by Dr. Yashashwini Reddy | Jun 30, 2024
Important Interview Questions in Computer System Validation 1. What is data integrity in CSV? Ans: Data integrity in CSV refers to the consistency and accuracy of data through its entire lifecycle and it ensures data remains unchanged and remains in its original...
by Dr. Yashashwini Reddy | Jun 30, 2024
Computer system validation, if you are thinking about starting your career in CSV, then this article will give you an overview of what CSV is, and what is the role of CSV in the Pharma industry. CSV is a critical requirement of regulatory agencies. It aims to ensure...
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....
by Dr. Yashashwini Reddy | May 24, 2024
Standard Operating Procedure for Operation of Rapid Mixer Granulator 1.0 OBJECTIVE: To lay down the procedure for the operation of the Rapid Mixer Granulator in the granulation area of the production department 2.0 SCOPE: This SOP shall be applicable for the operating...
by Dr. Yashashwini Reddy | May 4, 2024
Whenever there is a need to address quality-related issues CAPA is initiated, examples of quality-related issues include deviations, non-conformances, market complaints, deficiency during internal audits, product recalls, etc. CAPA aims to address the issue in such a...