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01-Jun-2016 12:40

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The procedures set out in this SOP apply to qualitative and quantitative analytical methods which are used to test finished goods, in-process material, excipients and raw materials in support of registration documentation and cleaning validations and management responsibilities towards completing those method validation tasks.

All manuals and procedures are written by area experts in example formats in order to comply with c GMP, GLP, GDP, GAMP and international regulatory agency's requirements.

Our goal is to provide a complete GMP & GLP models with a set of ready procedures and manuals which are easy to understand and readily applicable.

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.

This procedure provides a guideline for a validation Technician on the characteristics that must be considered during the validation of an analytical testing procedure.

All procedures are written with practical instructions and examples.

Forms and templates are referenced in the SOPs where applicable.

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Following is a list of manuals and procedures linked with sample pages.

For full version of manuals and procedures please read more by clicking the "Subscribe" button on the left.



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