by Dr. Yashashwini Reddy | Jun 9, 2025
Three Consecutive Batches for Validation in Pharmaceuticals Definition: In pharmaceutical manufacturing, validation is the documented evidence that a process consistently produces a product meeting its predetermined quality specifications. One of the critical...
by Dr. Yashashwini Reddy | May 19, 2025
What Is Revalidation? Revalidation involves repeating the original validation effort or a portion of it to confirm that a process, system, or equipment remains in a state of control. This process is essential when changes occur that could impact product quality or...
by Dr. Yashashwini Reddy | May 19, 2025
Sampling and Testing in Exhibit and Process Validation Batches Sampling and testing are pivotal components in the pharmaceutical industry’s process validation framework. They ensure that manufacturing processes consistently yield products meeting predefined...
by Dr. Yashashwini Reddy | May 19, 2025
Certainly! Let’s delve into the detailed distinctions between Process Validation and Product Validation, particularly within the pharmaceutical and medical device industries: Process Validation Definition: Process Validation is the collection and evaluation of...
by Dr. Yashashwini Reddy | May 7, 2025
Standard Operating Procedure (SOP) 1. Objective To establish a standardized method for the safe and efficient operation of the 20-station single rotary tablet compression machine, ensuring consistent tablet quality and compliance with Good...
