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Here you will find the philosophy of validation, responsibilities, validation approaches of design qualification, installation qualification, operational qualification, performance qualification, cleaning validation, method validation, computer validation, general and specific criteria of validation, validation documentation and change control, validation reporting, guidelines of validation acceptance criteria.
This procedure contains step by step instruction on initiation of revalidation categories, changes that warrant revalidation programs, basic steps of revalidation procedure, revalidation activities and specific responsibilities, revalidation protocols, revalidation timing, equipment checklist, revalidation discrepancy procedure, release of revalidated equipment, preparation of the revalidation reporting file.
The aim of this validation guideline is to provide a clear statement of the scope, validation approach and testing required for the validation of the facilities and utilities that are involved, directly or indirectly, in the manufacturing processes at a GMP site.
This procedure is applicable to validation sampling and testing for all new product introductions, and when changes to manufacturing procedures, manufacturing equipment, or raw materials warrant process validation.
Content of our procedures are not only guidelines but detail know how instructions which will help you to build up your systems from scratch.
Following is a list of manuals and procedures linked with sample pages.
This SOP defines the procedures for conducting in house stand-alone trials on systems, processes and equipment.
There can be an overlap between a trial and validation in that Trial documentation may form part of a latter process validation, (i.e.
The plan pertains to the qualification of processes and laboratory equipment.
The purpose of this SOP is to define common procedures to follow when organizing Trials/Evaluation Studies for the purpose of process improvement, equipment capability and validation studies.