The China Food and Drug Administration published a 56-page 2015 Annual Inspection Report. This is the first report of its kind that I’m aware of and unusual in publications from the CFDA in that it is in English. The Agency is to be congratulated on this level of transparency and we encourage them to continue.
The report addresses GMP inspection and covers pharmaceuticals including APIs, herbal medicines, vaccines, and traditional Chinese medications. The report does not cover inspection of device manufacturers, sites that are associated with the conduct of investigational studies (GCP) or pre-clinical laboratory studies (GLP). The report includes seven sections as follows:
Section I: Inspection of Pharmaceutical GMP Certification
Section II: Pre-Approval Inspection
Section III: Follow up Inspection
Section IV: Unannounced Inspection of Pharmaceuticals
Section V: GAP Inspection of Chinese Crude Medicines
Section VI: Overseas Inspection of Imported Pharmaceuticals
Section VII: Observation of GMP Inspections by Foreign Regulatory Organizations
Sections I-VII are subdivided into two additional areas: 1) Overview of Inspection and 2) Findings. Section VII includes an additional category of ‘Analysis of Characteristics of GMP Inspections by Different Inspection Organizations’. The report includes many data graphs showing the types of sites inspected and the stages of manufacture such as API, dosage form, sterile products, and lyophilized products.
I found it interesting that the China FDA’s top areas for observations included QC/QA, document management and equipment. They also identify the area of data integrity as problematic including outright forgery of results, lack of raw data, and lack of complete laboratory data. Manufacture of sterile products is often found to be deficient. They further identify that in inspections outside of China the firms often did not comply with the China GMP requirements.
Personally, one of the most interesting sections is Section VII that describes CFDA experience in shadowing other global regulatory authorities on their inspections. A total of seventy-four inspections are included in this effort. Agencies with which they participated on inspections include the FDA, EDQM, WHO, selected EMA member states, and ANVISA. This section also looks at differences in the average number of observations and the areas of observations for each inspection agency. While there are some very real differences, the similarity of results is striking.
Bottom line, read through the report, or at the very least read Sections VI and VII. Again, congratulations to CFDA for publishing this report and we look forward to more of these in the future.