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GMP Engineering

Failure Management in a GMP Regulated Environment
How can occured failures be avoided in the future? Start to treat the root cause, not the symptoms!

Learn how to set up a failure management system and how to use root cause analysis methods and tools correctly!

NEW ++ NEW ++ NEW

 
 
Qualification of Pharma Water Supply Systems
Step-by-step through the whole qualification process of water treatment systems including sample documents for all stages! The qualification of pharma water systems has never been so easy!

NEW ++ NEW ++ NEW

 
 
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

 
 
The New USP <1231>: Water for Pharmaceutical Purposes
What has changed compared to the last version? Are there new requirements that did not previously exist? Can some things be omitted in the future?

In this pdf download these and other frequently asked questions are answered while giving a compact overview of the contents of the completely revised chapter.

 
 
Sterile Manufacturing: Barrier Systems, Isolator and Safety Cabinets
What safety features for product and personnel protection do isolators provide? What regulatory requirements must be met?

With this clear and concise guide you will get answered to these and other frequently asked questions!

 
 
Classes and Grades for Air Cleanliness
This pdf download provides you with the tools you need to achieve compliance with the limits for airborne particles and microorganisms. Learn all you need to know about GMP requirements for cleanroom premises!

 
 
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 the qualification of premises.

 
 
A Successful Concept for Technology Transfer in Drug Manufacturing
This download covers all aspects you have to consider when transferring!

incl. an example of a transfer plan you can directly work with

 
 
Monitoring of HVAC Systems in GMP Environments
This pdf download explains all important aspects regarding pharma monitoring of HVAC systems, including physical and microbiological monitoring, as well as validation of the monitoring system in accordance with GAMP®5.

 
 
Environmental and Microbiological Monitoring at Drug Manufacturing Sites
This pdf download leads you step by step through the 4 key processes in microbiological monitoring.
Additionally you will get a detailed look at monitoring and testing in 3 critical areas: surfaces, personnel and air.

 
 
 
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