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The 1st PIC/S Expert Circle Meeting on Control of Cross Contamination in Shared Facilities- hosted by Taiwan FDA the first time

【Update Date:2019-06-18unit:品質監督管理組

  The 1st PIC/S Expert Circle Meeting on Control of Cross Contamination in Shared Facilities (CCCISF) will be held from June 19th through 21st, 2019. This is the fifth time that Taiwan FDA has hosted PIC/S events on various topics for the “Pharmaceutical Inspection Convention and Co-operation Scheme” (PIC/S). Inspectors and health authority officials from 22 countries, including Europe, North America, South America, and Asia, will gather in Taipei for training and experience exchange on the control of cross contamination subject.

  Invited speakers of this meeting are from health authorities of pharmaceutical leading countries such as UK MHRA, US FDA, Germany BfArM and Italy AIFA. It should be noted that Mr. Graeme McKilligan from UK MHRA, the chairman of PIC/S CCCISF expert circle, who leads the revision of PIC/S GMP Guide and implementation of EU Health Based Exposure Limit (HBEL) Guideline. He will share the latest requirement on cross contamination prevention when the drugs are produced in shared facilities. Other topics include how to perform and effective cleaning base on risk assessment and toxicology assessment, and the result should be able to demonstrate that there is no risk of contamination. It is expected that inspectors can understand the sources of cross contamination and conduct inspection effectively and scientifically. More importantly, achieve harmonized international GMP standard.

  The PIC/S is the assembly of GMP inspectorates leading the global harmonization of GMP standard for medicinal products, and establishes this CCCISF expert circle in 2017. The first meeting of this expert circle is hosted in Taipei by TFDA, represent that TFDA is highly recognized by the global community. Moreover, TFDA expects the meeting outcome could be contributed to the revision of aide memoire to assure global medicinal product safety.