South Africa's SAHPRA updates its GMP guideline to version 10

By ZY Cleanroom · Updated 2026-04-24 · Sources at the end of the page

What changed

The document is 34 pages long. Version 10 replaces version 9 of November 2025, which aligned the guideline with PIC/S Annex 16. The new item is Section 4.1.6. It sets the minimum experience that key personnel need for each licence category under Section 22C(1)(b) of the Medicines and Related Substances Act of 1965. The guideline is valid for five years from the effective date.

Points that reach sterile and cleanroom work

Source for the points below is SAHPRA guideline version 10. Section 2.1 says SAHPRA has adopted the PIC/S Guide to GMP and its later changes, and that manufacturers, importers and exporters must meet it.

For sterile products, Section 4.1.6.1 says the Responsible Pharmacist must show in-depth knowledge of Annex 1 of the PIC/S guide, edition PE 009-17. The list includes cleanroom behaviours, environmental monitoring, media fills and contamination control strategies. Section 4.1.5 says staff who work where contamination is a hazard, such as clean areas, need specific training.

Section 3.2 sets conditions for relying on another regulator's approval of a site. The approval must come from a recognised regulator within the previous three years. It must cover the same dosage form group, product type and activities. The text adds that meeting these conditions does not oblige SAHPRA to accept a site.

What a facility owner should check next

If you hold or seek a South African licence, check which guideline version your quality system cites. Compare your contamination control strategy, your environmental monitoring records and your clean-area training with Sections 4.1.5 and 4.1.6.1. The guideline names PE 009-17, and PIC/S has since published a newer edition of its guide, so check the current one.

Gowning rooms and airlocks affect how well staff can follow clean-area rules. Look at them on your drawings. If you are planning a cleanroom, you can send ZY Cleanroom your room list.

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Sources

• SAHPRA, SA Guide to Good Manufacturing Practice for Medicines, version 10, updated 24 April 2026
• SAHPRA Guidelines for Good Manufacturing Practice of Medicines, SAHPGL-INSP-02 v10, 13 April 2026 (PDF copy hosted by Spotlight NSP)