Technical Agreement – Preparation & Handling

Standard Operating Procedure for preparation and handling of different types of Technical Agreement. Agreement undertook by written and legally binding on two parties (Contract giver and contract acceptor). Technical Agreement…

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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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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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