GMP News No. 690
16 March 2006
|New Version 8.0 of the CD-ROM GMP Navigator Released|
The CD Rom GMP Navigator 8.0* contains more than 800 GMP guidelines, e.g. from FDA, EU, ICH, GHTF, PIC/S. This unique GMP tool cannot be purchased. The CD-ROM is a free service provided to all participants who join one of the events organised by the European Compliance Academy (ECA) .The CD GMP Navigator is a yearly published CD with the current worldwide GMP regulations. An easy-to-use navigation system allows the user to open the "library of guidances".
Thousands of pages are easily accessible. The easy-to-handle search function will give immediate answers to the questions: Which guidances and regulations contain statements on water for injection, cleaning validation, stability testing or any other GMP topic you are searching for?
The new version 8.0 has been updated with the latest GMP regulations. Also all GMP-relevant FDA warning letters are included on the CD-ROM. This allows you to search for frequently observed deficiencies.
In addition to FDA summaries and presentations, industry recommendations have also been added on the latest update 8.0. E.g. the Active Pharmaceutical Ingredient Committee (APIC) has published several guidances on ICH Q7A compliance (e.g. ICH Q7A How to do, Cleaning Validation, Technical Change Control Guideline).
If you join one of the future events of the European Compliance Academy, the CD will be part of your conference documentation!
All ECA Members also have the opportunity to have access to the online database by visiting the Members Area on this webpage.
* The CD GMP Navigator 8.0 was developed by Concept Heidelberg on behalf of the European Compliance Academy.