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 were reviewed by the relevant WHO Expert Committee on Biological Standardization and Expert Committee on Specifications for Pharmaceutical Products who then decided to discontinue this test in WHO Recommendations for vaccines and biologicals and to omit the test from The International Pharmacopoeia.

无毒测试被认为是将药物和生物产品投放市场的质量控制测试。该测试旨在检测源自产品制造过程的可能的外来有毒污染物。该试验已包括在WHO关于疫苗，生物治疗剂和血液制品的建议和指南中以及《国际药典》中有关抗生素的一些专着中。在过去的几年中，世卫组织建议书/指南中进行测试的要求不断发展，以便一旦建立了生产一致性达到NRA满意的水平，或者可以满足该测试的需求，则可以免除产品的常规发布与NRA讨论并达成协议。但是，某些WHO生物学书面标准（即建议，指南）和WHO药品规范（即国际药典）的用户）基于无特异性和科学意义，要求从世界卫生组织的书面标准中删除无罪检测。为了响应该要求，我们研究了该测试的历史及其在世卫组织成员国中的使用，以及世卫组织书面标准中的建议。世卫组织有关生物标准化的专家委员会和药品规格专家委员会对研究结果进行了审查，然后决定中止世卫组织关于疫苗和生物制剂的建议中的此项试验，并从国际药典中删除该试验。