Cleanroom contractor in Nigeria: rules for buyers

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

Which rules apply to your plant

NAFDAC's GMP for Pharmaceutical Products Guidelines 2024 (DER-GDL-019-03) took effect on 26 November 2024, with review due on 25 November 2029. NAFDAC says to read them with WHO GMP guidelines and other international texts such as PIC/S, ICH and EMA. For sterile products the guidelines refer to EU GMP Annex 1 (NAFDAC, GMP Guidelines 2024).

For a proposed factory, the owner applies to NAFDAC's Drug Evaluation and Research Directorate with an electronic layout showing man and material flow, room classifications and pressure differentials between adjoining areas. After the layout review, the owner submits a site master file, evidence of incorporation, the pharmacists' licences, a quality manual and a validation master plan. New production lines and changes to major utilities need NAFDAC approval later (NAFDAC, DER-GDL-008-02, effective 7 December 2024).

Medical devices have a separate guideline, DER-GDL-018-00, effective 11 November 2024. It covers devices made in Nigeria and exported to Nigeria, says premises are inspected against it and ISO 13485:2016, and asks for cleanroom monitoring with HEPA filters and air pressure differentials (NAFDAC, GMP for Medical Devices Guidelines 2024).

NAFDAC and the Pharmacists Council of Nigeria became PIC/S pre-applicants after an application received on 8 May 2025 (PIC/S, 30 September 2025). Nigeria is not yet on the PIC/S list of participating authorities.

Who builds cleanrooms here

NAFDAC's pharmaceutical guidelines apply to pharmaceutical, biological and veterinary products. The device guideline covers devices, IVDs and related products. Owners of those plants are the regulated buyers of cleanrooms.

What a foreign contractor must arrange

Under section 78 of the Companies and Allied Matters Act, a foreign company must incorporate a separate entity in Nigeria to carry on business. Section 80 lets a company in certain categories, such as one on a project approved by the Federal Government, apply to the Minister for an exemption, which names the period or project it covers (Gresyndale Legal, 8 April 2024). Settle with the owner which entity signs and holds the site works.

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 plant makes drugs or devices, whether the rooms are sterile or non-sterile, and whether the layout has gone to NAFDAC for review.

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

• How to Import a Cleanroom from China
• The Cleanroom Project Lifecycle
• How to choose a cleanroom contractor: questions and evidence
• Building a cleanroom inside an existing building
• Turnkey cleanroom contractor
• Room list builder

Sources

• PIC/S, list of participating authorities (checked 1 November 2026)
• PIC/S, Nigeria, Tanzania, Rwanda and Senegal become PIC/S Pre-Applicants (30 September 2025)
• NAFDAC, Guidelines for Pre-Production Inspection of Pharmaceutical Manufacturing Facilities in Nigeria, DER-GDL-008-02 (effective 7 December 2024)
• NAFDAC, GMP for Pharmaceutical Products Guidelines 2024, DER-GDL-019-03 (effective 26 November 2024)
• NAFDAC, GMP for Medical Devices, IVDs and Related Products Guidelines 2024, DER-GDL-018-00 (effective 11 November 2024)
• Gresyndale Legal, Can a foreign company do business in Nigeria without incorporation (8 April 2024)