SQA SQA Regulatory Compliance and GxP

Question 1

Which US federal agency primarily regulates pharmaceutical manufacturing quality standards that SQA professionals must comply with?

Accepted Answer

FDA

Answer

EPA

Answer

OSHA

Answer

CDC

Question 2

What does 'GxP' stand for in the context of SQA regulatory compliance?

Accepted Answer

Good Practice guidelines across multiple disciplines

Answer

Global Exchange Protocol

Answer

General Quality Procedure

Answer

Government Experimental Protocol

Question 3

Which regulation governs Good Laboratory Practice (GLP) compliance in non-clinical safety studies in the US?

Accepted Answer

21 CFR Part 58

Answer

21 CFR Part 11

Answer

21 CFR Part 820

Answer

21 CFR Part 210

Question 4

What is the primary purpose of a Quality Management System (QMS) in a GxP-regulated environment?

Accepted Answer

To ensure consistent product quality and regulatory compliance

Answer

To reduce manufacturing costs

Answer

To speed up product approval timelines

Answer

To manage employee performance reviews

Question 5

Under 21 CFR Part 11, what must be used to ensure the authenticity of electronic records in FDA-regulated industries?

Accepted Answer

Electronic signatures

Answer

Digital watermarks

Answer

Paper backup copies

Answer

Blockchain timestamps

Question 6

Which document defines the procedures and acceptance criteria for a validation study in compliance with FDA GMP?

Accepted Answer

Validation Protocol

Answer

Standard Operating Procedure

Answer

Batch Record

Answer

Product Specification