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GMP Engineering

Qualification of Pharma Water Supply Systems
Step-by-step through the whole qualification process of water treatment systems including sample documents for all stages!

NEW ++ NEW ++ NEW

 
 
Principles of Equipment Qualification
Excerpt from the GMP Compliance Adviser

A Guide for Drug and Device Manufacturers - learn more about the four phases of qualification.

 
 
 
Sterile Manufacturing: Barrier Systems, Isolator and Safety Cabinets
With this clear and concise guide learn all about isolators and how they are used, about regulatory requirements, RABS and safey cabinets.

 
 
Classes and Grades for Air Cleanliness
This guide will tell you how to best implement GMP requirements on cleanrooms.

 
 
The Ultimate Checklist for Premises and HVAC Qualification
Do you know which regulatory and normative provisions are to be observed? Are you using checklists for the systematic handling of qualification activities?
Here is what you need: a pdf download providing you with all you need to know about qualification of premises.

 
 
A Successful Concept for Technology Transfer in Drug Manufacturing
This download covers all aspects you have to consider when transferring - including an example of a transfer plan you can directly work with!

 
 
Monitoring of HVAC Systems in GMP Environments
In this pdf download you'll find all important aspects regarding pharma monitoring of HVAC systems.

 
 
Environmental and Microbiological Monitoring at Drug Manufacturing Sites
This report provides everything you need to know to successfully monitor, investigate and mitigate contamination risks at drug manufacturing plants.

 
 
 
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