For virtual companies, GQA can oversee the responsibilities for the QC unit. In fact, GQA has successfully held the position of QA and QC Site Head for several virtual companies over the last 7 years.
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.