• 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

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

 
 
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.

 
 
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 a LDMS.

 
 
Essentials of Technical Documentation for Drug Manufacturing
This report will walk you through requirements and their practical, GMP-compliant implementation, including documentation checklists for the mechanical part of a facility as well as for the electrical and control element.

NEW ++ NEW ++ NEW

 
 
Electronic Batch Recording for Drugmakers
Introducing and implementing an EBR system requires systematic analysis, definition and assessment of the regulatory requirements, process-based data and product-relevant information. Electronic Batch Recording for Drugmakers gives you the necessary tools and knowledge for a successful introduction and implementation.

NEW ++ NEW ++ NEW

 
 
Successful Implementation of Electronic Document Management Systems
Various different aspects must be considered in order to transfer documentation management, including knowledge and information management, from a paper-based system into an electronic IT system. Our management report on Electronic Document Management Systems offers a sensible approach for planning and implementing a document management system.

NEW ++ NEW ++ NEW

 
 
 
Page 1/1    1