WHO TRS 1033 published in March 2021

WHO TRS 1033 published in March 2021 can be downloaded from the provided link

It includes 11 newly approved Annexes

The most important of which are:

1- WHO Annex 2 (TRS 1033): Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation

  • WHO Appendix 1 (included in Annex 2):
    Calculations of Health-Based Exposure Limits (HBELs) to assess risk in cleaning validation

2- WHO Annex 3 (TRS 1033): Good manufacturing practices: water for pharmaceutical use

3- WHO Annex 4 (TRS 1033): Guideline on data integrity

The following is a list of the 11 new Annexes:

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