ISPE And PIC/S Co-Sponsor Premiere Interactive Workshop
Thirty five countries were represented, with 161 industry participants and 65 regulatory participants attending, "Systems Approach to Quality Risk Management" 22-23 November 2007.
At the occasion, a one--day, hands-on workshop was an opportunity for industry professionals and GMP inspectorate leaders to make a difference, and offered attendees the chance to work side-by-side with regulators, with the goal of creating a better understanding and working relationship between regulators GMP inspectors and industry, and will result in further joint workshops in the future.
"This was a wonderful opportunity for all of the inspectors to come together to talk about ways to move forward in the future," said Jacques Morénas, Chairman of PIC/S and Assistant Director of the French Agency for the Safety of Health Products. "It was one of the best-attended events we have ever presented and we were able to move from concepts to practical applications. I was very happy with the outcome."
During the one day dedicated to industry, the Workshop provided updates on ICH Q8, Q9 & Q10, as well as the risk management methodologies the industry can use to enhance manufacturing efficiencies. During the second day, dedicated for both industry and GMP inspectors, examples of the use of risk management approaches, in the form of actual case studies, were presented by a French GMP inspector and an industry representative.
Inspectors and industry representatives also worked together in small breakout groups to discuss and seek solutions to two fictitious manufacturing problems using risk management tools and methodology. These workshop exercises revealed that GMP inspectors and industry generally reached the same conclusions on how to solve manufacturing problems, using similar risk management approaches.
There was enthusiastic participation and interaction between GMP inspectors and industry, not only during the Workshop sessions but also during the less formal coffee and lunch breaks and evening networking reception.
"We in ISPE were proud to have been the first industry organization to be invited to co-host such a prestigious event in such a dynamic part of the world and, as Chairman, I was delighted to be able to open the Workshop along with Jacques Morénas," said Bruce Davis, ISPE Chairman of the Board.
Participants included those from:
- Asia Pacific: Australia, Brunei, China, Hong Kong, India, Israel, Indonesia, Japan, Korea, Macao, Malaysia, New Zealand, Philippines, Singapore, Thailand, Taiwan, Vietnam
- Europe: Czech Republic, Denmark, Finland, France, Germany, Hungary, Latvia, Netherlands, Norway, Slovak Republic, Sweden, Switzerland, Ukraine, United Kingdom
- North America: Canada, United States
- South Africa
About PIC/S
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international instrument between competent authorities, which provide together an active and constructive co-operation in the field of GMP. PIC/S' mission is "to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products." This is to be achieved by developing and promoting harmonised GMP standards and guidance documents; training competent authorities, in particular inspectors; assessing (and reassessing) inspectorates; and facilitating the co-operation and networking for competent authorities and international organisations. There are currently 31 Participating Authorities in PIC/S (Convention and Scheme taken together).
About ISPE
The International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical manufacturing professionals in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, USA, Brussels, Belgium, and an office in Singapore to serve Asia-Pacific.
http://www.ISPE.org
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