Drug GMP Report

The FDA is implementing specialized training courses instructing agency inspectors on how to identify data integrity and fraud issues that have surfaced within the last two years, according to Edwin Rivera-Martinez, branch chief for the Manufacturing Assessment and Preapproval Compliance Branch in the Office of Compliance.

The European Medicines Agency (EMEA) recommended the market reintroduction of Roche’s HIV treatment Viracept after the company recalled all batches of the drug due to a manufacturing error, but the firm does not anticipate sales of the product to reach previous levels as patients have since switched to other treatments, Roche told DGR last month.

The FDA will no longer accept submissions for approximately 50 types of manufacturing supplements, according to a draft guidance the agency plans to release in the next few months, Helen Winkle, director of the Center for Drug Evaluation and Research’s Office of Pharmaceutical Science, said last month.

Biologic drug manufacturers that rely on spore-bearing organisms such as bacteria to make products such as vaccines may do so in either a separate facility or a contained portion of a larger plant, according to a new guidance from the FDA.

The FDA’s Office of Biotechnology Products (OBP) plans to commence a quality by design (QbD) pilot program within the next two months, Helen Winkle, director of the Office of Pharmaceutical Science (OPS), said last month at the Parenteral Drug Association’s (PDA)/FDA 2007 Joint Regulatory Conference.

Recalls for products regulated by the FDA’s Center for Drug Evaluation and Research (CDER) were up 170 percent in fiscal 2007, according to data released by the agency last month.

The FDA has ordered that active pharmaceutical ingredients (APIs) manufactured at a Kunshan Chemical & Pharmaceutical production facility be denied entry into the U.S., according to a Sept. 6 warning letter.

MedImmune said it has resolved the problems the FDA pointed out in a March warning letter concerning the company’s UK manufacturing facility for its influenza vaccine, FluMist.

The FDA needs to increase inspections and ensure the safety of imported products over their life cycles to prevent counterfeit and substandard drugs from entering the U.S. drug supply chain, witnesses and lawmakers said during a House Subcommittee on Health hearing last month.

Company employees should be aware of the FDA’s focus on determining individuals responsible for GMP violations found during inspections, Parexel Consulting Vice President of Strategic Compliance Services David Chesney said at an FDAnews audioconference.

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Under legislation President Bush signed into law Sept. 27 reauthorizing the Prescription Drug User Fee Act (PDUFA), HHS is tasked with developing a standard numerical identifier for tracking drugs in the supply chain.

Adaptive clinical trial designs derive much of the promise they hold for sponsors of oncology trials from real-time reporting and analysis of the data, which can only be accomplished by electronic means, according to an expert speaking at a recent conference sponsored by the Center for Business Intelligence.

When it comes to records, whether print or electronic, quality and integrity are key issues, former FDA official Stan Woollen said at an RxTrials Institute audioconference.

Pharmaceutical companies should be developing the capabilities to submit common technical document (CTD) applications electronically, Gary Buehler, director of the FDA’s Office of Generic Drugs (OGD), said.

Fulcrum Pharma, a drug development and regulatory services company, and Lorenz Life Sciences have formed an alliance to develop products and software for the drug development process, Fulcrum announced.