The Documents required during the activities of CSV are very important for the quality, safety, and efficacy of  the final product. As per regulatory requirem…

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Live Webinar Session On Dated 31.12.2021 for Computer Sytem Validation Topic for your Knowledge 1. Basic Regulerty Guideline 2. Basic CSV Approch 3. Mor…

This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of …

Lets discuss about analytical instrument qualification.    Please Subscribe my You tube Channel   Watch Full Section Click Link …

How to Qualify Analytical Instrument, Different Qualification approch.                                                                        Please Subsc…

Each country has its own regulatory authority, which is responsible to enforce the rules, regulations and issue the guidelines to regulate the drug developm…

Video on How to write Simple SOP, Reduce Number of Entries, Reduce Checkpoints and Increase Productivity and Reduce Menpower                               …

Definitions:  System :-   A group / part of things that work together, in other words "A set of ideas or rules or component for organizing the things in a…

Previous Chapter: Discussed about the preparation of Installation qualification document and test.  Lets discuss about, How to prepare Operational Qualific…

Many peoples are facing the issue for preparation of IQ and what are the tests to be performed in IQ. So Ugine are recommended the following test steps and s…