Quality Metrics – New FDA Guideline

The term “Quality Metrics” means all those indicators that give an idea of ​​the collective quality characteristics of a certain production site. The number of rejected batches per year compared…

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Infrastructure Qualification Procedure – Quality IT

Standard Operating Procedure (SOP) for IT Infrastructure Qualification of Computer System used in cGxP environment at the pharmaceutical company. Computer System - IT Infrastructure Qualification 1.0   Objective  This Procedure defines…

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Programmable Logic Controller (PLC) Qualification

Protocol and Procedure for Installation Qualification of Programmable Logic Controller (PLC) connected with Manufacturing Equipment. Installation Qualification of Programmable Logic Controller (PLC) 1.0   Objective : The objective of this protocol…

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