For faster navigation, this Iframe is preloading the Wikiwand page for EudraGMP.

EudraGMP

EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. Access for the general public, via Internet, is available since 2009 using the URL : http://eudragmp.ema.europa.eu.

EudraGMP is part of the EU telematics strategy, which has been conceived in order to meet the strategic objectives of the European Commission, the European Medicines Agency and the Member State competent authorities.

EudraGMP is part of a larger database known as EudraGMDP, which contains information on:

  • “Manufacturing and import authorisations
  • Good manufacturing Practice (GMP) certificates
  • Statements of non-compliance with GMP
  • GMP inspection planning in third countries” [1]

The public database allows the general public access to information regarding manufacturing inspections completed by regulatory authorities from all European Economic Area (EEA) countries. Prior to the enactment of the EudraGMP database, information only came from a limited number of European countries. The European regulatory authorities update the database continuously and expect it to grow extensively over the next few years as more “GMP certificates are imported each year.” [2]

The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer. One can search by the “company name, location, or certificate number and find details on the types of products or activities that the company conducts and the date of the most recent GMP inspection.” [3]


See also

[edit]

References

[edit]
  1. ^ EudraGMP.EMA. 2007. Web November 13, 2013. http://eudragmdp.ema.europa.eu/
  2. ^ Robinson, Derek. “Regulatory Highlights from February – July 2011.” Organic Process Research & Development. (2011):15;970-973.
  3. ^ Robinson, Derek. “Regulatory Highlights for September 2009 to February 2010.” Organic Process Research & Development. (2010):14;323–327
[edit]
{{bottomLinkPreText}} {{bottomLinkText}}
EudraGMP
Listen to this article

This browser is not supported by Wikiwand :(
Wikiwand requires a browser with modern capabilities in order to provide you with the best reading experience.
Please download and use one of the following browsers:

This article was just edited, click to reload
This article has been deleted on Wikipedia (Why?)

Back to homepage

Please click Add in the dialog above
Please click Allow in the top-left corner,
then click Install Now in the dialog
Please click Open in the download dialog,
then click Install
Please click the "Downloads" icon in the Safari toolbar, open the first download in the list,
then click Install
{{::$root.activation.text}}

Install Wikiwand

Install on Chrome Install on Firefox
Don't forget to rate us

Tell your friends about Wikiwand!

Gmail Facebook Twitter Link

Enjoying Wikiwand?

Tell your friends and spread the love:
Share on Gmail Share on Facebook Share on Twitter Share on Buffer

Our magic isn't perfect

You can help our automatic cover photo selection by reporting an unsuitable photo.

This photo is visually disturbing This photo is not a good choice

Thank you for helping!


Your input will affect cover photo selection, along with input from other users.

X

Get ready for Wikiwand 2.0 🎉! the new version arrives on September 1st! Don't want to wait?