SQA SQA Regulatory Compliance and GxP 2 — Questions and Answers
Question 1: What is a CAPA in the context of SQA regulatory compliance?
- Corrective and Preventive Action (Correct answer)
- Compliance Audit Procedure Assessment
- Critical Area Process Analysis
- Controlled Action Performance Audit
Correct answer: Corrective and Preventive Action
CAPA stands for Corrective and Preventive Action, a systematic FDA-required process to eliminate causes of non-conformances.
Question 2: Which FDA regulation covers Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals?
- 21 CFR Parts 210 and 211 (Correct answer)
- 21 CFR Part 58
- 21 CFR Part 820
- 21 CFR Part 312
Correct 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.
Question 3: What is the purpose of an FDA Form 483 issued during an inspection?
- To list inspectional observations and potential violations found (Correct answer)
- To approve a facility for commercial manufacturing
- To certify an auditor as GMP qualified
- To grant an import license for foreign products
Correct 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.
Question 4: What is an FDA Warning Letter?
- An official FDA communication indicating significant regulatory violations requiring prompt corrective action (Correct answer)
- A preliminary notice of an upcoming routine inspection
- A request for additional product testing samples
- A routine notification about labeling updates
Correct 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.
Question 5: Which concept requires that pharmaceutical manufacturing processes consistently reproduce output meeting predetermined specifications?
- Process Validation (Correct answer)
- Risk Assessment
- Change Control
- Out-of-Specification Investigation
Correct answer: Process Validation
Process Validation demonstrates that a manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes.
Question 6: In GxP compliance, what does 'data integrity' primarily require?
- Data must be Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) (Correct answer)
- Data must be stored in encrypted databases only
- Data must be reviewed by a third-party auditor monthly
- Data must be printed and signed within 24 hours of collection
Correct 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.
SQA SQA Regulatory Compliance and GxP 2
What is a CAPA in the context of SQA regulatory compliance?