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GMP Engineering

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.

NEW ++ NEW ++ NEW

 
 
 
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.

 
 
Applying the Principles of Hygienic Design to Solid Dosage Forms
This pdf download explains all important design characteristics for hygienic design, using the example of different types of connections, feeding and dosing systems, and cleanroom installations.

 
 
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.

 
 
Approved Pharmaceutical Water Qualities
The report will walk you in detail through the requirements for the four water types that are of particular importance for pharmaceutical manufacturing.

 
 
 
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