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See for yourself how GMP Compliance Adviser provides you with state-of-the art GMP know-how that will simplify your daily business!


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GMP-Newsletter: LOGFILE

Lesen Sie GMP-News und informative Beiträge zum Thema GMP in unserem kostenlosen 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
  • yearly subscription
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.
Your perfekt working tool: compact and practice-oriented!

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

 
 
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

 
 
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

 
 
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

 
 
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
Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP Guidelines?
This report offers you practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.

 
 
Qualification and Validation: Agency Expectations
A qualification serves to prove that equipment is fit for its given purpose. So far, so good. But what are the actual fundamental requirements for a successful equipment qualification and what are the core elements of qualification work?

 
 
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

 
 
 
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