ESENYURT
PRODUCTION COMPLEX

Quality Control Compliance is responsible for the preparation and revision of all the documents used in the Quality Control Laboratory through the "Qmex Quality Management" system, and the control of analysis results, and the management of semi-finished products, raw materials and packaging material approvals through SAP.

In the Microbiological Control Laboratory, microbial limit tests and pathogen detection tests, endotoxin and sterility tests of pure water, water for injection, pure steam, all primary packaging materials, raw materials and auxiliary materials used in production processes are performed and reported by using methods aligned with European and US pharmacopoeias. Similarly, areas, surfaces, equipment and personnel are controlled, and related processes are reported in accordance with European and US pharmacopoeias.

Ensures that the chemical control methods of semi-finished products, finished products, active and auxiliary substances are validated and documented in accordance with approved protocols and instructions aligned with cGLP and cGMP regulations as well as the regulations of the Republic of Türkiye Ministry of Health. In addition, it carries out quality control operations (such as analytical method transfer, process validation analysis, stability analysis) during the transfer of technology transfer products of our customers to whom we provide production services or proprietary products of Abdi İbrahim and our licensors to our company. It acts as a bridge connecting the quality control departments, provides the necessary analytical support – from the initial project phase to its submission to the authorities – and is responsible for preparing the relevant documents.

Regularly and accurately carries out the necessary reporting and analysis processes of the raw materials to be used in production in line with approved methods and specifications to check their compliance with the required level of quality and specifications. These activities are performed in accordance with GMP, ISO 27001 and ISO 13485 standards.

Performs the reporting and analysis processes of semi-finished products, finished products, active and auxiliary substances delivered to the laboratory in accordance with approved methods and specifications and in alignment with the regulations of the Republic of Türkiye Ministry of Health, in a timely and accurate manner. These activities are performed in accordance with GMP, ISO 27001 and ISO 13485 standards.

Carries out the long-term, bulk, transport, in use, photostability (light) and tracking stability analyses of all products produced by Abdi İbrahim, in compliance with the cGLP and cGMP regulations and in alignment with the regulations of the Republic of Türkiye Ministry of Health; and performs and reports process validation, R&D transfer, customer complaints and production trial analyses. 

Performs the sampling and physical control processes of semi-finished products, finished products, active and auxiliary substances in accordance with approved protocols and instructions aligned with cGLP and cGMP regulations as well as the regulations of the Republic of Türkiye Ministry of Health.  It performs product and packaging material label, document, print, machine and area cleaning checks and keeps a record of said checks before production (including pilot production) launch. If the results are sufficient to start production, it grants the approval to do so. During the production process, it performs the in-process controls of the products and records them according to procedure. It reports all the cases that are detected to be non-compliant with respect to any of the Culp written-approved procedures-instructions-controls and test specifications at any stage of the production process and ensures that appropriate actions are taken.

Performs the long-term, bulk, transport, in use, photostability (light) and tracking stability analyses of all products produced by Abdi İbrahim, in compliance with the cGMP regulations and in alignment with the regulations of the Republic of Türkiye Ministry of Health. These activities are performed based on the ICH, EMA, WHO, FDA guidelines that are recognized by international authorities.