to ensure the change achieved the intended affect. There must be assurance that no unintended consequence has occurred. Changes must be managed through a robust systematic process in order to assure compliance with regulatory requirements. Virtually all regulators require a change management procedure or program. An integral part of ICH Q10, Pharmaceutical Quality System, is a Change Management System. Regulators including the U.S. FDA and the European Medicines Agency have adopted ICH Q10 to support their GMP regulations. Additionally, the specific GMP requirements enforced by the regulators refer to the control and management of changes. This presentation will expand on the regulatory requirements, expectations by the regulators, discuss common change control program pitfalls, and discuss the elements of a robust change management system. In all cases, all changes must be documented and evaluated for risk and potential impact on product quality. All changes must be evaluated by the Quality Unit and effectiveness checks are required after implementation to ensure the change achieved the intended affect. There must be assurance that no unintended consequence has occurred. Changes must be managed through a robust systematic process in order to assure compliance with regulatory requirements. Virtually all regulators require a change management procedure or program. An integral part of ICH Q10, Pharmaceutical Quality System, is a Change Management System. Regulators including the U.S. FDA and the European Medicines Agency have adopted ICH Q10 to support their GMP regulations. Additionally, the specific GMP requirements enforced by the regulators refer to the control and management of changes. This presentation will expand on the regulatory requirements, expectations by the regulators, discuss common change control program pitfalls, and discuss the elements of a robust change management system.
- Track 1: Good Manufacturing Practices: The Gap withinTrack 2: Current Regulations and Quality StandardsTrack 3: Current GMP Guidelines (cGMP) Track 4: The Role of
Session Introduction
Pradeep K Jha
IIT Kharagpur, India
Title: Entropy in Good Manufacturing Practices driven innovative quality tool for pharmaceutical industry: New paradigm approach for manufacturing excellence and quality standards
Time : 14:00-14:25
Biography:
Pradeep K Jha is a Senior Research Scientist at IIT Kharagpur and Visiting Faculty in JP Business School Meerut. He has completed MSc (Med Chem), MSc (TQM), PhD in Healthcare Management from Gautam Buddha Technical University Lucknow and EUROMA Summer Post-Doctoral Training in Global Operation Management in Hungary. He is Consultant and Member of IcubedG Ideas Pvt. Ltd. and SG ArtHeart Private Limited, respectively. He is Member of WABT France, EUROMA, ISSRF, SAI Professional Societies and Referee of several science and management journals. He has published 15 papers in international journals and presented more than seventy papers at national and international conferences.
Abstract:
It has been customary to implement Good Manufacturing Practices (GMP) in pharmaceutical organizations as a systematic and comprehensive quality approach and sometimes by regulatory enforcement. In this scenario, determination of the obvious entropy/disorder arising during the implementation has not been taken care of yet. Therefore, this paper gives the basis for applying query and visual perception of GMP system driven visualization approach, particularly the Laplace equation, to the determination of disorder and deviation pattern inside the GMP system applied in the organization. In this study, a three-dimensional mesh approached with raw and intermediate input handled under GMP parameter is considered to produce high quality products with minimum entropy by adding the analogy wise different GMP parameters and process variables with Gauss Seidel iteration and thus producing visual picture of the entire system. The approximation involved in applying the concept in sterile drug manufacturing pilot plant. Using numerical technique and computer program, the Gauss Seidel iteration equations have been solved with appropriate GMP parameter and process variable. The result indicates that deviations vary over the GMP compliant system and that the process entropy affects the totality of disorderness. Implementation in GMP complaint drug development pilot plant confirm that the new method provides optimal manufacturing maintaining GMP and high product quality through the visual representation of the entire system and activity to bring into notice the deviations.
Uma Vasireddy
Kakatiya Institute of Pharmaceutical Sciences, India
Title: Comparison of Guidelines of Indian GMP with WHO GMP
Time : 14:25-14:50
Biography:
Uma Vasireddy has completed her M.Pharm from UCPS,Kakatiya University campus and Ph.D. from JNTU Hyderabad in Pharmaceutical Sciences. She is the Principal of Kakatiya Institute of Pharmaceutical Sciences,Kakatiya University and also Honorary Coordinator for Pharmaceuticals Export Promotion Council of India (PHARMEXCIL). She has 30 years of experience in Manufacturing, Clinical Research and also grew to the heights of Vice President in the Abdul Kallam Raju Heart Stent manufacturing division. The highest position held was Dean in Academia and closely associated with several Academic institutions as a guide for Student Research Projects. She presented and attended several national and international conferences. One of her scholastic achievements as a Professor of an Academic Institute is setting up of a Industry Institution Innovation - III Cell, under - DST, Government of India. To her credit, she has more than 50 publications in reputed National and International journals.
