The European Compliance Academy released version 10.0 of the GMP Guideline Manager Software. The single user version is free of charge for individual members, company members receive a Multi-User Version. The software is a key benefit for ECA Members.

Similar to the versions of the GMP Navigator before, the unique CD-ROM contains a database of the worldwide GMP regulations issued by the most important medicines authorities and organisations worldwide – like FDA, EU, ICH, GHTF, PIC/S. An easy-to-use navigation system allows users to open the "library of guidances".

With the GMP Guideline Manager finding answers is quick and easy. The CD provides comprehensive information on guidelines and regulations containing statements on water for injection, cleaning validation, stability testing – or on any other GMP topic you are interested in. A comfortable search function allows users to browse the several thousand of pages of regulations by key words and to directly retrieve guidelines and guidances they are specifically interested in.

The CD-ROM also holds an archive with the FDA Warning Letters from the past three years, allowing users to search for frequently observed deficiencies. Moreover, in addition to FDA summaries and presentations, industry recommendations have also been added.

The annually updated GMP Guideline Manager cannot be purchased. It is only available free of charge to members of the European Compliance Academy: Members can also access the Guideline Manager online version on ECA's website at www.gmp-compliance.org which additionally comprises a "Guideline Tree sorted by topics".

Author:
Oliver Schmidt
on behalf of the European Compliance Academy (ECA)

*The GMP Guideline Manager CD version 10.0 was developed by Concept Heidelberg on behalf of the European Compliance Academy.