New Guideline on GDP Inspections Published by Turkish Authority

The Turkish Medicines and Medical Devices Agency (TITCK) has recently released an updated version of its guidelines pertaining to inspections concerning the storage and distribution of medicinal products intended for human use.

Initially introduced in February 2022 under the identifier IDD-KLVZ-01, the guideline underwent its first revision in November 2022. The most recent revision, which has now been published, came into effect on 20th June 2023.

The primary objective of this document is to offer comprehensive guidance on inspections related to the storage and distribution of medicinal products for human use. Its aim is to ensure that audits are conducted in compliance with the existing national legislation and to standardize the inspection procedures.

The original version of the guideline in Turkish can be downloaded as a PDF document from the authority's official website, whereas the translated version in English you can find here https://www.dhirubhai.net/feed/update/urn:li:ugcPost:7087274464861700096/

Key Content of the Updated Document

The newly revised guideline comprises the following sections:

1. Introduction (including the objective, scope, definitions, and abbreviations)

2. Inspections conducted by authorities (including information on the application process, pre-certification audits, and certification procedures)

3. Administrative sanctions

4. Audits and evaluations carried out by other public institutions and organizations

5. Enforcement

6. Execution

7. Appendices

8. Revision history

According to the revision history, several amendments have been made in the basis, definitions, and subsections 2.1 and 2.3 when compared to the previous version. Additionally, subsections 2.2.3 and 2.7 have been newly added to the document.