Which entity conducts inspections of outsourcing facilities to ensure CGMP compliance?

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Prepare for the PTCB Supply Chain and Inventory Management Test with flashcards and multiple choice questions, complete with hints and explanations. Enhance your pharmacy tech skills and ace your exam!

Multiple Choice

Which entity conducts inspections of outsourcing facilities to ensure CGMP compliance?

Explanation:
Inspections to confirm CGMP compliance for outsourcing facilities are conducted by the FDA. Outsourcing facilities—those that compound sterile drug products under 503B—must follow CGMP and register with FDA, which sends inspectors to review manufacturing controls, quality systems, facilities, equipment, personnel training, batch records, and sterility testing. The goal is to verify that the products meet quality and safety standards before they enter the market. Other agencies don’t oversee CGMP for these facilities: CBP handles import/export and border control, FTC covers advertising and consumer protection, and EPA focuses on environmental regulations.

Inspections to confirm CGMP compliance for outsourcing facilities are conducted by the FDA. Outsourcing facilities—those that compound sterile drug products under 503B—must follow CGMP and register with FDA, which sends inspectors to review manufacturing controls, quality systems, facilities, equipment, personnel training, batch records, and sterility testing. The goal is to verify that the products meet quality and safety standards before they enter the market. Other agencies don’t oversee CGMP for these facilities: CBP handles import/export and border control, FTC covers advertising and consumer protection, and EPA focuses on environmental regulations.

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