Abstract:
Good Manufacturing Practice is a set of principles and procedures for ensuring that pharmaceutical products are consistently produced under controlled conditions to achieve quality standards appropriate to their intended use. India and many countries have formulated guidelines corresponding to their legislative requirements which are governed by regulatory bodies. World Health Organization Good Manufacturing Practices certification is a necessary condition to participate in the international commerce for market authorization. A comparison of guidelines of Indian Good Manufacturing Practices with World Health Organization Good Manufacturing Practices for pharmaceutical products was done. In India under the Drugs and Cosmetics Act, 1940 and Rules 1945 there under prescribes Good Manufacturing Practices under Schedule M and they are to be interpreted with many other conditions laid down under various rules. An elaborate explanation on Schedule M was given which are relevant in the Indian context. Schedule M covers all aspects of production from the raw materials, premises and equipment to the training and personal hygiene of staff. Quality is to be built into each batch of product during all stages of the manufacturing process. Every time a product is made there must be a written procedure and documented proof is essential for each process that could affect the quality of the finished product. On comparison of regulations of Indian Good Manufacturing Practices under the Schedule M and World Health Organization Good Manufacturing Practices it was noticed that Indian Good Manufacturing Practices is found to be more stringent than the World Health Organization Good Manufacturing Practices Guidelines. Compliance and updating of Indian Good Manufacturing Practices will encourage in boosting exports of Indian pharmaceutical Industry by keeping the spirit of ‘Make in India’.
Subhasish Biswas
West Bengal University of Animal Fishery Sciences, India
Title: Applications of Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Point (HACCP) system in hygienic chicken meat production at retail level
Biography:
Will be updated soon
Abstract:
Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Point (HACCP) system are important in order to produce safe food especially for the highly perishable food products like chicken meat. GMP includes many basic operational conditions and procedures like correct construction and layout of the food premises, adequate maintenance of equipments and utensils used in processing, effective pest control program, avoidance of foreign matter within the finished product etc. HACCP is a preventive system assuring the safe production of food products. The application of HACCP is based on technical and scientific principles that assured food safety. The principle of HACCP can be applied to production, meat slaughter and processing, shipping and distribution, food service and in home preparation. In a case study, a comparison has been made between the qualities of chicken produced through the market procedure as it is been practiced with that of chicken produced through intervening certain aspects of GMP and HACCP. The interventions include selection of the healthy birds, cleanliness of the cutting knives and cutting platform, use of potable water and proper disposal of viscera. Fly proof netting and a clean dispensing box for keeping the cards were also installed. The result shows that microbiologically the meats were found more sound and safe when produced with the above interventions in terms of GMP and HACCP, then that of the chicken produced through the market procedure as it is practiced. Personal hygiene of the concern butcher or meat handler was also considered during the course of case study. The work also directed with the study on product processing from both types of meats and the results concluded that the later system of production can reduce more safe and sound products in terms of shelf life and product quality.
Biography:
Abha Doshi is a Principal of MET Institute of Pharmacy, Mumbai, India. She has 20 years of teaching and administrative experience and 3 year of industrial experience in production in Ranbaxy Laboratories Ltd. She has guided many MPharm students and presented research work in various national and international conferences. She has published many research articles in national and international journals.
Abstract:
GMP is referred to as cGMP mostly in United States of America. The ‘c’ stands for current, reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Any company employs cGMP indicates that they are following 21 CFR 210 and 211 and no other. The cGMP regulations for drug contain minimum requirements for the methods, facilities and controls used in manufacturing, processing and packing of drug products. The regulations make sure that a product is safe for use and that it has the ingredient and strength it claims to have. The good manufacturing practices which were considered 10 years ago are not relevant today. Time and process have changed. Industry has to upgrade the GMP level in current context. What is good today may not be relevant after 10 years. Hence, emphasis is on word “current”. GMP has to be updated time to time in order to comply with the standard guidelines. The upgradation of various facilities in manufacturing area with better environment control is required from time to time. In the quality control laboratory, HPLC, GC and other instruments are to be upgraded. As per the current guidelines, we need to have a procedure for backup, restoration and archival of the electronic data inside the instruments. With changing geographies and temperature, i.e., environment conditions across the globe which may be attributed mainly because of the global warming, it is imperative to change the stability conditions, as per the current WHO guidelines, from 25 oC/60% RH to 30 oC/75% or 30 oC/65% in almost all the countries of Asia Pacific and Africa continent.
Aswin Kumar Allupati
Freyr Software Services Pvt. Ltd, India
Title: Clinical Documentation supporting Core Labels for Generics/OTC Products
Time : 15:15-15:40
Biography:
Aswin Kumar is a medical graduate from government medical college in Orissa and has worked for over a decade in various roles of increasing seniority in drug development. He has worked in reputed organizations like RCRS, Accenture and Hospira. He is currently working as Medical Expert at Freyr solutions. In his current role he provides expert advice on the clinical documentation for core labels of OTC/generic products, including the medical review of CCDS and clinical overviews.
