SQA SQA Regulatory Compliance and GxP 1 — Questions and Answers
Question 1: Which US federal agency primarily regulates pharmaceutical manufacturing quality standards that SQA professionals must comply with?
- FDA (Correct answer)
- EPA
- OSHA
- CDC
Correct answer: FDA
The FDA sets and enforces GMP regulations for pharmaceutical and biotech manufacturing quality standards in the US.
Question 2: What does 'GxP' stand for in the context of SQA regulatory compliance?
- Good Practice guidelines across multiple disciplines (Correct answer)
- Global Exchange Protocol
- General Quality Procedure
- Government Experimental Protocol
Correct answer: Good Practice guidelines across multiple disciplines
GxP is a collective term for Good Practice guidelines including GMP, GLP, GCP, and GDP that govern regulated industries.
Question 3: Which regulation governs Good Laboratory Practice (GLP) compliance in non-clinical safety studies in the US?
- 21 CFR Part 58 (Correct answer)
- 21 CFR Part 11
- 21 CFR Part 820
- 21 CFR Part 210
Correct answer: 21 CFR Part 58
21 CFR Part 58 establishes FDA requirements for Good Laboratory Practice for Nonclinical Laboratory Studies.
Question 4: What is the primary purpose of a Quality Management System (QMS) in a GxP-regulated environment?
- To ensure consistent product quality and regulatory compliance (Correct answer)
- To reduce manufacturing costs
- To speed up product approval timelines
- To manage employee performance reviews
Correct answer: To ensure consistent product quality and regulatory compliance
A QMS integrates all quality-related processes to ensure products consistently meet quality standards and regulatory requirements.
Question 5: Under 21 CFR Part 11, what must be used to ensure the authenticity of electronic records in FDA-regulated industries?
- Electronic signatures (Correct answer)
- Digital watermarks
- Paper backup copies
- Blockchain timestamps
Correct answer: Electronic signatures
21 CFR Part 11 requires electronic signatures to authenticate electronic records and ensure their integrity and non-repudiation.
Question 6: Which document defines the procedures and acceptance criteria for a validation study in compliance with FDA GMP?
- Validation Protocol (Correct answer)
- Standard Operating Procedure
- Batch Record
- Product Specification
Correct answer: Validation Protocol
A Validation Protocol is the pre-approved document that defines scope, approach, acceptance criteria, and responsibilities for a validation study.
SQA SQA Regulatory Compliance and GxP 1
Which US federal agency primarily regulates pharmaceutical manufacturing quality standards that SQA professionals must comply with?