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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Analytical Method Transfer (USP 1224) Guideline

Analytical Method Transfer (also called ‘Method Transfer’): A documented process that qualifies a laboratory (i.e., the Receiving Unit) to use an analytical test procedure that originated in another laboratory (i.e.,…

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Quality Assurance in Laboratory (Lab QA) – Guideline

Standard Operating Procedure (SOP) & Guideline to define the role and responsibility of Quality Assurance in Laboratory (as Lab QA) in different activities. Role & Responsibility of Quality Assurance in…

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