Cleanroom contractor in Kenya: rules for buyers

By ZY Cleanroom · Updated 2026-11-01 · Sources at the end of the page

Which rules apply to your facility

Section 35A of the Pharmacy and Poisons Act, Cap. 244 (Revised Edition 2022), bars manufacture of a medicinal substance without a manufacturing licence. Licences expire on 31 December each year, and the premises are licensed on a prescribed application. Section 35B requires every licensee to comply with the good manufacturing practices the Board prescribes.

PPB's GMP Division inspects manufacturing sites, local and foreign, for marketing authorisation, runs risk-based inspection of local manufacturers, advises clients setting up sites and certifies sites as GMP-compliant or not. Its guidance includes the Kenya Good Manufacturing Practices Guideline and Guidelines for Establishing Manufacturing Facilities for Health Products and Technologies. PPB says it is aligning its GMP oversight with international standards, with WHO guidelines as a primary reference (PPB, GMP Division page, checked 1 November 2026).

Kenya is not on the PIC/S list of participating authorities (PIC/S, checked 1 November 2026).

Who builds cleanrooms here

Licensed medicine manufacturers are the regulated buyers. PPB says marketing authorisation is granted once the site of manufacture is confirmed to comply with GMP (PPB, GMP Division page).

What a foreign contractor must arrange

The National Construction Authority (NCA) treats a firm as foreign if it is incorporated outside Kenya, or in Kenya with 51% of shares held by a non-Kenyan. A foreign contractor registers with NCA after the award letter and before signing the contract, and the registration is specific to that contract. It must undertake to subcontract or form a joint venture with a local firm for not less than 30% of the contract value, transfer technical skills not available locally, and lodge an affidavit to wind up its Kenyan business after the defects liability period. NCA also says foreign contractors should only undertake works that fall in category NCA 1, its top value band (NCA public notice on foreign contractors; NCA Foreign Contractors page, checked 1 November 2026).

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. State whether the rooms are sterile or non-sterile, whether the plant is new or existing, and whether the owner already holds a PPB manufacturing licence. Name your NCA-registered local partner if you have one.

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.

Related guides

• Building a cleanroom inside an existing building
• How to audit a cleanroom panel factory, on site or by video
• How to Import a Cleanroom from China
• How long does it take to build a cleanroom?
• Turnkey cleanroom contractor
• Room list builder

Sources

• PIC/S, list of participating authorities (checked 1 November 2026)
• Laws of Kenya, Pharmacy and Poisons Act, Cap. 244, Revised Edition 2022 (sections 35A and 35B; WHO CPCD copy; checked 1 November 2026)
• Pharmacy and Poisons Board, Good Manufacturing Practices Division (checked 1 November 2026)
• National Construction Authority, Public notice: foreign contractors' provisions (checked 1 November 2026)
• National Construction Authority, Foreign Contractors (checked 1 November 2026)