Quality Systems and GMP Flashcards

A pharmaceutical manufacturer receives a batch of active pharmaceutical ingredient that fails identity testing. What is the required disposition?

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.

Which document formally establishes the acceptance criteria used to evaluate validation results?

Answer: Validation protocol

The validation protocol is written before execution and establishes the pre-approved acceptance criteria that results must meet.

ICH Q7 Good Manufacturing Practice guidance primarily applies to which type of product?

Answer: Active pharmaceutical ingredients

ICH Q7 specifically addresses GMP requirements for APIs used in the production of human and veterinary drug products.

What is the regulatory basis for requiring expiration dates on pharmaceutical products in the US?

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.

Under GMP, when is a written deviation report required?

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.

Which GMP principle does the concept of 'cleaning validation' directly support?

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.

What is the significance of a 'retrospective validation' approach?

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.