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 28, 2024
Basic Guidelines for Process Validation in Tablet Manufacturing Process validation is a critical component of pharmaceutical manufacturing that ensures each batch of tablets meets quality, safety, and efficacy standards. The following guidelines outline the...
by Naveen kumar | Nov 28, 2024
Out of Specifications (OOS) in Pharmaceuticals Out of Specification (OOS) results occur when the test results of a pharmaceutical product fall outside the predefined acceptance criteria specified in regulatory guidelines or quality standards. These deviations are...
by Naveen kumar | Nov 22, 2024
What is a Validation Protocol? A Complete Guide for the Pharmaceutical Industry In the pharmaceutical industry, achieving and maintaining high standards of quality is non-negotiable. A validation protocol is one of the critical tools that ensure processes, equipment,...
by Naveen kumar | Oct 18, 2024
Role of the Technology Transfer Department in the Pharmaceutical Industry The Technology Transfer (TT) department is essential in moving pharmaceutical products from development to full-scale manufacturing. Their primary role is to ensure a seamless transfer of...
