by Dr. Yashashwini Reddy | Apr 20, 2025
Standard Operating Procedure (SOP) 1. Purpose: To define the procedure for managing and handling non-conforming products (NCP) in order to identify, segregate, and address quality issues, ensuring that only conforming products are released for use,...
by Dr. Yashashwini Reddy | Nov 1, 2024
Understanding Why-Why Analysis in Pharmaceuticals: Uncovering the Root of Quality Issues The Why-Why analysis, or “5 Whys,” is a structured root cause analysis method widely used in the pharmaceutical industry to identify and resolve issues at their...
by Dr. Yashashwini Reddy | May 30, 2024
SOP ON ROLES AND RESPONSIBILITIES OF QA DEPARTMENT 1.0 Objective: To outline the roles and responsibilities of the quality assurance department 2.0 Scope: This SOP shall be applicable to Personnel working in quality assurance and activities of QA department. 3.0...
by Dr. Yashashwini Reddy | May 28, 2024
Departure from an approved procedure, instruction, or documented procedure is called deviation. A deviation should be properly documented and handled. A deviation can occur during the manufacturing, testing, storage, or distribution of pharmaceuticals. Deviations most...
by Dr. Yashashwini Reddy | May 25, 2024
Hold Time Study in Pharmaceutical Manufacturing: We know that the quality, safety, and efficacy of the medicine we produce are paramount. The pharmaceutical industry should develop a system in place to ensure the above such that the products we produce are of quality....
