Day 1 :
Keynote Forum
David Spaulding
SeerPharma, Australia
Keynote: Reduce your errors through best practice training
Time : 10:35 AM
Biography:
David Spaulding is Senior Consultant and Training Manager for SeerPharma, one of Asia-Pacific’s largest provider of QA/GMP Training and Consulting services to Pharmaceutical and Medical Device Manufacturers. David has worked in various roles within the Pharmaceutical Industry for over 30 years from R&D, Production, Sales and Marketing to CEO of an Australian pharmaceutical company for over 5 years. In his current role, David oversees SeerPharma’s Training Division, including our collaboration with the University of Technology Sydney, to offer Asia-Pacific’s sole Postgraduate course on Good Manufacturing Practice (GMP). David holds an Honours Degree in Chemistry from Monash University and a Diploma in Business Administration from Swinburne University of Technology.
Abstract:
Training is a GMP requirement, but poor training is draining on a business. By understanding stages of learning we can develop training programs tailored to trainee needs to improve the effectiveness of training and its value to the business. Even the best training programs aren’t enough on their own and errors will still occur. Re-training has a place in GMP operations but with a greater understanding of human error, we can apply other initiatives to reduce defects and avoid wasted resources of re-training; a common problem for the industry.
Keynote Forum
Shivraj Dasari
SLS Cell Cure Technologies Private Limited., India
Keynote: Developments in analytical methods (QC) to meet US-FDA & EU requirements for rDNA therapeutic proteins (MAB’s) with special emphasis on the companies & their problems from Asia (India)
Time : 11:00 AM
Biography:
Shivraj Dasari has completed his PhD in Microbiology from Osmania University, Hyderabad, India and has worked in the biotech industry for more than two and a half decades in various Senior Management Positions. He is the Managing Director of SLS Cell Cure Technologies Pvt.Ltd., a start-up organization. It is a rare combination of two rapidly evolving biotech disciplines of in vitro Molecular Diagnostics and Stem Cell & Tissue based technologies. Both these fields have been making rapid strides in terms of technology development and have a special relevance in today’s world besieged with life style diseases. He has published more than 10 papers in reputed journals and has been serving as a Technical Consultant for more than 4 international biotech companies.
Abstract:
The old paradigm of process defines the product is being replaced by analytical methods defining the product. With more and more IND products losing their patents in the coming years, the biosimilar war is only going to hot up more. As more countries put in place a regulatory system to regulate the biosimilars, the requirements for biosimilars for entry into the regulated markets will be very keenly fought by the biosimilar players. The expectations of the regulators namely US, EU and the Asian regulations would be discussed in detail. The expectations of the analytical methods and some of the industrial benchmarks for release benchmarks, etc., will be discussed. Though, the expectations of structural evidence for the active substance (including comparison with reference or natural product), post-translational modifications, conformational data for macromolecules with special reference to recombinant antibodies, immunological characterization, expression of purity, strength, etc., would be discussed in detail.
Keynote Forum
Sunil Kumar Verma
CSIR-Centre for Cellular and Molecular Biology (CCMB), India
Keynote: Horsemeat scandal: A lesson to be learnt from ‘numts’
Time : 11:40 AM
Biography:
Sunil Kumar Verma is an Indian Biologist and, as of January 2015, the Principal Scientist at the Centre for Cellular and Molecular Biology, Hyderabad, India. He is primarily known for his contributions to the development of "universal primer technology" that can identify any bird, fish, reptile or mammal from a tiny biological sample, and satisfy legal evidence requirements in a court of law. This technology has received 12 international patents and it has revitalized the field of wildlife forensics, species identification and DNA based meat adulteration testing and is now going with the name of DNA barcoding across world. He received his DPhil. in Medical Oncology from the University of Oxford, and has received several national awards, including the 2008 CSIR Technology Award, the 2009 NRDC Meritorious Invention Award and the 2009 BioAsia Innovation Award in recognition of his contribution to Indian science and technology.
Abstract:
Previously, the ‘Sushigate’ fish scandal of Florida and now the Europe-wide scandal over the contamination of beef products with horsemeat and, in some cases pork, has thrown the Food Standards Agency into the headlines. The methodology that revealed this scandal is mainly based on DNA barcoding of confiscated beef products involving amplification of small fragment of mitochondrial ‘Cytochrome b’ gene or ‘Cytochrome C Oxidase 1’ gene using universal primers.rnIt has been shown before that the Nuclear Mitochondrial Pseudogenes (numts) can introduce serious ambiguity into DNA barcoding results leading to false detection of many species in one. While amplifying the mitochondrial genomes of Bubalus bubalis (Buffalo) (Genbank Accession No. AF547270.1) and Platanista gangetica (Gangetic dolphin) using a universal primer system, we had detected a specific numt in dolphin DNA, which had high similarity scores with Sus (porcine) mitochondrial DNA rather than that with the dolphin mtDNA sequences available in nr nucleotide database of NCBI, leading to a serious confusion. On the first hand, we also suspected it to be a contamination of pig DNA in dolphin DNA preparations. However, careful re-analysis of the sequences identified this contaminating sequence as a numt, which might have had translocated and integrated to dolphin nuclear genome prior to the divergence of this species from Sus-Bovine lineage. Since the horse (Equus), pig, buffalo and dolphin all belong to Laurasiatheria lineage, the co-amplification of numt could also appear as contamination and adulteration of pig and horse in beef products. This, however, needs to be assessed and taken into consideration while DNA testing is done for food purity testing in particular by the use of DNA barcode system.
Keynote Forum
Peter D. Smith
Parexel International, USA
Keynote: The Importance of Proper Change Management
Time : 12:05 PM
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, Mr. Smith 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. Mr. Smith 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.
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. rnThis 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.
- 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.