Cleanroom contractor in Turkey: rules for buyers

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

Which rules apply to your plant

The Regulation on Manufacturing Sites of Human Medicinal Products (Beşeri Tıbbi Ürünler İmalathaneleri Yönetmeliği) was published in Official Gazette no. 30217 on 21 October 2017. Article 7 allows manufacture only at sites with a production site permit from the Agency, under good manufacturing practice principles and guidelines. The same article applies the rule to sites that make medicines only for export (TİTCK, regulation text).

The regulation also provides for a GMP Certificate for sites that hold a permit. It covers medicinal products, their active substances and clinical trial products (Articles 1 and 2). An amending regulation appeared in Official Gazette no. 33407 on 21 October 2026. It updates the legal basis in Article 3, adds definitions in Article 4 and extends the product lists in Article 7(3) (Alomaliye, 21 October 2026). Ask the owner's regulatory team which text applies to the project.

PIC/S lists TİTCK among its participating authorities, with accession in January 2018 (PIC/S, checked 31 October 2026).

Who builds cleanrooms here

The Pharmaceutical Manufacturers Association of Turkey (IEIS) reports 111 pharmaceutical manufacturing facilities operating in line with international standards as of December 2025. They are 102 pharmaceutical plants and 9 radiopharmaceutical sites, and there are 15 active substance plants as well. The count was 66 in 2015 (IEIS, Turkish Pharmaceutical Industry 2025, from TİTCK data).

IEIS also reports 13 modern biotechnology manufacturing facilities and four plants making foods for special medical purposes. It notes that biotechnological medicines are among the strategic sectors of the HIT-30 Project (IEIS, Turkish Pharmaceutical Industry 2025).

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 is new or existing and whether the rooms are sterile or non-sterile. Say whether the owner plans a TİTCK permit or GMP Certificate application, and name the quality head who will review the design.

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 audit a cleanroom panel factory, on site or by video
• Building a cleanroom inside an existing building
• Writing a cleanroom URS: contents and testable wording
• How to choose a cleanroom contractor: questions and evidence
• Turnkey cleanroom contractor
• Room list builder

Sources

• PIC/S, list of participating authorities (checked 31 October 2026)
• TİTCK, Beşeri Tıbbi Ürünler İmalathaneleri Yönetmeliği, Official Gazette no. 30217, 21 October 2017
• Alomaliye, amending regulation, Official Gazette no. 33407 (21 October 2026)
• IEIS, Turkish Pharmaceutical Industry 2025 (data as of December 2025; checked 31 October 2026)