Recent Development
The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently announced that the Good Manufacturing Practice (GMP) Guide for Manufacturing Plants of Medicinal Products for Human Use (the “Guide”) was updated.
What Does the Announcement Say?
The TİTCK has announced that to harmonize the practical implementation among the members of the Pharmaceutical Inspection Co-operation Scheme (the “PIC/S”), the updates of Part 1 – Chapters 1, 2, 6 and 7 in the PIC/S GMP Guide: PE 009-13 published by the PIC/S was incorporated into the Guide.
The Presidency of the TİTCK approved the Guide on September 7, 2017 and it will enter into force on October 1, 2017. The Guide is available in both Turkish and English. The English version is accessible at here.
Conclusion
The TİTCK continues to demonstrate its commitment to providing comprehensive guidelines for companies engaged in medicinal products for human use. Companies should take note of the new updates and take the necessary steps to ensure compliance.
