Pharmaceutical News
The 1st CCCISF meeting held in Taiwan by the TFDA
2019/06/23

The 1st PIC/S Expert Circle Meeting on Control of Cross Contamination in Shared Facilities (CCCISF) has successfully concluded in Taipei on the 21st.  Total 82 inspectors and experts from 20 countries, including the UK, Germany, Denmark, Spain, Canada, the US, Italy, Brazil, Ukraine, South Korea, Malaysia, Japan and Taiwan, attended this 3-day event.  The inspectors and experts discussed about the preventive measures for cross-contamination in shared facilities, the recent revision of the PIC/S GMP Guidelines, the ways to improve inspection, etc.

The equipment, facilities, manufacturing processes, cleaning procedures and personnel/material flows are crucial factors in the control of cross-contamination in shared facilities.  Inspectors carry out the inspections primarily based on the requirements set out in Chapter 3 and Chapter 5 of the PIC/S GMP Guidelines and the principles of “Health Based Exposure Limit (HBEL)”.  The meeting arranged a series of workshops and case studies for participants to share their practical experiences and to exchange comments.  Participants were updated with the possible sources of cross contamination, the potential risks and difficulties in inspection and the new inspection tools provided by the PIC/S, such as revised guidelines and inspection memorandum.

The efforts of the TFDA staff and the support from the PIC/S have made this event fruitful with positive feedback from all participants.  Mr Graeme McKilligan, the chairman of this meeting, thanked the TFDA for organizing and hosting this event.  The participants not only obtained new knowledge, but also experienced the culture of Taiwan.

After the meeting, the TFDA will continue to work with the PIC/S to ensure the regulation and quality management system in Taiwan move in line with the international standards so as to help the pharmaceutical industry to boost the competitiveness and enter the global markets. 

【2019-06-18 / TFDA News】