Country guide: Philippines
Cleanroom contractor in the Philippines: rules for buyers
In the Philippines the regulator approves the owner's facility, not the contractor. The Food and Drug Administration (FDA) inspects drug plants against the PIC/S Guide to GMP, and the Department of Health (DOH) issues a Permit to Construct for new or substantially altered hospitals.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your facility
DOH Administrative Order 2012-0008 adopted the PIC/S Guide to GMP for medicinal products, and later PIC/S revisions are adopted after a transition (RAPS, 20 May 2024). FDA Advisory No. 2023-0258 imposed strict compliance with PE 009-14 from 15 January 2023 and told stakeholders to prepare for PE 009-16, with the date left to a separate advisory (FDA Philippines, Advisory 2023-0258). RAPS reported in May 2024 that the FDA extended conformity to PE 009-14 until 15 January 2025. Confirm the current edition with the FDA. The Philippines is not on the PIC/S list of participating authorities (PIC/S, checked 31 October 2026).
For hospitals, DOH Administrative Order 2016-0042 (adopted 14 December 2016, filed 5 January 2017) governs the Permit to Construct. The DOH-PTC is issued through the Health Facilities and Services Regulatory Bureau before a new hospital is built. It is also required for substantial alteration, expansion, renovation, more beds or added services. The order uses a Checklist for Review of Floor Plans to test planning and design against minimum standards (DOH AO 2016-0042). Ask the owner whether a later DOH issuance applies to the project.
| Facility | Regulator and rule |
|---|---|
| Drug plant | FDA, PIC/S Guide to GMP, AO 2012-0008 |
| New or renovated hospital | DOH Permit to Construct, AO 2016-0042 |
| Hospital floor plans | DOH Checklist for Review of Floor Plans |
Who builds cleanrooms here
Hospital owners are the clearest buyers, because a DOH-PTC applies to new hospitals and to renovation or added services. Drug manufacturers working to the PIC/S Guide are the second group. Sterile production rooms, operating rooms and similar controlled areas are where a cleanroom scope normally starts.
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 a DOH-PTC has been issued or is planned, and which PIC/S edition the owner's quality team uses. Say whether the rooms are for sterile products or for patient care, and whether the building is new or existing.
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 the FDA approve cleanroom contractors?
No. The FDA inspects the owner's drug establishment. The owner chooses and manages the contractor.
Which GMP guide do Philippine drug plants follow?
The PIC/S Guide to GMP, adopted by DOH Administrative Order 2012-0008. FDA Advisory 2023-0258 imposed PE 009-14, and RAPS reported an extension of conformity to 15 January 2025. Confirm the current edition with the FDA.
Is a Permit to Construct needed to renovate a hospital?
Yes where the work is a substantial alteration, expansion or renovation, or adds beds or services (DOH AO 2016-0042).
Is the Philippines a PIC/S member?
It is not on the PIC/S list of participating authorities checked on 31 October 2026.
Related guides
- The Cleanroom Project Lifecycle
- Writing a cleanroom URS: contents and testable wording
- How to Import a Cleanroom from China
- How to audit a cleanroom panel factory, on site or by video
- Turnkey cleanroom contractor
- Room list builder
Sources
- PIC/S, list of participating authorities (checked 31 October 2026)
- FDA Philippines, Advisory No. 2023-0258, implementation of the PIC/S Guide to GMP under DOH AO 2012-0008 (checked 31 October 2026)
- RAPS, Asia-Pacific Roundup: Philippine FDA extends transition to PIC/S GMP Guide (20 May 2024; checked 31 October 2026)
- Supreme Court E-Library, DOH Administrative Order No. 2016-0042, guidelines for the DOH Permit to Construct (filed 5 January 2017)
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