In 2015 CFDA run a pilot program to start the oversea inspection for 2 manufacturers Johnson & Johnson and Roche Diagnostics, and now the program has been officially implemented for one year.
In 2017, totally 24 manufacturers were inspected in the UK , US ,German ..,etc. 10 countries, the products has been ranged from Plastic molding to IVDs and Implants , cardiovascular . Compare to 2016, there are 26% increase in the inspected manufacturers.
So far, 5 manufacturers have been appointed with government F2F meeting, talk with the finding during the inspection. 2 manufacturers have been issued market import alert and faced the commercial punishment.
The finding during past two years inspection are mainly happened in the field of
1) clean room
2) 3rd party test house
3) sterility test
4) production site address is different from the registration file.
....
In 2017, 24 manufacturers inspection, there 112 finding were issued and 16 recommendations were made.
In 2018, CFDA schedule to deliver 40 inspections, now is the time have manufactures attention to Chinese GMP regulatory compliance.
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ZeLi Yu, RAC Global
Independent Regulatory Consultant
Mobile +86-13901867634
Email:
13901867634@163.comYUZELI MEDTECCONSULTING, MONTREAL, QC, CANADA
Shanghai Compliance Med Dev Scientific Technology Co. Ltd. Shanghai, China
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