Cleanroom contractor in Bolivia: rules for buyers

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

Which rules apply to your plant

Article 19 of the Medicines Law, Ley 1737 of 17 December 1996, says an industrial pharmaceutical laboratory must be authorised and registered in advance, have suitable facilities, machinery and a quality control laboratory, and follow good manufacturing practice (BPM) and good laboratory practice, with periodic inspections and technical audits (Lexivox, Ley 1737).

Supreme Decree 25235 of 30 November 1998 implements the law. Article 8 asks for the building plans of the premises, approved by the municipal mayor's office (Alcaldía) and conforming to BPM. Article 37 adds an on-site inspection of installations, equipment and plant set-up, and an environmental impact declaration. Article 38 makes a BPM inspection a condition of the annual re-registration (Lexivox, DS 25235).

AGEMED was created by Supreme Decree 2905 of 21 September 2016 and issues licences, company openings and BPM certifications by administrative resolution (article 7). Its Administrative Resolution 010 of 3 May 2023 sets the validity of BPM and storage-practice certificates at two calendar years (AGEMED).

Who builds cleanrooms here

Industrial pharmaceutical laboratories are the regulated buyers, because article 19 requires proper facilities and a quality control laboratory before authorisation. Article 39 of Decree 25235 lets a business that fractionates or packs bulk medicines operate only after meeting the requirements set for industrial laboratories. This reading comes from the legal texts, not from market statistics.

What a foreign supplier must arrange

Decree 25235 puts responsibility for medicine quality on the owners of national or foreign industrial laboratories (article 32) and asks for BPM compliance for national and imported products alike (article 31). Article 29 declares the WHO GMP norms and inspection guide adequate for Bolivia and applies them in preference to ISO 9000 standards (AGEMED, 2023). This page found no official Bolivian source on product approvals or contractor registration, so ask the owner which Alcaldía reviews the plans and who files them.

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. Use a form the owner's architect can submit to the Alcaldía. State whether the plant is new or existing, whether the rooms are sterile, and whether the owner is applying for authorisation or renewing. Name the technical director and the quality control head who will receive the inspection.

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

• Building a cleanroom inside an existing building
• Writing a cleanroom URS: contents and testable wording
• How to choose a cleanroom contractor: questions and evidence
• How long does it take to build a cleanroom?
• Turnkey cleanroom contractor
• Room list builder

Sources

• Lexivox, Bolivia: Ley del Medicamento (Ley 1737), 17 December 1996 (checked 1 November 2026)
• Lexivox, Bolivia: Decreto Supremo 25235, 30 November 1998 (checked 1 November 2026)
• Lexivox, Bolivia: Decreto Supremo 2905, 21 September 2016, creating AGEMED (checked 1 November 2026)
• AGEMED, Resolución Administrativa 010, 3 May 2023
• PIC/S, list of participating authorities (checked 1 November 2026)