Abstract:
The CCDS/CCSI (Company Core Data Sheet / Safety Information) was introduced in 1996 with ICH guideline E2C in the context of PSUR creation and then most significantly further evaluated with CIOMS’ working group on the preparation of CCSI. CCDS/CCSI still remains the cornerstone of the benefit/risk evaluation of the medicinal products. With the advent and practice of Evidence based Medicine (EBM), it is important that the CCDS/CCSI is supported by current best evidence that support the use of drugs/biologics in various approved therapeutic indications. The novel therapeutics are developed based on the unmet medical need and follow the current practices and standards of development. The documentation also follows the current thinking of the health authorities and agencies across the world to receive the approvals. Most companies face major challenge in documentation of CCDS/CCSI for generic/OTC products, which have been in market for many years. It is difficult to track the developmental history and document the scientific rationale for these products as they have been developed in age old times when there was limited regulatory oversight. The scientific information may be limited to understanding the mechanism of action, few in vitro and animal studies. The randomized controlled studies and clinical overviews which form the pivot for any regulatory approval and label creation today are missing from the list of available resources for supporting the CCDS/CCSI documentation for these products. The presentation describes the strategy used by companies to create and update the clinical overviews to support the CCDS/CCSI of generic/OTC products.
Gannu Praveen Kumar
Sahasra Institute of Pharmaceutical Sciences, India
Title: Good manufacturing practices and globalization
Biography:
Gannu Praveen Kumar has been a Professor and, now, is the Principal in Sahasra Institute of Pharmaceutical Sciences since April 2014. He graduated from H K E’s Society College of Pharmacy, Gulbarga University in 1997, completed Post-Graduation from BITS, Pilani in 1999 and PhD from UCPSC, Kakatiya University in 2009. He worked as Assistant Professor for Vaagdevi College of Pharmacy, from 1999-2005, as Associate Professor for SR College of Pharmacy from 2008-2010, as Professor and HOD for Talla Padmavathi College of Pharmacy from 2010-2011 and as Professor & HOD for St. Peter’s Institute of Pharmaceutical Sciences from 2011 to 2014. In 2009, he was appointed as an External Examiner for Post-Graduation and has guided 30 MPharm students. He has published in both national and international journals and compiled few chapters for text books. He received Gem of India Award in the year 1999. He was selected as a Best Academician of Vaagdevi College of Pharmacy in 2002 and of Talla Padmavathi College of Pharmacy in 2011. He is an Advisor for few pharmaceutical companies. He visited foreign countries like London, Dubai, Singapore, Malaysia and Spain as Invited Speaker.
Abstract:
The term globalization was first used in 1940s. The political economist George Modelski reintroduced the term in 1972 to describe the impact of multinational cooperation on economic relations within and between countries. The concept of globalization means that countries and regions of the world come together toward policies and regulations. In other words, it is a global network where there is a better interconnection between different countries and regions. It dismantles the state barriers to trade, economic, social and politics to enhance their growth. Globalization of Good Manufacturing Practices (GMP) helps in removing the trade barriers, improve technical cooperation, improvise cost saving of testing & evaluation processes, support free market competition and information transformation. So, compliance with GMP is a necessary condition for marketing authorization because domestic and foreign producers of pharmaceutical companies cannot sell or market their drugs around the globe. While GMP compliance has not been universally adopted in the developing world, governments in less developed countries are under pressure to comply with GMP requirements when granting marketing authorizations to domestic companies and most of them have developed variety of strategies to ensure that developing countries adopt the rules. GMP requirements require major investment in upgrading manufacturing facilities and this has implications for local producers. An interesting empirical question is the impact of these changes on local markets, access to and affordability of medicines in developing countries. More importantly, pharmaceutical excipients are no longer inert materials but are effective and able to improve the characteristics of the product quality, stability, functionality, safety, solubility and acceptance of patients. Therefore, globalization of medicines supply, also enhance the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. Globalization of the medicine market motivates manufacturers especially in the developed countries to consider various pharmacopeia requirements to facilitate export of their products. In fact, globalization of the finished products supply chain elevated gradually even in the developed countries. Moreover, the current situation needs globalization of the excipients supply chain as well to improve the GMP compliance and appropriately counteract counterfeit and substandard ingredients besides lowering of the pharmaceutical excipients cost in addition to that traceability and contamination control are fundamental elements and should be revised by suppliers. Thus, Globalized Good Manufacturing Practice requirements for pharmaceutical Industries are crucial to face the impact of globalized medicines supply. This study highlights the impact of globalization of good manufacturing practice (GMP) requirements for Pharmaceutical Companies.
