WHO revises Guideline for Maximum Hold Times
Recommendation
25/26 November 2025
Nitrogen, Compressed Air, Pure Steam
Register now for ECA's GMP Newsletter
Already in spring 2013 the WHO had published a draft of a guideline for comments. This guideline lays down maximum hold times (we reported) for starting materials, intermediates and bulk products.
The WHO has now issued a revised version of the draft. The deadline for comments was extended from originally April to September.
The new draft of the WHO guideline as well as the forms for comments can be found in the members' area of the ECA website. To download, you have to be a registered ECA member (see here for the membership opportunities in case you are not yet member).
Related GMP News
05.11.2025ECA revises Container-/Closure-Integrity Testing (CCIT) Position Paper
05.11.2025Ozone Concentration during the Sanitization of PW and WFI Systems
29.10.2025Is Surface Roughness in Pure Steam Systems relevant to GMP?
01.10.2025Different Sanitation Strategies for Sections of a WFI Systems?
24.09.2025Warning Letter due to Particles in Infusion Bags
24.09.2025New USP Chapter on oral Dosage Forms