Pharmaceutical Quality Control Laboratory Audit Checklist

A comprehensive checklist for auditing pharmaceutical quality control laboratories to ensure compliance with GMP/GLP standards, enhance analytical testing reliability, and support overall product quality assurance.

Pharmaceutical Quality Control Laboratory Audit Checklist
by: audit-now
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About This Checklist

Quality control laboratories play a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products. This Pharmaceutical Quality Control Laboratory Audit Checklist is designed to comprehensively evaluate the processes, systems, and practices involved in testing and analyzing drug substances, excipients, and finished products. By assessing factors such as analytical method validation, equipment qualification, sample management, data integrity, and documentation practices, this checklist helps pharmaceutical companies maintain robust quality control systems. Implementing this audit process can significantly enhance the reliability of test results, ensure compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards, and support overall product quality assurance.

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Industry

Pharmaceuticals

Standard

ICH Q7, FDA 21 CFR Part 211, EU GMP Annex 1

Workspaces

Pharmaceutical quality control laboratories

Occupations

Quality Control Manager
Analytical Chemist
Laboratory Auditor
GMP Compliance Specialist
Microbiologist

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