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The 1st PIC/S Expert Circle Meeting on Control of Cross Contamination in Shared Facilities (CCCISF) concludes successfully- Taiwan FDA takes an active role in PIC/S activities

【Update Date:2019-06-21unit:品質監督管理組

  The three-day 1st PIC/S Expert Circle Meeting on Control of Cross Contamination in Shared Facilities (CCCISF) has successfully concluded in Taipei today, June 21st 2019, with 82 distinguished PIC/S experts and inspectors in attendance from 20 countries including United Kingdom, Germany, Denmark, Spain, Canada, United States, Brazil, Ukraine, Korea, Malaysia and Japan. The participants from GMP inspectorates around the world shared their knowledge on preventive control strategies of cross-contamination in shared facilities. Topics on the PIC/S GMP Guide revision and inspection procedures and skills enhancement are covered.

  Cleaning and disinfection procedures validation on facilities and equipment as well as proper design of personnel and material flows are measures on cross contamination control in shared facilities. Chapters 3 and 5 of PIC/S GMP and guideline of health based exposure limits (HBEL) are both requirements to follow. This PIC/S expert circle meeting emphasizes the practical experience as the most important learning way and arranged workshops and case studies throughout the three days to allow the inspectors to brain storm the possible sources of cross contamination, to discuss the potential risks and difficulties during inspection, and share experience. The meeting also output suggestions for inspection tools including PIC/S guidelines and aide memoir.

  This event was successfully concluded and all participants give positive feedback on the input of Taiwan FDA and appreciate the support from PIC/S. This CCCISF Chairman Mr. Graeme McKilligan noted in the closing remarks his special thanks to Taiwan FDA colleagues for organizing and hosting this meeting. He recognized the participants from the world all enjoyed the three-day productive meeting. Besides new knowledge on inspection is able to take home, the participants were surrounded by the warm hearted people and learn the culture and hospitality of TFDA. Taiwan FDA once again accomplished its mission in international diplomacy.

  This event marked a continuation of the successful partnership between Taiwan FDA and PIC/S. Additionally, to ensure our regulation and management system moves in line with the international standard, Taiwan FDA will remain actively engaged in the global community to raise its international profile and boost our international competitiveness.