GMP Inspections of Foreign Manufacturing Sites

Manufacturing sites of human medicinal products and advanced therapy medicinal products manufactured abroad and imported into Türkiye are in scope. The inspection covers manufacturing steps such as bulk production, primary and secondary packaging, quality control and batch release. Active substance sites for conventional products are not included in the inspection scope, although the Agency reserves the right to inspect them. For biological, biotechnological, biosimilar and advanced therapy products, an application is also required for the active substance site if the active substance is made elsewhere.

The application is made by the importer established in Türkiye. Application forms are completed separately for each product, manufacturing site and pharmaceutical form, and one application dossier may not cover more than one site. Technical documents must be prepared by the manufacturing site and signed by its head of quality assurance, head of production or responsible person. Documents in languages other than English are submitted with Turkish or English translations.

On-site inspections are carried out at sites not previously inspected by TİTCK and at sites where post-inspection changes require one. A desk-based (dossier) assessment relies on a product already inspected on site and found compliant by TİTCK: for example, other strengths of the same product, other products made on the same line and equipment, or co-marketed products. A risk-based assessment is used to extend the validity of an existing GMP certificate.

For sites not previously inspected, on-site inspections are scheduled according to the priority order set under the Priority Evaluation Board (ÖDEK) guideline. The marketing authorisation or inspection application must be made within 6 months of notification of the priority decision. For a product granted priority for inspection, a marketing authorisation application must already have been filed and have passed CTD pre-review before the inspection application.

A certificate issued after an on-site inspection is valid for 3 years from the inspection date. It is extended by 3 years at a time through a risk-based assessment application, which can be filed at the earliest 6 months before expiry. A single on-site inspection can serve as the basis for up to 12 years for sites in PIC/S member countries (3 risk-based assessments) and up to 9 years elsewhere (2 risk-based assessments).

If one or more critical deficiencies, or a number of major deficiencies amounting to a critical one, are found at an on-site inspection, the certificate request is rejected. No new on-site inspection application is accepted for 6 months from notification of the outcome. The new application must include evidence that the deficiencies have been corrected and a current priority decision, and inspection fees are paid again. If critical deficiencies are found at an on-site inspection ordered after a risk-based assessment, the certificates of the products concerned are cancelled and their import is stopped.

For conventional products, a GMP certificate issued by a competent health authority for the active substance site is submitted in the marketing authorisation dossier. No apostille is required for current documents published on the official EUDRA GMP and FDA websites. GMP certificates without an expiry date are accepted as valid for 3 years from the inspection date.

Yes. To add a product to a scheduled on-site inspection, the application must be made at least 15 working days before the inspection date. Requests to remove products must be notified within the same period under the “Yurt Dışı İyi Üretim Uygulamaları (GMP) Bildirimler” (GMP Notifications) document type. Because these changes affect the scope and the number of inspection days, the deadlines matter.