Indian and Chinese API Manufacturers in the Focus of European Authorities

The EudraGMP database was originally launched in April 2007 and is used to exchange information on compliance with the Good Manufacturing Practices (GMP) between the relevant regulatory authorities of the EU Member States - including Iceland, Liechtenstein and Norway. Since January 2011 the data of all national authorities can be accessed. Further, since April 2013 the database also contains information about GDP, why it is referred to as Eudra GMDP database now.
 
The database comprising the reports about deficiencies found in inspections by the European authorities - the "non-compliance reports" or, officially, "statement of non-compliance with GMP" - was extended by three reports last week: two of these reports related to Chinese firms, one report to a company in India. The inspections were conducted by inspectors of the Italian authority.
 
The inspection of the Indian site (antibiotic APIs) revealed that samples, materials and documents were stored improperly. The falsification of data and documents was found. At one of the two Chinese manufacturers who also produces an antibiotic API, inspectors were also not allowed to access an apparently uncontrolled storage area of raw material and finished products - which they estimated as high risk in terms of data falsification. In the second inspected Chinese manufacturing facility (sterile active ingredient manufacture) inspectors objected to especially high risks with regard to contamination (inadequate clothing of workers, no monitoring of the differential pressure between spaces of different purity classes, no precautions to avoid contamination during the transfer of the sterile active substance between different containers etc.).
 
As a consequence of the inspection results, the competent authorities were prompted to check in all three cases whether the manufacturer must be removed from the relevant registration documents. In this case, the marketing authorisation holders have to look for alternative API suppliers. Furthermore, the regulatory authorities are urged not to approve new applications in which these manufacturers are listed. The corresponding CEPs for the Indian and for one of the Chinese manufacturers were suspended respectively withdrawn.
 
The Eudra GMDP database so far contains a total of 7 non-compliance reports on inspections at API manufacturers in China (3), India (2), United States (1) and the United Kingdom (1).

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