Turkish Authority publishes new Guideline on GDP Inspections

The Turkish Medicines and Medical Devices Agency (TITCK) has published a new revision of its guidelines related to inspections regarding the storage and distribution of medicinal products for human use.

The first version of the guideline with the identifier IDD-KLVZ-01 came into effect in February 2022. The document was first revised in November 2022. The effective date for the second revision, which has now been published, was 20 June 2023.

The purpose of the document is to provide guidance on inspections related to the storage and distribution of medicinal products for human use. It is also about to ensure that audits are carried out in accordance with the national legislation in force and to standardise the way inspections are performed.

The original document in Turkish is available for download as a PDF document on the website of the authority. 

Content of the new Document

The newly revised document is divided into the following sections:

• 1. Introduction (including objective, scope, definitions and abbreviations)
• 2. Inspections carried out by authorities (including information an the application process, pre-certification audits, certification procedures)
• 3. Administrative sanctions
• 4. Audits and evaluations conducted by other public institutions and organisations
• 5. Enforcement
• 6. Execution
• 7. Appendices
• 8. Revision history

According to the revision history, compared to the previous version, the basis, definitions, subsections 2.1 and 2.3 have been amended, and subsections 2.2.3 and 2.7 have been added.