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....
by Dr. Yashashwini Reddy | Nov 29, 2024
Advanced Questions and Answers on MS&T in Injectable Plants – Part 2 1. Troubleshooting and Continuous Improvement Question: What approach do you follow to troubleshoot a batch failure? Answer: Conduct a root cause analysis using tools like fishbone diagrams or 5...
by Dr. Yashashwini Reddy | Nov 28, 2024
Personal Protective Equipment (PPE) in the Pharmaceutical Industry: Essential Tools for Safety and Compliance Personal Protective Equipment (PPE) plays a critical role in ensuring the safety of workers, maintaining product integrity, and preventing contamination in...
by Dr. Yashashwini Reddy | Sep 23, 2024
Importance of Clean Rooms in the Pharmaceutical Industry Clean rooms are vital in the pharmaceutical industry as they provide a controlled environment where the level of contaminants such as dust, microorganisms, and airborne particles is minimized. This contamination...
