In the wake of recent drug quality incidents such as heparin contamination, the FDA is seriously considering how drug ingredient supply chains need to be audited, according to staff from CDER’s Officer of Compliance.
Steve Wolfgang, a consumer safety officer with the Division of Manufacturing and Product Quality, made the statement 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 ingredient price and less on the ability to trace ingredients.
He emphasized the importance of drug makers’ 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.
Wolfgang said he could not say whether changes to regulations are under consideration when asked if the FDA plans to require firms to audit their suppliers. He said current GMP rules are strong and give the FDA the authority to focus on the ingredient supply chain.