The Good Manufacturing Practices (GMP) Guide for Human Medicinal Products Manufacturing Facilities has been updated by harmonizing it with the latest version of the GMP Guide numbered PE 009-17 published by PIC/S. In this context, updates have been made in the Annex-1 (Manufacture of Sterile Medicinal Products), Annex-13 (Manufacture of Investigational Medical Products) and Annex-16 (Certification and Batch Release by the Responsible Manager) sections of the Guide. 

In line with the approval of the Presidency of the Institution dated 26.03.2024 and numbered E-24931227-000-17993, the Good Manufacturing Practices (GMP) Guide for Human Medicinal Products Manufacturing Plants Version: 2024/04 entered into force on the date it was published. In addition, Annex-1 (Manufacture of Sterile Medicinal Products), Annex-13 (Manufacture of Investigational Medical Products) and Annex-16 (Certification and Batch Release by the Responsible Manager) sections of the updated Guide will be valid as of January 1, 2025 within the transition period. will be put into effect. During this period, Annex-1 (Manufacture of Sterile Medicinal Products), Annex-13 (Manufacture of Investigational Medical Products) and Annex-16 (Certification and Batch Release by the Responsible Manager) sections of the Guide, dated 22 April 2022 and numbered 2022/03, were updated. It will continue to be valid until January 2025.

Corrective and Preventive Actions regarding the deficiencies identified in the Annex-1 (Manufacture of Sterile Medicinal Products), Annex-13 (Manufacture of Investigational Medical Products) and Annex-16 (Certification and Batch Release by the Responsible Manager) sections during the inspections carried out on or after January 1, 2025 It must be completed within one year at the latest after the audit.

The current Guide is attached and information about the updated sections can be found in the attached file called "Guide History".

 Importantly announced to all concerned