by Dr. Yashashwini Reddy | Sep 10, 2025
🏭 Guidelines for Preparation of Site Master File (SMF) 📑 1. General Information Company name, address, and contact details. Name of parent company (if applicable). Manufacturing activities performed at the site. Products handled (human, veterinary, APIs, biologicals,...
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....
