The regulation is as follows:

ANNOUNCEMENT ABOUT THE INSPECTION OF BIOAVAILABILITY/BIOEQUIVALENCE CENTERS


The Bioavailability/Bioequivalence Centers (BA/BE) to which related companies apply for  drug license in Turkey, should be inspected by the Directorate General of Pharmaceuticals and Pharmacies in terms of “Good Clinical Practice (GCP)” for clinical centre and bioanalytical laboratory.

Required data and documents for the application dossier related to inspection of Bioavailability/Bioequivalence Centers are mentioned as in the following.


Application Dossier:

General information,
Layout of the center (plan),
Organization chart,
Study flowchart,
CVs of key staff (quality control director, for instance),
List of Standard Operating Procedures (SOP),
Lists and certificates of previous inspections and audits, if performed,
With a copy, the bank receipt of the application fee announced in the web page of the Ministry,
Authorization certificate given by the center to agent located in Turkey if the inspection of the foreign-based center is demanded.
* Application dossiers of the Bioavailability/Bioequivalence Center including both clinical centre and bioanalytical laboratory should be prepared separately.