Procedure for Audit Trail Verification in Analytical Testing Laboratory For Drugs

Introduction Audit trail verification is a critical component in ensuring the integrity and compliance of data in an analytical testing laboratory. It ensures that all activities related to data generation, processing, and reporting are traceable and compliant with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and data integrity requirements, such as those outlined in the U.S. FDA’s 21 CFR […]

Audit Guidelines for Assessing Sufficient Qualified Personnel in an Analytical Testing Laboratory

Introduction The adequacy and qualification of personnel in an analytical testing laboratory are critical components of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Personnel competency directly impacts the reliability, accuracy, and compliance of analytical results. Auditors must carefully assess whether the laboratory has sufficient qualified staff to perform its operations effectively and in compliance with regulatory requirements. This […]