• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Shopping cart
Your shopping cart is empty

Show shopping cart...
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

Qualification / Validation

A Pharma Guide to Cleaning Validation
This report offers you practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.

NEW ++ NEW ++ NEW

 
 
Qualification and Validation: Agency Expectations
A "must have" guidance for all those who are involved in qualification and validation: It provides information about regulatory requirements, risk management, life cycle concepts and much more.

NEW ++ NEW ++ NEW

 
 
Data Integrity in the EU
Excerpt from the GMP Compliance Adviser

Requirements for Quality Management Systems - learn more about the principles of data integrity, systems to monitor data integrity and the storage and archiving of records.

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.

NEW ++ NEW ++ NEW

 
 
How to design a Laboratory Data Management System
The introduction of a LDMS has an extremely positive impact on the efficiency and quality of the work in and around the analytical laboratory.
This new management report offers practical strategies for designing and implementing a LDMS.

 
 
Computer System Validation in the EU
Just when you think you’ve got the FDA’s requirements figured out, the EU issues its own. Do you know how they differ? Here you'll find a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations.

 
 
Managing Process Validation
A Drugmaker‘s Guide

Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.

 
 
 
Page 1/1    1