The "Data Integrity for Production and Laboratory Equipment" forum within the GAMP (Good Automated Manufacturing Practices) Committee of ISPE Turkey Affiliate was held on April 11, 2019 at Abdi Ibrahim Pharmaceuticals Esenyurt (Hadımkoy) with the contribution of over one hundred participants.

At the forum which attracted intensive attention, after the opening speech of the Chair of ISPE Turkey GAMP Committee Banu Refik, Chair of ISPE Turkey Affiliate MSc. Pharm. Buket Hekiman Bayraktar and Abdi İbrahim Pharmaceuticals Quality Operations Director Dr. Lütfü Şen, Gizem Taşgın (Abdi İbrahim Pharmaceuticals Quality Assurance Manager) shared information on Abdi İbrahim Pharmaceuticals’ data integrity applications in manufacturing and laboratory equipment and Jens Seest (Novartis Technical Operations Information Management Leader) elaborated on the topic of data integrity for production equipment.



In the second session of the forum following the coffee break, Gökhan Çetinkaya (Pfizer Production and Engineering Support Department Leader) shared information regarding data integrity studies on Pfizer production equipment. Afterwards, Hüseyin Çetinkaya (Novartis Senior Quality and Maintenance Coordinator), Sinem Sel (Novartis Quality Compliance Specialist) and Aysun Vanlı (Novartis Quality Operations Coordinator) shared the applications of Novartis with regards to data integrity studies for laboratory equipment.

In the third and last session held after lunch, the content of ISPE’s “Records and Data Integrity" guide was shared with the guests in detail by Işıl Şanlı Kirkit (ISPE Turkey GAMP Committee Vice Chair).



We would like to thank all participants for their interest in our forum where they also had the opportunity to ask questions to the speakers about industry practices with regards to Data Integrity for Production and Laboratory Equipment. We would also like to thank Abdi İbrahim Pharmaceuticals for their hospitality and contributions.