Chinese FDA is performing more international Inspections
Recommendation
29/30 April 2025
Hamburg, Germany
Batch Manufacturing Documents: from Preparation to Operational Excellence
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The China Food and Drug Administration (CFDA) has published its "Annual Report of Drug Inspection 2016". This report mainly lists summarised results of inspections performed by CFDA in China. But in Part V of the report, an overview is given on international inspection activities:
The total number of CFDA overseas inspections performed last year was 49 inspections in 19 countries. A number which has been constantly growing over the last years:
Most of these inspections (33) were performed in Europe. Six were performed in North America. Countries like Vietnam and India are called "countries with high regional quality risks" in the report. However, only one Indian company was inspected.
Overall, 40 different products ("chemicals") were covered in the inspections, including "injections, solid preparations, implants and nasal sprays".
Most observations were made in Quality Control and Quality Assurance (22 with 6 major deficiencies), Material System and Change Management. Serious deficiencies were mainly noted as "problems in the consistency of production process and data integrity". Deficiencies in local inspections were mainly observed in the areas of Quality Control and Quality Assurance and Documentation Management.
Source: CFDA Annual Report of Drug Inspection 2016
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