AUDIT - GOOD MANUFACTURING PRACTICES (GMP)
The evaluations made by AIFD on both the improvement of processes and the published legislation were shared with the Vice Presidency of Pharmaceutical Inspection Services of the TITCK through official letters. The problems and solution proposals were also discussed verbally during the meetings. Information on the relevant correspondence and face-to-face meetings are provided below.
- AIFD official opinion letter dated 19/04/2022 on the Draft Regulation on Pharmaceutical Traders and Products Stored in Pharmaceutical Traders
- Meeting with Dr. Sevil Azak Sungur, Vice President of Audit Services at TITCK, on 22/06/2022.
- AIFD official opinion letter dated 18/07/2022 on Guidelines for Applications for GMP Audits of Overseas Production Facilities
- Official letter dated 02/08/2022 about the Frequently Asked Questions document collected from AIFD member companies.
- Meeting on 08/11/2022, with Dr. Pharm. Sevil Azak Sungur, Deputy Head of TITCK Audit Services, and Ms. Filiz OZUL(ChE), Head of TITCK Inspection Services
- AIFD official opinion letter dated 02/12/2022 on the Revised Guidance on Applications for GMP Audits of Overseas Production Facilities
The legislation published by the TITCK Drug Control Department during 2022 is presented under the heading 2022 Legislative Developments.
As an important development, based on the announcement made by the relevant Department on December 30, 2022, it was shared that on-site GMP audits will be planned in production facilities in other countries according to the assessments made on the basis of risk, taking into account that the restrictions imposed due to the pandemic have been lifted in some countries and the normalization process has started. The said announcement includes details on the extension of GMP Certificates.
