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WHO publishes points to consider in continuous pharmaceutical manufacturing
On 9 June 2026, WHO published Technical Report Series No. 1067, the fifty-ninth report of its Expert Committee on Specifications for Pharmaceutical Preparations. The committee met in October 2025. Annex 2 of the report is a 14-page text, WHO points to consider in continuous manufacturing of pharmaceutical products.
By ZY Cleanroom · Updated · Sources at the end of the page
What the annex covers
The text is for makers of active ingredients and finished products. Its examples focus on oral solid dosage forms. WHO says the principles may also apply to other dosage forms, biologicals and vaccines. The annex says it should be read with the ICH Q13 guideline and WHO good manufacturing practices.
It defines continuous manufacturing as a process where input materials are fed in and output materials are removed without a stop, across two or more integrated unit operations.
Points that reach facility planning
Source for the points below is Annex 2 of TRS 1067. The annex says premises and equipment should be appropriate to support continuous manufacturing. It asks manufacturers to consider systems for start-up and shutdown, sampling, process validation and continued verification, staff training, and cleaning and cleaning validation.
A risk assessment should cover at least the sourcing and control of material, equipment, processing steps and cleaning. WHO also lists a lack of commercially available equipment for small-scale continuous lines as a challenge. The annex gives no room classes, air change rates or layouts.
What a facility owner should check next
If you plan a continuous line, ask your process team which steps will be linked and how material, people and waste will move between them. Check that your risk assessment names cleaning and the diversion of non-conforming material.
The annex is guidance. It is not a law. Ask your regulator whether it applies the WHO text. If you are planning a cleanroom, you can send ZY Cleanroom your room list.
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