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Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can relia…

Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliab…

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

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

Data integrity refers to the accuracy, completeness and consistency of GxP data over its entire lifecycle. The steps that need to be overseen i…

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