SQA Regulatory Compliance and GxP Flashcards

What is a CAPA in the context of SQA regulatory compliance?

Answer: Corrective and Preventive Action

CAPA stands for Corrective and Preventive Action, a systematic FDA-required process to eliminate causes of non-conformances.

Which FDA regulation covers Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals?

Answer: 21 CFR Parts 210 and 211

21 CFR Parts 210 and 211 establish minimum cGMP requirements for the manufacture, processing, packing, and holding of drug products.

What is the purpose of an FDA Form 483 issued during an inspection?

Answer: To list inspectional observations and potential violations found

An FDA Form 483 is issued at the close of an inspection to list observations where investigators found conditions that may violate regulations.

What is an FDA Warning Letter?

Answer: An official FDA communication indicating significant regulatory violations requiring prompt corrective action

An FDA Warning Letter is a serious regulatory action notifying a company of significant violations that must be corrected or further enforcement will follow.

Which concept requires that pharmaceutical manufacturing processes consistently reproduce output meeting predetermined specifications?

Answer: Process Validation

Process Validation demonstrates that a manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes.

In GxP compliance, what does 'data integrity' primarily require?

Answer: Data must be Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA)

Data integrity in GxP requires data to meet the ALCOA principles: Attributable, Legible, Contemporaneous, Original, and Accurate.