Vaishali P Nagulwar
Government College of Pharmacy, India
Title: Quality management systems
Time : 15:55-16:20
Biography:
Vaishali P Nagulwar is currently working as an Assistant Professor (Department of Pharmaceutical Chemistry) in Government College of Pharmacy, Amravati. She has her qualification from Department of Pharmaceutical Sciences; RTM Nagpur University, Nagpur and PhD from Sharad Pawar College of Pharmacy, Nagpur. She has published till date 23 research papers in national and international journals and presented about 35 research papers in various conferences. She is now associated with UG, PG and PhD assignments.
Abstract:
Quality management systems are the integral aspect of Quality Standards required to achieve the goal of providing quality product or service to the society. ANSI/ISO/ASQ Q9001-2000 and ANSI/ISO/ASQ Q9004-2000 describing the guidelines for the requirements and performance improvement, has come up with tremendous change in the scenario of manufacturing as well as in the service sectors. Various modules of Quality basics like Quality benefits, Evolution of Quality, Total Quality Management, Process Management, Quality Tools and Quality Deployment are needed to be understood and followed which can lead to a better managerial control in any organization. Application of these modules results in providing good quality products with maximum profit and minimum loss. Quality as well as safety is now important elements for the customers and hence to gain their faith, trust and goodwill, companies should try to adopt the Quality Management Systems whereby improved products/services and processes will reflect profitability to them for long term. As these quality modules links customers, employees, organizations, suppliers and society together, thus helps in building an improved communications, streamlined work processes, job satisfaction, happier customers, strong customer relationships, economic growth and stability. Customer relationships, continuous improvement and company- wide participation are three important keys of total quality management which works in a fine manner to improve the efficiency and benefits of any organization. Globalization in every sector has now made it mandatory to understand the concepts of quality management systems to every organization if it has to survive in this world of tremendous competition.
Biography:
Abha Doshi is a Principal of MET Institute of Pharmacy, Mumbai, India. She has 20 years of teaching and administrative experience and 3 year of industrial experience in production in Ranbaxy Laboratories Ltd. She has guided many MPharm students and presented research work in various national and international conferences. She has published many research articles in national and international journals.
Abstract:
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. These are the system to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process every time a product is made. Many countries have formulated their own requirements for GMP based on WHO GMP guidelines. GMP is referred to as cGMP mostly in United States of America which refers to current good manufacturing practice. The current GMP guidelines are formulated with continuous improvement and addition in the recent past. These guidelines provide minimum requirement that a pharmaceutical or a food product manufacture must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. These requirements concern methods, equipment or testing which are used for the production, processing, packaging and/or storage of drugs. This ensures that medicine products fulfil the necessary quality criteria. Good quality must be built-in during the manufacturing process; it cannot be tested into the product after wards. Current GMP is designed to ensure that mistakes do not occur again. Systems and equipment which are used to prevent contamination mix ups and error, which may have been top of the line 20 years ago, may be less than adequate by today’s standard. There has to be continuous improvement and updating in the systems, procedures and software’s from time to time by the company. It will be dealt in detail in the talk.
Shashi Kumar Yadav
Sri Indu Institute of Pharmacy, India
Title: Comparison of regulatory requirements for marketing authorization of biologics in United States and European Union
Time : 16:45-17:10
Biography:
Will be updated soon
Abstract:
The aim of the present study was to compare regulatory requirements for the approval of biological products in United States (US) and European Union. USFDA (United States Food and Drug Administration) and EMEA (European Medicines Evaluation Agency) were the regulatory agencies which are responsible for safety regulation of the food and drug products in US and Europe. All biologic medicinal products must be approved by the respective regulatory agency governing the respective market before a particular product can be introduced into the market. The fundamental differences identified during the study between United States and European Union. In US, biologics are regulated as per the Food, Drugs and Cosmetics Act, 1938, and the Public Health Service Act, 1944. The Biologics License Application (BLA) is a request for permission to introduce, for introduction, of a biologic product into interstate commerce (21 CFR 601.2). Quality of biological products in European Union is regulated in accordance with the scientific guidelines issued by Committee for Medicinal Products for Human use (CHMP). Based on our comparison, regulation in all countries are almost similar, however between country to country some differences exist due to regional reasons or language differences. To rectify the difference of the dossier formats, we need to go for harmonizing the dossier format so that we can expect the quality of drug product worldwide. It can be concluded that by practicing the particular dossier requirements, the pharmaceutical companies not only comply regulatory requirement but also provide quality medicine with the needy and sufferers.
Biography:
Neerja S is an MPharm Graduate from JNTU University, and PG Diploma holder in IPR and Regulatory Affairs from NALSAR Law University. She has a vast experience of 11+ years working in various departments (Quality Assurance, Medical Writing, Regulatory Affairs, Site Coordinator for Phase III trial) of leading CROs and pharma companies of India. She is currently associated with Piramal Clinical Research as Head of Quality Assurance. Earlier, she was associated with organizations like Aurobindo Pharma, Dr Reddys, GVK Bio.
