WHO revises Guideline for Maximum Hold Times

Recommendation
16-18 September 2025
Barcelona, Spain
Organisation of a GMP-compliant Site Change
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).
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