Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
(2002; 4 pages)


It has been recommended in various fora that WHO should establish a model certificate of analysis for use in trade in starting materials and by manufacturers of pharmaceutical substances, excipients and medicinal products. A model of such a certificate is shown in Appendix 1. The items included are based on good practices for national pharmaceutical control laboratories and good manufacturing practices (GMP) for pharmaceutical products (1). The certificate lists the results and includes a final evaluation and the conclusions of the examination of one or more samples.

In accordance with GMP, the certificate can be used in lieu of testing by the manufacturer (except for the identification tests as a minimum requirement), provided that the reliability of the supplier’s analysis is established by the periodic validation of the test results by appropriate means and, if feasible, by on-site audits of the supplier’s capabilities. Certificates must be originals (not copies or duplicates) or their authenticity must otherwise be assured, i.e. they must be issued by the supplier of the material concerned (manufacturer, broker, etc.), or based on the analytical worksheet of the laboratory testing the sample(s)...

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