RAC Quality Systems and GMP 2

Question 1

Under 21 CFR Part 211, which document must be prepared and followed for each batch of drug product?

Accepted Answer

Batch production record

Answer

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?

Accepted Answer

21 CFR Part 211

Answer

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?

Accepted Answer

To assess consistency of existing processes and identify improvements

Answer

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?

Accepted Answer

Phase I laboratory investigation

Answer

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?

Accepted Answer

Mandatory third-party audits

Answer

ICH Q10 requires management responsibility, CAPA, and continual improvement, but does not mandate third-party audits as a required element.

(RAC) Regulatory Affairs Certification Practice Test