On Dec 22, 2022,WHO releasesWHO Technical Report Series 1044.It works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools.
The following new guidance texts were adopted and recommended for use:
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Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations;
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Points to consider when including Health Based Exposure Limits (HBELs) in cleaning validation;
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Good manufacturing practices: water for pharmaceutical use;
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Guideline on data integrity;
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WHO/United Nations Population Fund recommendations for condom storage and shipping temperatures;
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WHO/United Nations Population Fund guidance on testing of male latex condoms;
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WHO/United Nations Population Fund guidance on conducting post-market surveillance of condoms;
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WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms;
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WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce;
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Good reliance practices in the regulation of medical products: high-level principles and considerations;
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Good regulatory practices in the regulations of medical products.
You can click the original article to learn more: WHO Technical Report Series 1044
*This news is from WHO.
