Chapter 7 Quality Assurance – Good Manufacturing Practices of the report sums up all updates in the area of GMP. The main focus lies on the guidance on validation and its appendices:
A complete guidance package on validation including all appendices and cross- references can be expected by the end oft he year.
Furthermore, a concept paper on the preparation of new guidance on good practices for desk review is in progress. As there is no general guidance on this topic the Committee recommended proceeding with its development. The intention is to make the best possible use of available resources and existing information on compliance of sites with relevant good practices (GXP) by relying, where appropriate, on desk review of inspectional information from reliable and trusted sources rather than conducting on-site inspections. Such reliance is currently practised, for example, by PQT–Inspections and the Therapeutic Goods Administration of Australia.
WHO: TRS 1003, July 2017
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