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 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.