RAC Quality Systems and GMP 2 — Questions and Answers
Question 1: Under 21 CFR Part 211, which document must be prepared and followed for each batch of drug product?
- Master batch record
- Batch production record (Correct answer)
- Device history record
- Design history file
Correct answer: Batch production record
21 CFR 211.188 requires a batch production record prepared for each batch as an accurate reproduction of the master production record.
Question 2: Which GMP regulation governs Current Good Manufacturing Practice for finished pharmaceuticals in the US?
- 21 CFR Part 820
- 21 CFR Part 211 (Correct answer)
- 21 CFR Part 600
- 21 CFR Part 110
Correct answer: 21 CFR Part 211
21 CFR Part 211 establishes CGMP requirements for finished pharmaceutical products manufactured in the US.
Question 3: What is the primary purpose of an Annual Product Review (APR) in pharmaceutical manufacturing?
- To satisfy FDA pre-approval inspection requirements
- To assess consistency of existing processes and identify improvements (Correct answer)
- To validate new manufacturing equipment
- To document supplier qualification activities
Correct answer: To assess consistency of existing processes and identify improvements
APRs evaluate the consistency of existing processes, quality of raw materials, and product quality to identify opportunities for improvement.
Question 4: In a GMP environment, which out-of-specification (OOS) investigation step must occur before retesting?
- Regulatory notification
- Phase I laboratory investigation (Correct answer)
- CAPA implementation
- Batch disposition decision
Correct answer: Phase I laboratory investigation
FDA's 2006 OOS guidance requires a Phase I laboratory investigation to assess analyst error and instrument performance before any retesting.
Question 5: Which element is NOT a required component of a pharmaceutical quality system under ICH Q10?
- Management responsibility
- Continual improvement of the process
- Corrective and preventive action system
- Mandatory third-party audits (Correct answer)
Correct answer: Mandatory third-party audits
ICH Q10 requires management responsibility, CAPA, and continual improvement, but does not mandate third-party audits as a required element.
Question 6: What does the term 'qualification' refer to in the context of GMP equipment validation?
- Documenting that a process consistently produces a product meeting specifications
- Demonstrating that equipment is properly installed, operates correctly, and performs as intended (Correct answer)
- Verifying that analytical methods are suitable for their intended use
- Confirming that suppliers meet quality standards
Correct answer: Demonstrating that equipment is properly installed, operates correctly, and performs as intended
Equipment qualification (IQ/OQ/PQ) demonstrates that equipment is installed correctly, operates as designed, and performs consistently within specified parameters.
Question 7: Under 21 CFR 211.68, computerized systems used in drug manufacturing must have what safeguard?
- Dual-factor authentication for all users
- Input/output verification to ensure accuracy (Correct answer)
- Encryption of all stored data
- Quarterly system revalidation
Correct answer: Input/output verification to ensure accuracy
21 CFR 211.68 requires that input to and output from computerized systems be checked for accuracy to prevent data integrity failures.
