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India and China top 2013's GMP failures, according to EMA data

By Dan Stanton

- Last updated on GMT

Related tags: Quality control

EMA has made GMP non-compliance data available to public
EMA has made GMP non-compliance data available to public
The European Medicines Agency (EMA) has published for the first time details of manufacturers who have violated GMP as part of its transparency initiative.

Late last month, the agency updated the public version of the EudraGMDP database - a community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates - to include the publication of statements of non-compliance with GMP.

According to spokesperson Sophie Labbé, documents of non-compliance are issued to manufacturers following an inspection of a facility that is not deemed GMP compliant.

“What is new is that these non-compliance documents are now publicly accessible,”​ Labbé told in-Pharmatechnologist.com. “The Agency has taken this new initiative as part of its general goal to increase transparency and openness of its operations.”

So far the database goes back to 2007 and includes over 80 non-compliance reports. In 2013 alone there were 34 cases of facilities failing on GMP compliance, effecting sterile, non-sterile and API manufacturing and stemming from issues including quality control testing, packaging as well as the production of the product itself.

Geographically speaking, there were no real surprises with the majority of plants in breach of GMP based in China and India (10 and 14 respectively).

Some of these problems - such as Wockhardt’s Waluj, India facilities​, and the Suzhou No. 4 Pharmaceutical Factory, China​ - were reported at the time by in-Pharmatechnologist.com but for the others we present to you below a map of geographical location and a link to the EMA’s statement of non-compliance. Click the link to 'fly' to the facility of interest. (For viewing on a mobile, please revert to desktop mode)

Since this article has been published, EudraGMDP has changed its URLs for its certificates of non-compliance. Please click here​ to access the database of non-compliance certificates directly.

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