Saudi SFDA GMP Guide 4.4 splits Annex 2 and adds Annex 2A for ATMPs

By ZY Cleanroom · Updated 2026-05-21 · Sources at the end of the page

What changed

The guide's document-control table shows version 4.3 dated 29 November 2023 and version 4.4 dated 21 May 2026, both issued by the SFDA Operations Sector. The PDF runs to 460 pages. Its cover page still shows the original 2011 publication date, so cite the table date.

Annex 2A says it applies to investigational and authorised ATMPs. It can also be used in hospital manufacturing and compassionate use programmes where national law allows.

Room design points in Annex 2A

The source is SFDA GMP Guide version 4.4, Annex 2A, chapter 3 on premises. The text sets out these points.

Cross-contamination must be prevented by design and operation, and measures should match the risk. Some products, such as viruses, may need dedicated premises and equipment. More than one closed isolator may share a room if the risks are controlled. If isolators process different viral vectors in one room, the room and the facility need 100 percent air exhaustion, with no recirculation.

Air handling units should be built to limit cross-contamination between areas and may need to serve one area only. Single-pass air should be considered. Positive pressure is expected for sterile processing. Negative pressure is acceptable where pathogens are exposed, but that area should sit inside a positive pressure clean zone of suitable grade. Pressure cascades should be defined and monitored continuously, with alarms as set by Annex 1.

What a facility owner should check next

First, decide whether your product counts as an ATMP under the annex glossary. Then compare your air handling layout, isolator positions and pressure cascade with the points above. Check that your contamination control strategy explains each choice.

The guide's own cover asks readers to visit the SFDA website for the latest update. Check there before you fix a design. If you are planning a cleanroom, you can send ZY Cleanroom your room list.

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• Upgrading an existing cleanroom for EU GMP Annex 1: gap list
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• Turnkey cleanroom contractor
• Room list builder

Sources

• SFDA Guide to GMP for Medicinal Products, version 4.4 (PDF)