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Quality Management

A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

This ebook walks you step by step through the processes and procedures you’ll need to put in place. You’ll learn how to restructure your quality systems to satisfy GMP.

 
 
The Drug Manufacturer‘s Guide to Site Master Files
Instructions for preparing a Site Master File according to
PIC/S PE 008-4

Without an up-to-date Site Master File, you are not authorized to market pharmaceuticals to European customers.

 
 
Pharma Change Control
Strategies for Successful Company-Wide Implementation

Every page offers practical strategies to implement a company-wide change control program and meet FDA regulatory requirements.

 
 
Medical Devices
GMP requirements for medical devices

 
 
Quality Agreement
Quality Agreement
Standard draft to adapt and extend

NEW ++ NEW ++ NEW

 
 
Technical Agreement and Delimination of Pharmaceutical Responsibilities
Technical Agreement and Delimination of Pharmaceutical Responsibilities
Standard draft to adapt and extend

NEW ++ NEW ++ NEW

 
 
GMP-Questionnaire: Contract manufacturing / Contract analysis
GMP-Questionnaire: Contract manufacturing / Contract analysis
Standard draft to adapt and extend

NEW ++ NEW ++ NEW

 
 
GMP Supplier Assessment Questionnaire
GMP Supplier Assessment Questionnaire for Active Pharmaceutical Ingredients (API) and Expipients
Standard draft to adapt and extend

NEW ++ NEW ++ NEW

 
 
 
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