GMP News No. 553
11 May 2005
New Version 7.0 of the CD-ROM GMP Navigator Has Been Released
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 7.0 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 7.0. 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 ECA/CONCEPT HEIDELBERG events, 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 at www.gmp-compliance.org.
If you would like to read more about the CD-ROM GMP Navigator, click here.