by Naveen kumar | 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 Naveen kumar | Nov 25, 2024
Terminal Sterilization Methods in Pharmaceuticals Terminal sterilization is a key process in pharmaceutical manufacturing to ensure that drug products are free of harmful microorganisms. It is performed on the final product, typically in its sealed container, to...
by Naveen kumar | Oct 18, 2024
Injectable In-Process Quality Assurance (IPQA) Department: A Key to Quality Injectable Manufacturing Injectable products play a critical role in healthcare by delivering medications directly into the bloodstream, ensuring quick action. The manufacturing of these...
by Naveen kumar | May 23, 2024
1.0 OBJECTIVE The objective of this Standard Operating Procedure (SOP) is to establish a consistent and controlled process for the procurement, storage, handling, and disposal of biological indicators used for the qualification and monitoring of sterilization...
by Naveen kumar | May 21, 2024
Operating of Horizontal Double door Autoclave 1.0 OBJECTIVE The objective of this Standard Operating Procedure (SOP) is to provide detailed, step-by-step instructions for the proper operation of a double-door autoclave used for sterilization purposes. 2.0 SCOPE This...
