by Dr. Yashashwini Reddy | Oct 9, 2025
Analytical procedure development is the process of designing and optimizing methods to accurately and precisely measure the active pharmaceutical ingredient (API), excipients, impurities, and degradation products in a drug substance or drug product. The goal is to...
by Dr. Yashashwini Reddy | Sep 9, 2025
🔐 Why Data Integrity is More Important Than Ever? 1. Patient Safety at the Core Medicines are only as safe as the data proving their quality. Any falsified, incomplete, or inaccurate record may lead to unsafe products reaching patients. Strong data integrity ensures...
by Dr. Yashashwini Reddy | Sep 6, 2025
Planning and Procedure Followed During Regulatory Audits Regulatory audits (by USFDA, EMA, MHRA, WHO, or local authorities) are conducted to verify compliance with cGMP and regulatory standards. Effective preparation and systematic execution are crucial for success....
by Dr. Yashashwini Reddy | Sep 6, 2025
10 Step Guide to cGMP Certification cGMP (Current Good Manufacturing Practices) certification demonstrates that a company’s facilities, processes, and quality systems comply with international regulatory standards (FDA, EMA, WHO, PIC/S). It assures product quality,...
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...
