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GMP Process Validation

Inspection of Process Validation
Do your validation processes meet their specified requirements?

This bilingual guide offers an excellent up-to-date approach on process validation. It facilitates the planning and execution of all necessary steps to be compliant.

NEW ++ NEW ++ NEW

 
 
Qualification and Validation: Agency Expectations
A qualification serves to prove that equipment is fit for its given purpose. So far, so good. But what are the actual fundamental requirements for a successful equipment qualification and what are the core elements of qualification work?

 
 
A Pharma Guide to Cleaning Validation
Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP Guidelines?
This report offers you practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.

 
 
Principles of Equipment Qualification
This pdf download lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ - that satisfies US and EU requirements.

incl. checklists for carrying out a qualification plan and instructive diagrams

 
 
Managing Process Validation
A step-by-step guide based on real-world examination experience. Discover how to document process validation in a way that is sure to satisfy — and impress — regulators!

 
 
 
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