Cleanroom contractor in Panama: rules for buyers

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

Which rules apply to your plant

Executive Decree 27 of 10 May 2024, published in Gaceta Oficial Digital 30028-C, regulates Law 419 of 1 February 2024. Article 379 requires any pharmaceutical establishment that manufactures, packs, imports or sells regulated products to hold an operating licence. Article 3 lets the Directorate certify GMP after an audit, and article 517 says medicine makers follow the Central American GMP regulation and its verification guide (Decreto Ejecutivo 27 of 2024).

To request a GMP audit, article 645 asks for an application form, the fee receipt, a self-assessment and a site master file. Under article 646, a first certificate needs 95 percent of critical criteria and 90 percent of major and minor criteria. From the first renewal, the laboratory needs 100 percent of critical and 95 percent of major and minor criteria.

The regulation, RTCA 11.03.42:07, entered Panamanian law by Executive Decree 267 of 21 October 2014 (Gaceta Oficial 27672-A) and was later amended by COMIECO resolution 444-2021 (Ministry of Commerce and Industries list, 4 October 2023).

The decree also places Panama in climatic zone IVb, hot and humid, with reference values of 30 degrees C and 75 percent relative humidity. Tell the owner's HVAC designer.

Who builds cleanrooms here

Medicine manufacturers are the regulated buyers, because article 379 requires an operating licence for manufacture. Articles 519 onward set separate GMP rules for makers of cosmetics, antiseptics, disinfectants and household pesticides. For those makers, articles 541 and 543 require surfaces that do not shed particles and production areas with air control for temperature, humidity and filtration. This page does not cover hospital rules.

What a foreign supplier must arrange

MINSA audits the owner's laboratory, and the site master file and self-assessment come from the owner. A foreign supplier should therefore expect requests for drawings, material specifications and qualification records that the owner can file. This page found no official Panamanian source on construction-product approvals or contractor registration, so ask the owner's engineer which approvals apply.

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 medicines or cosmetics, whether the rooms are sterile, and whether the owner holds an operating licence or is applying for one. Name the pharmacist in charge (regente).

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. CE-marked and FM-approved panels can be supplied for projects that require them, and other certification 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 long does it take to build a cleanroom?
• How to choose a cleanroom contractor: questions and evidence
• Turnkey cleanroom contractor
• Room list builder

Sources

• Ministerio de Salud, Decreto Ejecutivo 27 of 10 May 2024, Gaceta Oficial Digital 30028-C (checked 1 November 2026)
• Ministerio de Comercio e Industrias, list of Central American technical regulations adopted by Panama (updated 4 October 2023)
• PIC/S, list of participating authorities (checked 1 November 2026)