Abstract:
It is very usual and common for any pharmaceutical industry to get regulatory inspections may be in manufacturing or in a CRO. Regulatory inspections guide us to make our systems more robust and the presented talk will discuss about: Inspections of majorly two types: (1) Triggered by projects submitted majorly from USFDA, EU/ UKMHRA, WHO, and (2) To assess the system and facility which is been applied for the facility approval to conduct the trials and analysis. For example: ANVISA, MOH Turkey, DCGI. Key problems extracted from various warning letter issued in bio-analytical investigators from where the problems can be anticipated in our labs too. Importance of having corrective and preventive actions so that there are no discrepancies in industrial scenario. For example, Falsified laboratory records with respect to employee time/date records that are inconsistent and/or falsified; Analytical Procedure (AP) raw data sheets; Manipulation of samples - FDA has determined that a firm manipulated test samples in order to meet predetermined acceptance criteria. How we can modulate our routine practice to be prepared for the inspections without any hiccups and last minute rush. Need for maintenance of all calibration and qualification records, access control records, attendance of staff. Any deviations occurred should be addressed properly. Focus on routine activities to bring the system and facility in line to regulatory requirements so that we can bring down the non-compliances drastically. Gap analysis, RACI/ 6 Sigma like tools, Regular IQA and focus on the closure of the same. System department to more focus on SOP, Protocol compliance.
A.K.Pandey
Forest Research Institute, India
Title: Good Collection/harvesting practices of medicinal plants for resource conservation and quality products
Biography:
A.K.Pandey received Ph.D. in chemistry from Lucknow University, Lucknow, India in the year 1986. He is a senior scientist working at chemistry Division of Forest Research Institute, Dehradun, India. His broad research interests are Non Timber Forest Products, medicinal & aromatic plants and biofuels. He has published 90 research papers in various international and national journals of repute. He has attended several international and national conferences on NTFPs, MAPs and biofuel. He is providing senior level consultancy in NWFPs, MAPs and bioduel. He is a member of several professional societies e.g., Society for Promotion of Tropical Biodiversity, Society of Tropical Forestry Scientists and Medicinal and Aromatic Plants Association of India. He is in the editorial boards of various national and international journals viz. Journal of Biofuels, Indian Forester, Journal of Tropical Forestry, Indian Journal of Tropical Biodiversity, Pharmacgnosy Magazine and World Applied Sciences Journal etc.
Abstract:
India has a long tradition of use on herbal medicines and has very rich diversity of medicinal plants. The increasing demand for herbal products has forced the overexploitation and unscientific collection of natural populations of medicinal plants from the forests rendering several species to vulnerable state. Any threat to these valuable resources will not only jeopardize the health of millions of people, but will also affect the livelihoods of resource poor collectors/farmers and communities that depend on them. Since the medicinal plants and their plant parts are used in raw form in the traditional medicines, the important aspects which govern the quality of the drug at initial level are the correct identification of species, optimum stage of harvest and primary processing. This paper gives a brief account on Good collection/harvesting practices of some important medicinal plants like i.e., Aonla (Phyllanthus emblica), Baividang (Embelia tsjeriam-cottam), Baheda (Terminalia bellerica), Gudmar (Gymnema sylvestre), Sarpagandha (Rauvolfia serpentina) and Kalmegh (Andrographis paniculata). Adoption of sustainable harvesting practices at right time of harvest showed positive impact on resource conservation, socio-economic status of community, quality of produce, economic returns and marketing. It is evident from our study that the medicinal plants collected at right time of maturity following sustainable harvesting practices possess better quality in terms of active ingredients concentration. Sustainable harvesting technologies have been standardized for only few species, which are used for large-scale production of phyto-pharmaceuticals. But there is an urgent need to develop suitable technologies for other important plants used for the manufacture of drugs. The technique should be simple which could be easily understood and adopted by the collectors. This will help in avoiding indiscriminate extraction of plant, supply of good quality material to the consumer and enabling the collector in getting a better price of the produce. Sustainable harvest system and effective community managed regulatory mechanism shall be put in place for harvesting of medicinal plants from the wild.
- Track 6:Quality ControlTrack 7:Quality AssuranceTrack 8:ValidationTrack 9:Contract & Sterile/Aseptic ManufacturingTrack 11:Formulation DevelopmentTrack 12:GMP in Food IndustryTrack 13:GMP in Microbiology and Biotechnology
Session Introduction
R Manavalan
Annamalai University, India
Title: Food safety management systems-requirements for any organisation in the food chain (ISO 22000:2005)
Time : 11:45-12:10
Biography:
R Manavalan has completed PhD from Birla Institute of Technology & Science, Pilani, India. He is the “UGC BSR Faculty Fellow” at the Department of Pharmacy, Annamalai University to coordinate research at PG & PhD levels. He has published 120 papers in reputed journals.
