22/23 April 2021
GMP News No. 905: New Version 9.0 of GMP Navigator Software Released under New Name
New Version 9.0 of GMP Navigator SoftwareReleased under New Name
Similar to the versions of the GMP Navigator before, the uniqueCD-ROM contains information on current worldwide GMP regulations issuedby the most important medicines authorities and organisations worldwide– like FDA, EU, ICH, GHTF, PIC/S. An easy-to-use navigation systemallows users to open the "library of guidances".
With the GMP Guideline Manager finding answers is quick and easy. TheCD provides comprehensive information on guidelines and regulationscontaining statements on water for injection, cleaning validation,stability testing – or on any other GMP topic you are interested in. Acomfortable search function allows users to browse the several thousandof pages of regulations by key words and to directly retrieve guidelinesand guidances they are specifically interested in.
The CD-ROM also holds an archive with the FDA Warning Letters fromthe past three years, allowing users to search for frequently observeddeficiencies. Moreover, in addition to FDA summaries and presentations,industry recommendations have also been added.
The annually updated GMP Guideline Manager cannot be purchased. It isonly available free of charge to members of the European ComplianceAcademy, who receive a copy every time they attend an ECA event. Memberscan also access the Guideline Manager online version on ECA's website atwww.gmp-compliance.org whichadditionally comprises a "Guideline Tree sorted by topics".
Membership can be acquired automatically through participating in oneof the European Compliance Academy courses or conferences (exception:Webinars). In addition, the Academy also offers two other membershipopportunities – individual membership and company membership.
*The GMP Guideline Manager CD version 9.0 was developed by ConceptHeidelberg on behalf of the European Compliance Academy.