The ECA has just finalized the development of version 14.0 of the GMP Guide Manager Software. This unique software is a service at no costs for ECA Members. The Software contains more than 1,100 GMP relevant Guidelines from FDA, EU, ICH, PIC/s, WHO and other organisations. The ECA will grant access to the online version at no costs for 4 weeks.
The software compiles only those guidelines that refer either to GMP topics or have an influence on GMP (e.g. Notice to Applicants). After starting the software, the table of contents appears. From here you can call up any of the guidelines. The GMP guidelines data base contains the complete texts. On your PC you can conduct quick research in the guidelines, a full-text search and even print out the texts. The guidelines are displayed in a well-structured Guideline Tree. With the new software solution the pdf files are now integrated in the navigation tree. The software also offers a comprehensive search engine. By this you can search in the complete database for keywords like "process validation" or "impurities". You also may search only in a certain category, e.g. only in FDA documents (note: this feature is not available for the online version).
The Software offers a "Guideline Tree" sorted by issuing authorities, and a second "Guideline Tree" sorted by topics. Users may use this Guideline Tree to find the applicable guideline, e.g. to “sterile manufacturing” or to “APIs”. Here you will find more information about the GMP Guideline Manager Software 14.0
Until February 28 the access to the online version is free. From February 28 on the online version will be only accessible to ECA Members via the members area. Participants of all ECA events will receive the CD as a single user version as part of the conference documentation. Companies who are ECA Company members receive a multi-user version for the internal IT network. Read more about ECA Membership opportunities here.
Please find the free access to the GMP Guideline Manager here: