17/18 February 2021
In our GMP News dated 24 June 2020, we had reported about a WHO draft guideline on the topic of limit values in cleaning validation. The document had the rather bulky title "Points to consider on the different approaches - including HBEL - to establish carryover limits in cleaning validation for identification of contamination risks when manufacturing in shared facilities". This draft has now been significantly revised and re-issued with a new title "Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation". What changes have been made?
The document is slightly shorter than the previous document (21 pages) with 20 pages.
The chapters are nearly the same, but the traditional approach has been changed to a historical approach. However, a lot has changed in the document itself. Nearly every passage has been revised, many things have been clarified, and some sentences have just been rearranged. The topic of risk assessment has consistently been given a higher priority. The glossary has significantly increased in volume. The chapters "Technical and Organisational Controls" and "Grouping" have been removed. A separate Annex 1, with 2 pages, provides guidance on the use of Health-Bases Exposure Limits (HBELs) for risk assessment in the context of cleaning validation.
The guideline shall be posted on the WHO website under "current projects" for comment until 21 September 2020.