WHO revises Guideline for Maximum Hold Times
Recommendation
Thursday, 12 February 2026 9 .00 - 17.00 h
Best Practice for Manual and Automated Visual Inspection of Parenterals
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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
04.02.2026Endotoxins Testing: Potential Change for WFI and Steam in the USP
04.02.2026Microbiological Deviations and Technical Deficiencies - Warning Letter to US Manufacturer
28.01.2026Changes to the 'Water Monographs' in the European Pharmacopoeia
21.01.2026Deficient Water System: Warning Letter to US Manufacturer
17.12.2025FDA publishes new Draft Guideline on GMP for Medical Gases
10.12.2025VDI 6022 Sheet 8.1 published: Qualification for the cleaning of air-conditioning systems