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GMP-Newsletter: LOGFILE

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Good Manufacturing Practice & Implementation

GMP Compliance Adviser
Online Single Licences
The Online Single Licences allow access to the database for one named user. Choose between:
  • monthly subscription
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regularly updated

 
 
GMP Compliance Adviser
Online Corporate Licence
With the Corporate Licence all employees of your company will have access to the GMP Compliance Adviser Online. Everybody does work with one source. Available as:
  • Subscriber licence (long-term) licence
regularly updated

 
 
GMP Fundamentals – A Step-by-Step Guide
Get a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) now!

 
 
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.

NEW: Now modifiable!

 
 
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

 
 
Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing
The draft of Annex 1 of the EU GMP Guidelines keeps many 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!

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

 
 
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.

 
 
Data Integrity in the EU
Requirements for Quality Management Systems

Excerpt from the GMP Compliance Adviser

 
 
Principles of Equipment Qualification
Excerpt from the GMP Compliance Adviser

A Guide for Drug and Device Manufacturers - learn more about the four phases of qualification.

 
 
Top Ten Data Integrity Traps
How to Find and Fix Problems

A FDAnews publication

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

 
 
 
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