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GMP Manufacturing

Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing
The draft of Annex 1 of the EU GMP Guidelines keeps numerous responsible persons in the pharmaceutical industry busy. Are you already prepared for the possible changes?
Based on a comparison with the currently valid version this download demonstrates where action is needed.

NEW ++ NEW ++ NEW

 
 
EU-Compliant Batch Release of Medicinal Products
How to Meet the GMP Requirements of Annex 16 EU GMP Guide

Batch release is complex and challeging due to requirements, responsibilities and the global product flow. Make sure to safely circumvent the multiple pitfalls that lie in wait – Order now!

NEW ++ NEW ++ NEW

 
 
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!

 
 
Creating a Master Plan for Drug Warehousing, Transportation and Distribution
This pdf download is the ultimate guide to preparing your company for compliance with GDP. Step by step, it walks you through the planning and implementation process, including the six key requirements included in the EU GDP Guidelines!

 
 
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 pdf download leads you step by step through the 4 key processes in microbiological monitoring.
Additionally you will get a detailed look at monitoring and testing in 3 critical areas: surfaces, personnel and air.

 
 
A Successful Concept for Technology Transfer in Drug Manufacturing
This download covers all aspects you have to consider when transferring!

incl. an example of a transfer plan you can directly work with

 
 
Classes and Grades for Air Cleanliness
This pdf download provides you with the tools you need to achieve compliance with the limits for airborne particles and microorganisms. Learn all you need to know about GMP requirements for cleanroom premises!

 
 
Sterile Manufacturing: Barrier Systems, Isolator and Safety Cabinets
What safety features for product and personnel protection do isolators provide? What regulatory requirements must be met?

With this clear and concise guide you will get answered to these and other frequently asked questions!

 
 
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.

 
 
 
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