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GMP Subject Downloads

You are responsible for Good Manufacturing Practice (GMP). We provide the essential information you need:

  • GMP expert knowledge to base your decisions
  • Practical implementation support
  • Safety for your daily routine

These compilations of excerpts from the GMP MANUAL offer straightforward GMP information:

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

 
 
Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.
Each question with reference to the current EU GMP Guide Part I/II and the 21 CFRs 210/211/11.

For auditors and manufacturers of drugs and APIs.
Your perfekt working tool: compact and practice-oriented!

NEW: Now modifiable!

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

 
 
Managing Process Validation
A step-by-step guide based on real-world examination experience. Discover how to document process validation in a way that is sure to satisfy — and impress — regulators!

 
 
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!

 
 
Computer System Validation in the EU
Discover the tools you need to develop your trans-national validation program.
Use this step-by-step guide to implement a computer validation program that will satisfy U.S. and EU regulations!

 
 
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.

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

 
 
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.

 
 
 
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