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.
RAC Quality Systems and GMP 2
Under 21 CFR Part 211, which document must be prepared and followed for each batch of drug product?