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February 4, 2025

Audit Trail Verification for a Single Medicine Batch: A Comprehensive Guide

In the pharmaceutical industry, ensuring the safety, efficacy, and quality of medicines is paramount. Regulatory compliance and good manufacturing practices (GMP) demand a robust system for tracking and verifying every step in the production and distribution of pharmaceutical products. One such critical process is audit trail verification, which plays a vital role in maintaining transparency and accountability for a single […]

0 5 min read
January 16, 2025

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 […]

0 4 min read
January 16, 2025

HPLC Audit Trail Verification in Pharmaceutical Industry

Introduction High-Performance Liquid Chromatography (HPLC) is a critical analytical technique widely used in the pharmaceutical industry for the analysis of raw materials, intermediates, and finished products. Given its importance, ensuring the integrity and traceability of data generated by HPLC systems is essential to maintain compliance with regulatory standards such as FDA’s 21 CFR Part 11, EU GMP Annex 11, and […]

0 4 min read