Speakers Presentation

The 2-day long Workshop on Quality – Good Manufacturing Practices for 21st Century, was organized in Mumbai on February 20th & 21st, 2008, by Indian Pharmaceutical Association (IPA), in collaboration with American Association of Pharmaceutical Scientists (AAPS) & International Pharmaceutical Federation (FIP). The theme of the workshop was Linking Process Understanding to Good Manufacturing Practices. The workshop was aimed at exposing the professionals from the Indian Pharma industry & academia to the concepts of ‘Quality by Design’ & Process Analytical Technology (PAT), the key initiatives of ICH Q8, Q9 & Q10 guidelines. In his opening remarks, the Honorary General Secretary of IPA, Mr. S.D. Joag gave the participants an outline of the sessions lined up in the workshop. Dr. Vinod Shah, Scientific Secretary of FIP, in his welcome address gave the delegates an outline of the organizational structure of FIP & its various initiatives in the area of promoting pharmaceutical sciences. Mr. Prafull Sheth, Immediate Past President of IPA & current Vice-President of FIP, delivered the keynote address for the day.In his address, Mr. Sheth emphasized that this workshop was part of the MoU signed by IPA with AAPS, FIP, Academy of Pharmaceutical Science & Technology of Japan (APSTJ) & forum for Pharmaceutical Technology Innovation (FPTI) in 2003, for conducting collaborative international tutorials and educational workshops in India in the area of pharmaceutical technology and cutting – edge science. Mr. Prafull Sheth appreciated the efforts of Dr. Vinod Shah, Mr. Ajit Singh & Mr. Subodh Priolkar towards development of this relationship & acknowledged the hard work put in by the organizing team in assembling the program. Session 1 of the program dealt with the key philosophy of ‘Quality by Design’ & was chaired by Dr. Vinod Shah. Dr. Tom Sam, Head of the Industry Pharmacy Section of FIP & Director, Global Regulatory Affairs, Organon, in his talks exhorted on the Quality mantra “Quality cannot be tested into products; it has to be built in by design” & how the entire process begins with adequately defining the target product profile. Dr. Mukund Yelvigi, Director, Therapeutic Area Management, Wyeth Research, USA , explained the concepts of Design Space, Control Space & Quality Risk Assessment Tools like Risk Prioritization Matrix towards identifying the critical quality attributes & process parameters in a typical manufacturing process. Dr. Yelvigi took up case study of scale-up & manufacture of extended release tablets to drive home his point. Mr. Satish Rajkondawar, Vice-President, Sanofi – Aventis  (I) Ltd. presented the Indian perspective of ‘Quality by Design’ with the help of suitable examples. Session 2 on PAT & Risk Management, was chaired by Mr. Devinder Pal, Head, Catalyst Pharma Consulting Group. Speaking in this session, Dr. Tom Sam explained the basic tenets of Quality Risk Management & the formal risk management tools available for use. Dr. Mukund Yelvigi discussed the various PAT tools & explained use of these n process development & product manufacturing cycle. Mr. Gopal Nair, CEO, Grasp Enterprises, made an interesting presentation on applicability of PAT to pharmaceutical manufacturing in India & the challenges involved in integrating it into drug discovery, development & manufacture cycles. Dr. Prakash Mody, Managing Director, Unichem Laboratories, India , delivered the keynote address on Day 2. Dr. Mody, very aptly opined that India of the 21st Century, exhibits challenges for the quality professionals with matching huge market opportunities. The new age mantra according to Dr. Mody was ‘Quality Pays’ & not ‘Quality Costs’. Session 3 of the program focused on the theoretical & practical aspects of cGMPs & cGLPs. Speaking in this session, Mr. Mike Anisfeld, Senior Consultant specializing in GMP / Quality activities for the healthcare manufacturing industries, elaborated on the GMP fundamentals, key GMP drivers & the advantages of complying with cGMPs vis-à-vis ISO 9000. In his talk on “Dealing with Regulatory GLP & GMP Issues / Inspections”, Mr. Anisfeld, highlighted the importance of strategic, long-term & short-term planning in tackling inspections by various regulatory agencies like US FDA & EU authorities. Mr. Anisfeld further advised on the contributors to failures / deviations in any manufacturing process & the corrective & preventive actions (CAPA) recommended as per 21CFR820.100. His talk was followed by a presentation by Mr. Rajeev Patil, Vice President, Regulatory Affairs, Lupin Ltd. Mr. Patil discussed the emerging generic market dynamics in the US & EU & the challenges Indian generic companies face in adapting to these. Mr. Prafull Sheth was the Chairperson for this session. The regulatory perspectives were deliberated on in the Session 4 of the program. Dr. Abdel Aziz Saleh, Special Advisor to the Regional Director, WHO/EMRO, delivered the first talk in this session. Dr. Saleh apprised the delegates about the WHO/GMP guidelines for pharmaceutical products. Dr. Milind Joshi, President, Global Regulatory Management, J. B. Chemicals & Pharmaceuticals Ltd. made a presentation on “GMP for 21st Century : Indian Regulatory Perspective”. Dr. Saleh again continued on the WHO Pre-Qualification Program – its administrative & organizational structure & functioning. This session was chaired by Dr. Muku