FDA Emphasizing Supplier Controls

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.

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Pharmaceutical Compounding

USP<797> (Pharmaceutical Compounding – Sterile Preparations) became effective in 2004. 460.200 – Pharmacy Compounding Guidance was issued by FDA in 2002. The FDA has issued Warning Letters to pharmacy compounding facilities in violation of requirements outlined in <797> and 460.200, and FDA oversight of compounding facilities has increased. GQA can provide expertise in auditing to meet these requirements as well as design and develop procedures, systems, and facilities.

GQA has worked with several compounding pharmacies to evaluate their compliance to USP <797> and the FDA guidance document. We have the experience and background to help with developing and improving the systems to ensure compliance.

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21 CFR 111 Compliance

The FDA has issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. These new regulations will require that dietary supplement manufacturers put into place proper controls to insure that dietary supplements are processed in a consistent manner and meet quality standards. The final rule has been staggered over a three-year period based on the size of the organization. The final CGMPs are effective June 2008 for large companies, June 2009 for companies with less than 500 employees, and June 2010 for companies with less than 20 employees.

GQA can assist in the assessment and development of quality systems to meet this new standard. Contact us to discuss your specific needs.

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