by Dr. Yashashwini Reddy | Sep 6, 2025
Pharmaceutical companies operate under strict cGMP regulations enforced by agencies like FDA, EMA, MHRA, and WHO. Even well-established firms make compliance mistakes that can lead to FDA 483s, Warning Letters, recalls, or import alerts. Below are 8 of the most common...
by Dr. Yashashwini Reddy | Sep 6, 2025
Importance of Data Integrity for Pharmaceutical Regulatory Agencies 1. What is Data Integrity? Data integrity means maintaining the accuracy, completeness, consistency, and reliability of data throughout its lifecycle, ensuring it is attributable, legible,...
by Dr. Yashashwini Reddy | Sep 6, 2025
Regulatory Expectations from Cleaning Validation Cleaning validation is a documented evidence-based process to demonstrate that cleaning procedures effectively and consistently remove residues of products, cleaning agents, and contaminants to predetermined acceptable...
by Dr. Yashashwini Reddy | Sep 6, 2025
Current Good Manufacturing Practices (cGMP) in Pharmaceutical Industries Current Good Manufacturing Practices (cGMP) are the regulatory standards enforced by agencies like the USFDA, WHO, and EMA to ensure that pharmaceutical products are consistently produced and...
by Dr. Yashashwini Reddy | Sep 6, 2025
1.0 Purpose To lay down the procedure for the safe, secure, and documented transfer of finished goods from the production/packing area to the bonded store room under controlled conditions to ensure compliance with regulatory and company requirements. 2.0 Scope This...
