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New EU GMP Annex 15 Revision published – Valid as of 1 October 2015

April 7, 2015 by sjwilliamspa

EU regulatory changes adapted from the Regulatory blog of Dr. Melvin Crasto

New EU GMP Annex 15 Revision published – Valid as of 1 October 2015.

Reporter Stephen J. Williams, Ph.D.

courtesy of Dr. Melvin Crasto’s blog

EU and FDA offer new guidelines in recently published drafts on GMP (Good Manufacturing Procedures) and validation processes incorporating new manufacturing technologies throughout the drug developing and manufacturing life cycle.

The clear focus on user requirements in the area of qualification will also have an impact on equipment suppliers. Process validation will become a difficult task in the future. With 3 different approaches there are clear differences to the US. However, the ongoing process verification means additional effort and is now comparable to the US requirements.

This enhanced “across-the-sea” cooperation between FDA and EU is seeming to become the norm in the drug development world as once seemingly distinct lines separating US and EU companies have become blurred.