WHO revises Guideline for Maximum Hold Times
Recommendation
14-16 October 2025
GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms
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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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