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GMP Series - Downloads

10 to 50 pages with a price range from $ 25 to $ 80 provide
everything you must know about these specific GMP topics.

Available as pdf downloads – excerpts from the GMP Compliance Adviser

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.

 
 
The Ultimate Particle Monitoring Guide
The Ultimate Particle Monitoring Guide will help readers to perform GMP-compliant particle monitoring by covering all relevant regulatory, technical and operational issues.

 
 
Approved Pharmaceutical Water Qualities
The report will walk you in detail through the requirements for the four water types that are of particular importance for pharmaceutical manufacturing.

 
 
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.

 
 
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.

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

 
 
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.

 
 
GMP Compliance Basics of Packaging Materials and Processes
With this management report, you'll get step-by-step guidance through all you need to know about packaging materials and the packaging process.

 
 
Reliable and Recommended Materials for GMP-Compliant Equipment
With this pdf download you get a clear, concise guide. You'll find all you need to know about the GMP requirements applying to construction materials.

 
 
Applying the Principles of Hygienic Design to Solid Dosage Forms
This pdf download explains all important design characteristics for hygienic design, using the example of different types of connections, feeding and dosing systems, and cleanroom installations.

 
 
Technical Solutions for Personnel Protection in Solid Drug Manufacturing
To avoid short-term or long-term damage to the health of personnel, it is especially important to contain the product where it is manufactured. This download will tell you how to best put containment (personal protection) into practice.

 
 
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.

 
 
Monitoring of HVAC Systems in GMP Environments
In this pdf download you'll find all important aspects regarding pharma monitoring of HVAC systems.

 
 
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!

 
 
 
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