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Quality Management

Quality Agreement
This sample document defines framework conditions and processes between contract givers and contract acceptors in order to meet the mandatory quality criteria.

 
 
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.

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


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

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

 
 
Medical Devices
GMP requirements for medical devices

 
 
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.

 
 
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.

 
 
 
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