IPQ Monthly Update — September 2011 in Review

The challenges of regulating a global pharmaceutical supply chain are prompting significant changes in the way FDA is operating and its interconnections to the wider regulatory community.  IPQ’s Monthly Update for September explores these changes as the agency strives to match its far-reaching responsibilities with its resource limitations and, in conjunction with other international regulators, create a more efficient and better coordinated oversight approach.

The IPQ stories in this issue delve into:

● the experience FDA has had in setting up offices located abroad and the objectives and accomplishments of the India office in particular

● how the increasing interagency communication is impacting FDA’s GMP inspection and enforcement program

● the agency’s renewed plea to Congress for more tools to help it combat the myriad global threats to product quality and integrity, and

● hearings held by Congress and FDA to explore the causes and potential solutions to the increasingly critical problem of drug shortages.

The IPQ issue also addresses the efforts outside of FDA to help manufacturers make sure that their products successfully navigate the supply chain shoals and the patient receives the full benefit of the quality that was built into them.  In focus are recent contributions to the GDP library by WHO, USP and PDA – what they target and how they differ.

Another pair of stories in the Monthly Update take a deep dive into the BLA CMC review process at FDA – focusing on where companies are falling short in their submissions and what the agency is advising on how to improve them.

The first story takes a broader CMC vantage point, highlighting the agency’s recent experience with manufacturing change supplements, while the second hones in on the industry/reviewer interface with analytical methods in particular and their importance in assuring a smooth CMC review process, especially in the biologics context.

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