Abstract:
Food safety is related to the presence of food–borne hazards at the point of consumption. Introduction of food safety hazards can occur at any stage of the food chain and hence adequate control throughout the food chain is essential. The food safety is ensured through the combined efforts of all the parties in the food chain organisations within the food chain range from feed producers and primary producers through food manufacturers, transport and storage operators and subcontractors to detail and food service outlets and service providers. The international standard ISO 22000:2005 specifies for a food safety management system recognised the following key elements to ensure food safety along the food chain namely interactive communication, system management, Prerequisite Programmes (PRPs), Hazard Analysis Critical Control Point Principles (HACCP). Effective food management system is established, operated and updated and incorporated into the overall management activities of the organisation. The international standard integrates the principles of hazard analysis and application steps developed by the Codex Alimentarius Commission. By means of auditable standards it combines HACCP plan with Prerequisite Programme (PRPs). During hazard analysis, the organisation ensures hazard control by combining PRP(s), operational PRP(s) and HACCP plan. Obtaining ISO 22000:2005 Certificate ensures safety food to the consumers.
Arunadevi S Birajdar
K T Patil College of Pharmacy, India
Title: HPLC method development and validation as per ICH guidelines
Time : 12:10-12:35
Biography:
Arunadevi S Birajdar has completed her PhD from Dr M G R Medical University, Chennai. She is working as Associate Professor in K T Patil College of Pharmacy, Osmanabad, Maharashtra, India. She has published more than 10 papers in reputed journals and is serving as Editorial Board Member of national and Reviewer of international journals. She is the Life Member of Indian Pharmaceutical Association as well All India Pharmacy Teachers Association, (IPA & APTI). She is having around 22 years of Experience in Pharmacy Education 12 years Administration as well as 10 years teaching at Diploma, UG and PG level.
Abstract:
Method development for rapid analysis in pharma industry is very important aspect for standardization of crude drug and maintains quality of in-process and finished products as per official standards. It is challenging job to the people working in QA-QC Department that to develop the new method which will easy, take short time for analysis (non-tedious) and economical. In this topic, we will discuss about basic idea of method developments and trouble shooting or problems regarding newly method development with same procedures while performing. Now-a-days, we are using more sophisticated instruments for method development as UV-Spectophotometry, HPLC, HPTLC, AAS, for quantitative analysis. I am going to highlight on some of the method developments.
Charmy S Kothari
Nirma University, India
Title: Identification of biomarker(s) from polyherbal formulation used in hyperlipidemia for qualitative and quantitative analysis
Time : 12:35-13:00
Biography:
Charmy S Kothari has 11 years of teaching and research experience. She published 18 researches papers. Three research presentation awards. Additionally, she is the recipient of Dr P D Sethi’s Research Paper Certificate of Merit Award 2007. She received a financial assistance from GUJCOST worth Rs. 40,000 to organize workshop on Process Spectroscopy & Chromatography. She received a Minor Research Grants from Nirma University worth Rs. 90,000 and GUJCOST worth Rs. 5,00,000. Her areas of research interest are analytical and bioanalytical method development by QBD approach, validation and stability studies, impurity profiling and Isolation, identification and characterization of marker compounds from plants and formulations.
Abstract:
Herbal medicines have a long therapeutics history and are still serving the need. However, the quality control of herbal medicines still remain a challenge because of the complex nature of the phytoconstituents. The aim and objective of the study is identification of biomarker for qualitative and quantitative analysis of polyherbal formulation containing Arjuna, Guggul & Pushkarmoola in combined dosage form. The poly herbal formulation was evaluated for physical parameters, organoleptic parameters and physicochemical parameters as per AYUSH and WHO guidelines. Quantification of constituent was done by developing and validating High Performance Thin Layer Chromatography (HPTLC). The HPTLC method was developed and validated for poly herbal formulation in the methanol extract. HPTLC separation was achieved on precoated silica gel 60F-254 using Toluene : Ethyl Acetate (8:2 v/v) as mobile phase. Polyherbal formulation methanolic extract gave the peak of E and Z guggulsterones at Rf value 0.34 and 0.41, respectively. Which was further confirmed with reference standard. Assay % of E and Z guggulsterones was found to be 81% and 83%, respectively. Spots of E and Z guggulsterones from polyherbal formulation was isolated for identification. Identification was confirmed by mass spectrometry. Hence, E and Z guggulsterones can be used as a biomarker controlling quality of polyherbal formulation containing Arjuna, Guggul & Pushkarmoola in combined dosage form.
Kandra Prameela
GITAM University, India
Title: Almighty Astaxanthin: Over view on nutraceutical based approach to aim to combat cancer
Time : 13:40-14:05
Biography:
K. Prameela completed her Ph.D from Andhra University in Biochemistry. She is working as an Assistant Professor in Department of Biotechnology, GIT, GITAM University. She has published more than 12 papers in reputed national and international journals. She has been awarded with young scientist fellowship.
