Country guide: South Africa
Cleanroom contractor in South Africa: rules for buyers
In South Africa the regulator approves the owner's facility, not the contractor: SAHPRA for medicine plants and the Office of Health Standards Compliance (OHSC) for hospitals and clinics. SAHPRA has been a PIC/S participating authority since July 2007.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your facility
SAHPRA's Guidelines for Good Manufacturing Practice of Medicines (SAHPGL-INSP-02, version 10, dated 13 April 2026) rest on the PIC/S GMP Guide. Version 2, effective January 2006, first adopted that guide. Version 9, effective November 2025, aligned the text with PIC/S Annex 16 (SAHPRA guideline, document history).
For sterile manufacturing, the guideline expects the Responsible Pharmacist of a manufacturing pharmacy to show in-depth working knowledge of Annex 1 of the PIC/S GMP Guide (PE 009-17), including environmental monitoring and contamination control. Experience rules for key personnel are set per licence category under Section 22C(1)(b) of the Medicines and Related Substances Act (SAHPRA guideline, version 10).
Hospitals and clinics fall under the Norms and Standards Regulations Applicable to Different Categories of Health Establishments, Government Notice 67 of 2 February 2018, made under the National Health Act 61 of 2003. The OHSC says they came into operation in 2019. It inspects and certifies health establishments and can issue compliance notices (Acts Online; OHSC bulletin; OHSC certification report).
| Facility | Regulator and rule |
|---|---|
| Medicine plant | SAHPRA, GMP Guidelines version 10, based on the PIC/S GMP Guide |
| Sterile products | PIC/S GMP Guide Annex 1 (PE 009-17), cited in the guideline |
| Hospital or clinic | OHSC, Norms and Standards Regulations, Government Notice 67 of 2018 |
Who builds cleanrooms here
The SAHPRA guideline sets personnel rules by licence category, including manufacturing pharmacies that make sterile products. Licence holders making sterile medicines are therefore the clearest buyers of cleanrooms. Public and private hospitals and clinics are the other group, because the OHSC inspects them against the national norms.
What to send for a first scope
Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. Say whether the rooms are for sterile products and whether SAHPRA, the OHSC or both will inspect. State the province and whether the building is new or existing. Give the PIC/S Annex 1 edition the owner's quality team works to.
Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. Certification and testing can be arranged per project.
Who does the site work
Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.
Questions
Common questions
Does SAHPRA approve cleanroom contractors?
No. SAHPRA licenses and inspects the owner's medicine plant. The owner chooses and manages the contractor.
Which GMP guide does SAHPRA use?
The PIC/S GMP Guide, first adopted in version 2 of the SAHPRA guideline, effective January 2006. Version 10 is dated 13 April 2026 (SAHPRA guideline).
Is SAHPRA a PIC/S member?
Yes. PIC/S lists SAHPRA with accession in July 2007 (PIC/S, checked 31 October 2026).
Who inspects hospitals in South Africa?
The OHSC inspects health establishments against the norms and standards in Government Notice 67 of 2018. It certifies them and can issue compliance notices (Acts Online; OHSC certification report).
Related guides
- How to Import a Cleanroom from China
- How to audit a cleanroom panel factory, on site or by video
- How to choose a cleanroom contractor: questions and evidence
- What a cleanroom costs to run: energy, filters and testing
- Turnkey cleanroom contractor
- Room list builder
Sources
- PIC/S, list of participating authorities (checked 31 October 2026)
- SAHPRA, SA Guide to Good Manufacturing Practice, SAHPGL-INSP-02 version 10 download page (updated 24 April 2026; checked 31 October 2026)
- SAHPRA, Guidelines for Good Manufacturing Practice of Medicines, SAHPGL-INSP-02 version 10, 13 April 2026 (copy hosted by Spotlight NSP; checked 31 October 2026)
- Acts Online, Norms and Standards Regulations Applicable to Different Categories of Health Establishments, Government Notice 67 of 2018 (checked 31 October 2026)
- OHSC, Bulletin Volume 6 (checked 31 October 2026)
- OHSC, Bi-Annual Certification Report 2019/20 (checked 31 October 2026)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184