by Dr. Yashashwini Reddy | Jun 9, 2025
Purpose of Process Validation in Pharmaceuticals Process validation is a critical activity in pharmaceutical manufacturing that ensures a process consistently produces a product meeting its predetermined quality attributes. The purpose of process validation is to...
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 | Apr 24, 2025
Standard Operating Procedure(SOP) Great! Here’s a suggested title and outline for the SOP (Standard Operating Procedure) for Operational Qualification (OQ) of a Dissolution Tester, followed by some hashtags you can use if...
by Dr. Yashashwini Reddy | Jul 2, 2024
What is an Audit trail? In this article, we will learn about what an audit trail is, why it is required, and the contents of an audit trail. An audit trail is a 21 CFR Part 11 compliance requirement. These 21 CFR Part 11 deals with electronic records and electronic...
