With the announcement of Turkish Medicines and Medical Devices Agency dated August 9, 2022, “Trust Guide for Evaluation of Good Manufacturing Practices” was published and entered into force.
The guide regulates the procedures and principals to be applied for the evaluation of information and documents prepared as a result of on-site inspections carried out by the supervisory/regulatory authority of the country where the facility is located, or by regional or international organizations, in compliance with Good Manufacturing Practices inspections of the production sites of medicinal products for human use produced abroad and imported into our country, within the scope of trust.
The guide generally provides the principles to be applied in accepting information and documents within the scope of trust, the concept of trust and the comparability of authorities, within the framework of the World Health Organization (WHO) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines.
You can reach the guide via the below link:
https://lnkd.in/dKznMh87