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Contact GQA
- 1-303-459-2382
- 1-866-216-2815
- info@gqaconsulting.com
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Industry Definitions
Compounding Pharmacy
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.
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Quality Systems Services