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…
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…
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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