The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently published on its website the Guidelines on Contracted Analysis Laboratories for Medicinal Products for Human Use (the “Guidelines”). The Guidelines are effective from the publication date and they repeal the previous guidelines dated January 25, 2017.
The Guidelines have been adopted based on the Regulation on Factories of Medicinal Products for Human Use to establish the principles and procedures for contracts between manufacturers or importers with laboratories outside manufacturing sites for inspecting the manufacturing process. In this context, the Guidelines impose certain obligations on laboratories that conduct such inspections; including specifying certain levels of quality and compliance with the Good Manufacturing Practices.
The new Guidelines introduce slight revisions to the previous guidelines. In this regard, the new Guidelines provide a more flexible regime for laboratories, which are no longer required to obtain ISO 17025 certification, but instead must retain an appropriate quality management and documentation system. I
n addition, while under the previous guidelines approval for such procedures was granted for the relevant analysis and the laboratory conducting such analysis, the new Guidelines introduce an approval system for the manufacturer or importer contracting with the laboratory for such analysis. Therefore, approved manufacturers or importers may not contract with laboratories that do not comply with the conditions set forth under the Guidelines. Previously, the approval granted for the non-compliant laboratory would have been cancelled.
The TİTCK continues its commitment to providing guidance for companies engaged in pharmaceutical products and medicinal products for human use. Companies, therefore, should closely follow the announcements made by the TİTCK and take the necessary steps to ensure compliance with any recent development that may affect their activities.