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 … Continue reading
Compounding PharmacyUSP<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.