News about GMP/cGMP

29.05.2020

WHO publishes Technical Report Series No. 1025, 2020

The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets annually and their reports (Technical Report Series) include all adopted guidelines in form of Annexes.

With the publication of the 54th Technical Report Series No. 1025 of the WHO, several new and revised Guidelines were adopted and recommended for use.

 

In the area of „Quality Assurance – GMP” these are:

  • Production of water for injection by means other than distillation (Annex 3)
    The Expert Committee noted that the document should be integrated into WHO’s existing guideline on Water for pharmaceutical use.
  • Good chromatography practices (Annex 4)
  • Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance (Annex 6)

In the area „Quality Assurance – distribution and supply chain“ the following two documents were adopted:

  • Good storage and distribution practices for medical products (Annex 7)
  • Points to consider for setting the remaining shelf-life medical products upon delivery (Annex 8)

Clicking here takes you directly to TRS 1025, that summarises and interprets all results of the 54th WHO-Expert-Meeting of October 2019 in Geneva. The final guidelines are listed in form of annexes and will be published on the WHO website as single documents shortly.


Source:

WHO: Specifications for Pharmaceutical Preparations



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