The QMN Weekly Bulletin

FDA Considering How Supply Chain Needs Auditing

July 25, 2008

In the wake of recent drug quality incidents such as the heparin contamination, the FDA is seriously considering how drug ingredient supply chains need to be audited, according to staff from the Center for Drug Evaluation and Research’s Office of Compliance.

Steve Wolfgang, a consumer safety officer with the Division of Manufacturing and Product Quality, made the statement last month at the International Society for Pharmaceutical Engineering’s 2008 Engineering Regulatory Compliance conference.

Noting the importance of using stronger supplier qualification programs and increasing the frequency of vendor audits, Wolfgang said supplier agreements often focus more on price and less on the ability to trace ingredients.

He emphasized the importance of drugmakers’ audits of ingredient suppliers to ensure there are no unknown GMP deficiencies. He also encouraged companies to pay attention to suppliers’ GMP and good distribution practices.

When asked if the FDA plans to require firms to audit their suppliers, Wolfgang said he could not say whether changes to regulations are under consideration. He said current GMP rules are strong and give the agency the authority to focus on the ingredient supply chain.

He also said some authorities the agency might not have on drug ingredients would be granted under legislation pending in Congress. The FDA Globalization Act, for which the House has held a series of hearings, would require documentation of the origins of pharmaceutical ingredients. It also would mandate preapproval inspections and require manufacturers of drugs and drug ingredients to establish where such chemicals are produced.