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New Releases

Qualification of Pharma Water Supply Systems
Step-by-step through the whole qualification process of water treatment systems including sample documents for all stages!

NEW ++ NEW ++ NEW

 
 
Inspection of Process Validation
Do your validation processes meet their specified requirements?

This bilingual guide offers an excellent up-to-date approach on process validation. It facilitates the planning and execution of all necessary steps to be compliant.

NEW ++ NEW ++ NEW

 
 
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

 
 
A Pharma Guide to Cleaning Validation
This report offers you practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.

NEW ++ NEW ++ NEW

 
 
Qualification and Validation: Agency Expectations
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

 
 
Data Integrity in the EU
Excerpt from the GMP Compliance Adviser

Requirements for Quality Management Systems - learn more about the principles of data integrity, systems to monitor data integrity and the storage and archiving of records.

NEW ++ NEW ++ NEW

 
 
 
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