BioProcess Blog |

Susan Dana Jones will be representing BPTC at this year’s ESACT conference in Vienna, Austria, May 15-18. To meet with Dr. Jones at the conference, click here.

By James Blackwell  (jblackwellbptccom)  , Patti Seymour  (pseymourbptccom)  , and Howard Levine  (hlevinebptccom)  

More than two years after the draft was initially issued, FDA has finalized the much anticipated Guidance for Industry Process Validation: General Principles and Practices, confirming the agency’s effort to take a more modern risk-based approach to validation.

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by Howard Levine  (hlevinebptccom)  , Alex Kanarek  (akanarekbptccom)  , James Blackwell  (jblackwellbptccom)  , and Patti Seymour  (pseymourbptccom)  

When FDA published its draft guidance Process Validation: General Principles and Practices in November 2008, the response from industry was so strong that the agency extended its deadline for comments well beyond the normal two months. Almost two years later, the guidance remains in draft form despite FDA’s assurance in June of this year that issuing the final guidance is a priority for 2010. The comments posted on the regulations.gov website regarding the draft guidance were not unexpected, such as highlighting concerns over the need to harmonize the recommendations with ICH Guidelines, clarifying language in the Guidance, and a desire not to abandon the traditional reliance on three consecutive conformance batches as an essential component of process validation. Others expressed concern over the potential for confusion in the use of the term “qualification” and a lack of guidance on the manufacture of investigational products.

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