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GMP Series - Downloads

10 to 60 pages with a price range from $ 99 to $ 135 provide
everything you must know about these specific GMP topics.

Available as pdf downloads – excerpts from the GMP Compliance Adviser

Qualification and Validation: Agency Expectations
This report is a "must have" guidance for all those who are involved in qualification and validation: It provides information about regulatory requirements, risk management, life cycle concepts and much more.

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.

 
 
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.

 
 
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.

 
 
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.

 
 
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.

 
 
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!

 
 
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

 
 
The Ultimate Checklist for Premises and HVAC Qualification
Do you know which regulatory and normative provisions are to be observed? Are you using checklists for the systematic handling of qualification activities?
Here is what you need: a pdf download providing you with all you need to know about qualification of premises.

 
 
Managing GMP Requirements in Biotech API Manufacturing
Are you familiar with all the different types of substances and their specific GMP regulations? If not, this download is the ultimate and comprehensive guide for you.

 
 
Industry Guide to handle OOX Test Results
What is the GMP-compliant approach and what do the single steps in the process flow look like? Our new pdf download picks up these questions and gives a concise overview of the OOX process.

 
 
 
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