SQA Regulatory Compliance and GxP Flashcards

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

Answer: FDA

The FDA sets and enforces GMP regulations for pharmaceutical and biotech manufacturing quality standards in the US.

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

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.

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

Answer: 21 CFR Part 58

21 CFR Part 58 establishes FDA requirements for Good Laboratory Practice for Nonclinical Laboratory Studies.

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

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.

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

Answer: Electronic signatures

21 CFR Part 11 requires electronic signatures to authenticate electronic records and ensure their integrity and non-repudiation.

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

Answer: Validation Protocol

A Validation Protocol is the pre-approved document that defines scope, approach, acceptance criteria, and responsibilities for a validation study.