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Quality Management

Managing Outsourced GMP Activities Successfully
This download shows you procedures you can implement now that ensure the successful management of your outsourced GMP activities.

 
 
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

 
 
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.

 
 
Roadmap to Manage Personnel in Pharmaceutical Manufacturing
The deployment of human resources must be carefully planned and organised. In order to assist you in successful human resource management and training, we have compiled this detailed roadmap.

NEW ++ NEW ++ NEW

 
 
How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment
This pdf download shows how you can establish an effective CAPA system, which interfaces there are to other systems and what content a CAPA SOP should have.

NEW ++ NEW ++ NEW

 
 
Implementing a World Class Deviation Management
In this pdf download you'll find answers on how deviations are defined, what must be observed in handling deviations, who is responsible for managing deviations and what interfaces to other systems there are.

 
 
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 an LDMS.

 
 
 
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