CPGP Practice Questions - Certified Pharmaceutical GMP Professional Exam

What is the relationship between 21 CFR Part 210 and 21 CFR Part 211?

Part 210 applies to APIs and Part 211 to finished dosage forms Part 210 provides general cGMP definitions and Part 211 provides specific requirements for finished pharmaceuticals Part 210 covers laboratory controls and Part 211 covers production controls Part 210 is voluntary guidance and Part 211 is legally enforceable

Correct Answer:

Part 210 provides general cGMP definitions and Part 211 provides specific requirements for finished pharmaceuticals

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