RAC Quality Systems and GMP 3 — Questions and Answers
Question 1: A pharmaceutical manufacturer receives a batch of active pharmaceutical ingredient that fails identity testing. What is the required disposition?
- Retest using a different method before rejecting
- Reject and return or destroy the material (Correct answer)
- Place in quarantine and notify the supplier only
- Use under a deviation if potency is acceptable
Correct answer: Reject and return or destroy the material
Under 21 CFR 211.84, components failing identity testing must be rejected and cannot be used in drug product manufacturing.
Question 2: Which document formally establishes the acceptance criteria used to evaluate validation results?
- Standard operating procedure
- Validation protocol (Correct answer)
- Batch production record
- Change control form
Correct answer: Validation protocol
The validation protocol is written before execution and establishes the pre-approved acceptance criteria that results must meet.
Question 3: ICH Q7 Good Manufacturing Practice guidance primarily applies to which type of product?
- Finished pharmaceutical dosage forms
- Active pharmaceutical ingredients (Correct answer)
- Biological drug products
- Medical device components
Correct answer: Active pharmaceutical ingredients
ICH Q7 specifically addresses GMP requirements for APIs used in the production of human and veterinary drug products.
Question 4: What is the regulatory basis for requiring expiration dates on pharmaceutical products in the US?
- 21 CFR Part 314
- 21 CFR 211.137 (Correct answer)
- 21 CFR Part 820
- 21 CFR 600.14
Correct answer: 21 CFR 211.137
21 CFR 211.137 requires expiration dating based on stability testing to ensure drug products meet specifications through their labeled shelf life.
Question 5: Under GMP, when is a written deviation report required?
- Only when product is released to market
- When an unexpected departure from an approved procedure occurs (Correct answer)
- Only for deviations discovered by FDA inspectors
- When a batch fails final release testing
Correct answer: When an unexpected departure from an approved procedure occurs
Any unexpected departure from an approved procedure during manufacturing must be documented in a deviation report to maintain GMP compliance and traceability.
Question 6: Which GMP principle does the concept of 'cleaning validation' directly support?
- Personnel qualification
- Prevention of cross-contamination between products (Correct answer)
- Environmental monitoring accuracy
- Equipment calibration frequency
Correct answer: Prevention of cross-contamination between products
Cleaning validation demonstrates that cleaning procedures effectively remove product residues and prevent cross-contamination between successive batches or products.
Question 7: What is the significance of a 'retrospective validation' approach?
- It validates a process before production begins
- It uses historical production data to validate an established process (Correct answer)
- It concurrently collects data during routine production
- It validates analytical testing methods
Correct answer: It uses historical production data to validate an established process
Retrospective validation uses accumulated historical batch data to demonstrate that an existing process has been operating in a state of control.
RAC Quality Systems and GMP 3
A pharmaceutical manufacturer receives a batch of active pharmaceutical ingredient that fails identity testing.
What is the required disposition?