by Dr. Yashashwini Reddy | May 13, 2025
Standard Operating Procedure (SOP) Here is a complete Standard Operating Procedure (SOP) for the Cleaning of Clean Area (Sterile Area) in pharmaceutical manufacturing, ensuring compliance with GMP and sterile environmental control requirements. 1.0...
by Dr. Yashashwini Reddy | May 13, 2025
Standard Operating Procedure (SOP) 1.0 Objective To lay down the procedure for cleaning, sanitization, and verification activities required to resume aseptic area operations after any maintenance work, ensuring compliance with GMP and sterility...
by Dr. Yashashwini Reddy | May 3, 2025
Restricted Access Barrier System (RABS) in Pharmaceuticals – Detailed Explanation 1. Introduction A Restricted Access Barrier System (RABS) is a contamination control technology used in the pharmaceutical industry, particularly in aseptic processing environments. It...
by Dr. Yashashwini Reddy | Apr 26, 2025
Standard Operating Procedure (SOP) 1. Purpose To establish a standardized method for qualifying personnel in proper gowning procedures to ensure compliance with cleanliness and contamination control requirements in controlled environments...
by Dr. Yashashwini Reddy | Apr 13, 2025
The implementation of pharmaceutical isolators in manufacturing is regulated by the Current Good Manufacturing Practices (CGMP) established by the FDA and the EU GMP guidelines, both of which are designed to ensure the quality and safety of pharmaceutical products....
