In August 2020 the WHO published a third revision of the document Good regulatory practices for regulatory oversight of medical products containing 46 pages. The document is intended to reflect Member States with widely-recognized principles of Good Regulation Practice (GRP). The nine principles outlined are:
They are the result of a comprehensive review of public documents developed by governments and multilateral organisations and concern all authorities responsible for the regulatory oversight of medicinal products.
The document Good manufacturing practices: water for pharmaceutical use containing 30 pages was published in July 2020 as a second revised draft for the next round of public consultation. In short, the following changes were made:
The third document is the second draft revision of the Guideline on data integrity from June 2020 containing 29 pages. In its final version it will replace the WHO Guidance on good data and record management practices (Annex 5, WHO Technical Report Series, No 996, 2016) (1). The document has been harmonised with existing DI guidelines, e. g. the US FDA, as far as possible. In terms of content, the wheel might not be reinvented in this draft, but a clear structure and language speak for the document. The examples of quality risk management and data integrity assessments are well worth mentioning, as well as the ten examples of good documentation practices in data integrity.
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