Certificate of Analysis

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The Certificate of Analysis (CoA) ( English for. : Certificate of Analysis ) is common in the pharmaceutical that in drug production used and produced -Umfeld as a document showing batches meet the necessary requirements ( "specification"). Certificates of analysis are issued for raw materials ( drugs , pharmaceutical auxiliaries , packaging materials ) as well as for drugs. The specification defines essential quality characteristics, such as proof of identity, content, permissible impurities, physical and pharmaceutical-technical characteristics. Many quality features are in pharmacopoeias Are defined.

Document EMA / INS / MRA / 387218/2011 Rev 5 of the European Medicines Agency is in general use for issuing a Certificate of Analysis for medicinal products for human use; Documents based on this standard are generally accepted worldwide.

Individual evidence

  1. http://ec.europa.eu/health/files/eudralex/vol-4/mra_batch-certificate_05-2011.pdf Internationally harmonized requirements for batch certification , accessed March 3, 2014