Understanding Pharmaceutical Waters

Water is a major requirement for the pharmaceutical industry. We cannot imagine life without water and even in pharmaceutical manufacturing water is one of the most important requirements and based on the regulatory requirements the standards for water are...

Frequently asked interview questions in CSV

    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...

What is Computer system Validation and Role of CSV specialist

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...

What are the Methods in Pharmacovigilance

Methods in Pharmacovigilance, this article will give you an overview of the pharmacovigilance methods and the concepts involved in it. Definition of Pharmacovigilance as per WHO:  science and activities relating to detecting, assessing, understanding, and preventing...

DMF submission Process

Drug Master File Submission Process We have discussed the types of drug master files and their purpose in the previous article now we will learn how a DMF is submitted to the FDA in short. Procedure for DMF submission Electronic Common Technical Document (eCTD): DMFs...

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