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Quality Unit

You are responsible for Good Manufacturing Practice (GMP).
We provide the essential information you need: GMP expert knowledge to base your decisions.

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!

 
 
Qualification and Calibration of Laboratory Instruments in Pharmaproduction
A number of different approaches can be taken when it comes to the qualification of analytical instruments. But which one should you take?
This pdf download will help you mastering all phases of qualification and calibration!

incl. form for a requalification report, samples of a qualification plan and report, sample calibration SOP

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

 
 
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

 
 
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

 
 
Qualification of Pharma Water Supply Systems
Step-by-step through the whole qualification process of water treatment systems including sample documents for all stages! The qualification of pharma water systems has never been so easy!

NEW ++ NEW ++ NEW

 
 
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

 
 
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.

 
 
 
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