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Quality Management

Failure Management in a GMP Regulated Environment
How can occured failures be avoided in the future? Start to treat the root cause, not the symptoms!

Learn how to set up a failure management system and how to use root cause analysis methods and tools correctly!

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

 
 
Data Integrity in the EU
Nowadays all regulatory authorities focus on data integrity and have their own data integrity guidelines - however, their regulations don’t always agree.
With this pdf download you will understand all the requirements! This report details the ins and outs of all three documents of EMA, MHRA and WHO and explains how the FDA regulations fit in.

 
 
Principles of Equipment Qualification
This pdf download lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ - that satisfies US and EU requirements.

incl. checklists for carrying out a qualification plan and instructive diagrams

 
 
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 mandatory quality criteria.

 
 
A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

This pdf download helps you bring your drug manufacturing quality systems into compliance!

The lifecycle process approach is an orderly and effective way of taming the quality system. Once you have mastered it, you will wonder why you waited.

 
 
GMP Supplier Assessment Questionnaire
GMP Supplier Assessment Questionnaire for Active Pharmaceutical Ingredients (API) and Excipients
Standard draft to adapt and expand

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

 
 
Technical Agreement and Delimitation of Pharmaceutical Responsibilities
SOP "Technical Agreement and Delimitation of Pharmaceutical Responsibilities"
Standard draft to adapt and extend

 
 
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.

 
 
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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