Abstract:
Nutraceuticals are a part of dietary prospect that play key role to improve health and reduce various diseases. Globally cancer is the second leading cause of death. Astaxanthin is a natural nutraceutical found in sockeye salmon, lobster, shrimp, crawfish, crabs and salmon roe, etc. It is a xanthophylls red color carotenoid responsible for red pigmentation in animals. It provides a wide range of applications in medicinal, agricultural, pharmaceutical, nutraceutical and cosmetic industries owing to their consumed acceptance of commercial products. The Food and Drug Administration of the United States has permitted to extensively use as feed additives for fish, lobsters, shrimp and chickens. However natural antioxidants are promising compounds to human metabolites which can facilitate the studies on identification of mechanism in reduction of toxicities due to free radicals in many degenerative diseases. Furthermore, the antioxidant activity of astaxanthin is 10 times more than β-carotene and 100 times more than α-tocopherol. It also been shown to boost immune system, improves reproductive health, regulates blood pressure, prevent chronic diseases like Alzheimers’s and Parkinson’s, controls prostate problems, suppress tumor growth, attenuates metastasis and inhibits key enzymes in cancer. Therefore, astaxanthin is most effective nutraceutical compound which react rapidly with free radicals that can minimize toxicity. Hence, developments in nutraceuticals have provided new tools in cancer therapy.
G.Sundar
PharmQA Compliance Services, India
Title: Effective GMP AUDITS for APIs and Formulation Pharma Companies
Time : 14:05-14:30
Biography:
G.Sundar has completed his Msc Chemistry at the age of 22 years from Annamali University and qualified as GxP compliance person with 22 years of rich experience.. He is the director of PharQa complaince services, a premier GxP consulatntcy service organization. He has published more than 20 papers in reputed journals and has been serving as an editorial board member of repute.
Abstract:
The independent third-party GMP audit is to evaluate GMP compliance status of the manufacturer in accordance with the current GMP requirements set forth in 21 CFR Part 210 & 211 ICH Q7 and EU GMP with its interpretations. The compliance status will be evaluated in terms of Quality compliance with respect to all the six systems and hardware, software, and personnel. All deficiencies identified during the cGMP audits will be noted in the audit report with gap analysis and proposed corrective actions. A pharmaceutical auditing plan may include CAPA on: • Documentation and Record Control Verification of data integrity and its control measures • Manufacturing Process and Equipment • Training • Validation and Qualification While the purpose of all audits is the same, the elements and steps involved in the audit process may differ depending on the type of audit required and its applied regulation standards. Any pharmaceutical manufacturing company must be able to prove that it does so with absolute reliability, under optimal secure conditions, and with extreme uniformity to allow for exact reproduction. Therefore, all manufacturing equipment and processes must be qualified and validated to ensure performance.
Sheelpriya Ratnakar Walde
Gurunanak College of Pharmacy, India
Title: Pharmaceutical process validation: A tool for pharmaceutical compliance monitor
Time : 14:30-14:55
Biography:
Will be updated soon
Abstract:
The process validation is applicable to any aspect of operation that may affect the quality of the pharmaceutical product either directly or indirectly. The primary goal of the validation process in the pharmaceutical industry is to have documented proof that quality is part of each and every step of the manufacturing and distribution system, instead of merely testing products at the end of the process. Quality cannot be ensured by sampling, testing, release of materials and products. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. Process validation of a process will ensure production of drug of reproducible quality. This presentation explores the concept of pharmaceutical process validation in monitoring the various in process variable which help in assuring the quality of pharmaceutical formulation.
Y Padmavathi
G. Pulla Reddy College of Pharmacy, India
Title: Quality control analytical methods - Switch from HPLC to UPLC
Time : 14:55-15:20
Biography:
Y Padmavathi is working as professor and HOD, Department Pharmaceutical Analysis and quality assurance, at G. Pulla Reddy College of Pharmacy, Mehdipatnam, Hyderabad. Her graduation and post-graduation is from Andhra University and completed her PhD from Osmania University. She has 20 years of experience in teaching and guided about 50 M.Pharm students. She has published more than 20 papers in national and international journals. She is editorial board member of reputed national journals. She is life member of IPA and APTI.
Abstract:
Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. More exacting and sophisticated analytical methods are being developed for their evaluation of new drug substances and drug products. HPLC play an important and critical role as a quality control analytical method for qualitative and quantitative analysis in pharmaceutical industries. Moreover, the importance of HPLC uses in these fields falls under the stringent regulations established by the U.S. Food and Drug Administration (FDA). This obligates all pharmaceutical companies to detect the quality of their products by using the HPLC before allowing them to sell it in the global market. Ultra-high performance liquid chromatography (UPLC) has marked revolution by opening new ways for analyst to fetch rapid analytical separation techniques without sacrificing high-quality results obtained earlier by high performance liquid chromatography (HPLC). Innovations in column technology led to evolution of UPLC technology which enables the use of sub-2-μm particle columns, which results in lower flow rates and shorter run times. UPLC methods provide a marked reduction in analysis time, improved resolution, and reduced mobile phase consumption. Methods that run on modern chromatographic systems improve laboratory efficiency and productivity, as well as reducing costs for manufacturing facilities. UPLC technology results in the full benefits of higher throughput, lower costs, and faster time to market for routine analysis of generic drugs.
