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GMP Manufacturing

Managing Contract Manufacturers and Testing Labs
A comprehensive step-by-step guide, which covers all aspects of selecting and managing contractors.

 
 
 
Microbiological Monitoring in Pharmaceutical Manufacturing
A Guide to Control Microbial Risks in Sterile and Aseptic Drug Manufacturing

 
 
GMP-Questionnaire: Contract Manufacturing / Contract Analysis
SOP "GMP-Questionnaire: Contract Manufacturing / Contract Analysis"
Standard draft to adapt and extend

 
 
GDP Audit Questionnaire
for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices

NEW: now also for active substances and modifiable!

More than 700 questions with references to GMP/GDP regulations and EN ISO 13485 on the preparation and implementation of Good Distribution Practice (GDP) audits

Your perfect working tool: compact and practice-oriented!

NEW ++ NEW ++ NEW

 
 
Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to prepare a company for compliance with Good Distribution Practice (GDP)

 
 
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

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

 
 
Environmental and Microbiological Monitoring at Drug Manufacturing Sites
This report provides everything you need to know to successfully monitor, investigate and mitigate contamination risks at drug manufacturing plants.

 
 
A Successful Concept for Technology Transfer in Drug Manufacturing
This download covers all aspects you have to consider when transferring - including an example of a transfer plan you can directly work with!

 
 
Classes and Grades for Air Cleanliness
This guide will tell you how to best implement GMP requirements on cleanrooms.

 
 
Sterile Manufacturing: Barrier Systems, Isolator and Safety Cabinets
With this clear and concise guide learn all about isolators and how they are used, about regulatory requirements, RABS and safey cabinets.

 
 
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.

 
 
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.

 
 
 
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