Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products.

Biologicals : Journal of the International Association of Biological Standardization
Dianliang LeiSabine Kopp

Abstract

The innocuity test was indicated as a quality control test to release pharmaceutical and biological products to the market. The test was intended to detect possible extraneous toxic contaminants derived from the manufacturing processes of the product. The test was included in WHO Recommendations and Guidelines for vaccines, biotherapeutics and blood products and in some monographs on antibiotics in The International Pharmacopoeia. Over the past years, the requirements in WHO Recommendations/Guidelines for conducting the test evolved such that it could be waived for routine release of product once consistency of production was established to the satisfaction of the NRA, or that the need for this test should be discussed and agreed with the NRA. However, some users of WHO written standards for biologicals (i.e., Recommendations, Guidelines) and WHO specifications for pharmaceuticals (i.e., The International Pharmacopoeia) requested that the innocuity test be deleted from WHO written standards based on its lack of specificity and scientific relevance. In response to that request, we studied the history of this test and its use by the member states of WHO, and the recommendations in WHO written standards. The outcomes of the study ...Continue Reading

Citations

Oct 13, 2020·Biologicals : Journal of the International Association of Biological Standardization·Arnoud AkkermansJim Webster
Jul 27, 2021·International Journal of Pharmaceutics·Patricia Diez-EchaveAntonio Abel Lozano-Pérez

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