B Nagarani
SriKurpa Institute of Pharmaceutical Sciences, India
Title: Will be updated soon
Time : 15:20-15:45
Biography:
B Nagarani has completed her MPharmacy from Osmania University and is working as Assistant Professor in Srikrupa Institute of Pharmaceutical Sciences. She has published more than 8 papers in national and international journals.
Abstract:
Will be updated soon
Dharmvir Uppal
GNA University, India
Title: Effects of Lean Manufacturing practices to encourage continuous improvement for Manufacturing Excellence
Time : 15:45-16:10
Biography:
Dharmvir Uppal Doctorate in lean manufacturing from ISBM and MBA in operation management having 19 years’ experience in the field of gear industry, current and future state mapping, cellular manufacturing, SMED, TQM, TPM, 5S, Six Sigma, Kanban, JIT, Autonomous, preventive maintenance and single piece flow system, having 6 year experience as a project coordinator and beside this having three year experience as an Assistant professor. Achievements- 1) More than 103 projects and improvements have been completed till date. 2) Runner up in improvement activities in 2007 3) Star performer in 2008 4) Leader of best 5S team in 2010 and 2011 5) Successfully clear FMC USA audit in 2013 6) Member in CICU Ludhiana
Abstract:
New paradigm approach for manufacturing excellence and quality standards will enhance the links among industry players, patients and providers. In many industries, particularly the pharmaceuticals industry, the tight regulatory necessities and the challenges of staying competitive in a fast-changing environment are not only increasing the stress on sales, output and organize the different production functions, but also on quality inspection/assurance sections. The QA persons are now working to keep control of good quality, costing, durability and speed, while also complying with regulations. If this is to be achieved, quality assurance must become a proactive process which ensures that product manufacture adheres to specific standards and strives to continuously improve results and eliminate errors. In a nutshell, products should be “fit for purpose” and “first time right”. By improving process confidence and efficiency, quality guarantee can bring about prompt and constructive operational performance which still observes all requirements from statuary point of view. To make sure the stability of this achievement over the medium to long stretch, quality confirmation also required to follow quality improvement initiatives, abolish pursuit which do not give value addition, minimize the process time need to maintain and resolve quality issues, and lessen reappearance of deviations. A holistic approach of QA process optimization and organization can generate a quality culture across a pharmaceutical organization and help to overcome coming challenges. The main reason for optimization of process is to focus on value adding activities so that value and responsiveness to the customer are maximized and waste, delays are eliminated. Lean practices should be applied in an organization’s structure and processes to encourage continuous improvement.
Raja Chakaverty
Bengal College of Pharmaceutical Sciences & Research, India
Title: Quality control methodologies for standardization of herbal medicines: An assessment
Time : 16:10-16:35
Biography:
Raja Chakraverty is an MPharm in Pharmacology and is currently working in the designation of Assistant Professor in the Department of Pharmacy at Bengal College of Pharmaceutical Sciences and Research, Durgapur with a teaching experience of two years in BPharm and MPharm classes under West Bengal University of Technology. He has also published more than 15 scientific papers in indexed journals and has been serving as an Editorial Board Member of a number of reputed journals. He has also been awarded with the ‘Best Paper Award’ at the poster session of four national level conferences and symposia.
Abstract:
In this presentation, the focus will be on systematically discussing the methods adopted and their application in quality control and standardization of herbal drugs. For this purpose a comprehensive literature review was performed on recent articles related to the core theme of the presentation from the current bibliographic, abstracting and indexing services including PubMed. It is a fact that herbal medicines of a kind planted or in the wild usually differ from each other greatly based on their storage under different environmental conditions. Even the quality parameters of the same batch of herbal medicine may vary significantly. Therefore, it is of utmost significance to ensure the quality of herbal medicines through effective and convenient analytical methods. The quality control of herbal medicines generally involves three steps. The first is false and true identification, the second is to distinguish originating regions of herbs, and the third is quality evaluation. The false and true identification aims to distinguish the species by means of many qualitative analytical methods. The qualities of herbs are closely related to their producing areas. For this reason, the determination of producing regions is critical. The quality of herbs depends on the environments, collecting time of these products and the storage conditions. The quality control analytical techniques have undergone a paradigm shift of sorts since in the recent years transcending from the typical estimates from the morphology, microscopic feature identifications to the physical and chemical properties based on the major constituent identification to almost all components being identification based on utilization of the fingerprint spectra and allied chromatographic techniques.