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
A Systematic Investigation of Out-of-Specification (OOS) Results in Analytical Testing is a structured approach to identify, evaluate, and resolve instances where test results fall outside predefined specifications. This process is vital in pharmaceutical quality...
by Dr. Yashashwini Reddy | May 12, 2025
Standard Operating Procedure (SOP) Here is a Standard Operating Procedure (SOP) for the Cleaning of Automatic Coating System, used primarily for film/sugar coating of tablets in pharmaceutical manufacturing. 1. Objective To lay down the...
by Dr. Yashashwini Reddy | May 6, 2025
Here’s a detailed checklist for auditing an ointment manufacturing facility, aligned with Good Manufacturing Practices (GMP), regulatory expectations (such as USFDA, WHO, EU-GMP), and quality standards. The checklist is categorized for clarity: 1. General...
by Dr. Yashashwini Reddy | May 3, 2025
Improving pharmaceutical productivity and product quality is essential to meet the growing global demand for effective and safe medications. This can be achieved through a combination of strategies that address various aspects of pharmaceutical manufacturing, from raw...
