Pharmaceutical Manufacturing Under Scrutiny


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Across the board — from labeling and marketing, to clinical trials, to manufacturing processes — regulators are becoming more active in safeguarding the public and ensuring the safety of pharmaceuticals.
Even before the news broke regarding Genzyme Corp.’s recent virus and contamination problems (bits of steel, rubber, and fiber were found in drugs made by the company and shipped from the same site), the Food and Drug Administration had been increasing its presence in inspecting manufacturing facilities and ensuring companies are GMP compliant and meeting SOPs. In the case of Genzyme, Federal regulators also warned doctors about possible foreign particles in five Genzyme drugs used to treat rare genetic disorders, including two — Cerezyme and Fabrazyme — that have been rationed because of the viral contamination detected in the company’s Allston Landing plant last summer. The five drugs…

About GMP
Top Findings from Inspections

The top observations from manufacturing inspections from 2000 through Nov. 29, 2009

Experts on this topic
Ray Bouknight. Director, Validation and Compliance, Interphase Systems Inc., a ­management and technology consulting organization. For more information, visit or e-mail
Joe Goodman. Head of Solutions ­Consultants, Sparta Systems Inc., which ­provides global quality and compliance management systems. For more ­information, visit
Sharon Johnson. Senior VP of Global Quality and Regulatory Affairs, Catalent Pharma Solutions Inc., a provider of advanced dose form and packaging ­technologies, and development, ­manufacturing, and packaging services. For more information, visit
Philip Katz. Co-Director of the ­Pharmaceutical and Biotechnology Practice Group, Hogan & Hartson, an international law firm. For more information, visit or e-mail
Michael C. Rogers. Deputy Director, Office of Regional Operations, Food and Drug Administration, which is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the U.S. food supply, ­cosmetics, and products that emit radiation. For more information, visit
Rahsaan Thompson. Of Counsel, ­Quarles & Brady, which provides broad-based, national-level legal services through a network of regional practices and local offices. For more information, visit ­