by Dr. Yashashwini Reddy | May 2, 2025
Revalidation plays a critical role in maintaining product quality and ensuring regulatory compliance in pharmaceutical manufacturing. It is an essential component of Good Manufacturing Practices (GMP) and a requirement by regulatory authorities like the FDA, EMA, and...
by Dr. Yashashwini Reddy | Apr 26, 2025
Standard Operating Procedure (SOP) 1. Purpose To define the procedure for the qualification and validation of visual checking inspectors, ensuring that they have the necessary skills and knowledge to accurately perform inspections and meet...
by Dr. Yashashwini Reddy | Apr 23, 2025
Standard Operating Procedure (SOP) Here is a Standard Operating Procedure (SOP) for Sampling and Release of In-Process Samples. This SOP outlines the process for properly sampling and releasing in-process samples to ensure quality control...
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
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...
