FDA Reacts to Recent Problem Cases and Establishes GMP Inspection Office in China

GMP News
16 April 2008

FDA Reacts to Recent Problem Cases and Establishes
GMP Inspection Office in China

For many years, there has been a rumour going around that the FDA wants to establish an office for inspectors in China. Up till now, this project has not been realised, among other reasons because an authority can only set up a branch office in a foreign country if that country gives its permission.

The recent cases of GMP deviations and drug counterfeiting have accelerated this process a great deal. On 14 March, the FDA informed the public that a GMP inspection team will be built up at the embassy in Beijing and the consulates in Shanghai and Guangzhou. For this team, the FDA also wants to recruit staff from China in order to be able to check the documentation and routines in more detail than before during inspections, e.g. by questioning the personnel on site.

The low number of inspections in China was one of the main points of criticism brought up during two US Congress Hearings. A report by GAO had revealed that the number of inspections conducted in China bore no relation to the fast-growing number of manufacturing sites. This is especially true of API (active pharmaceutical ingredients) manufacturers. Here, estimates suggest that more than 80% of the APIs for medicinal products registered with the FDA have to be imported - the greatest part of them from Asia, above all from China. Shifting the production to China was a measure taken by many pharmaceutical companies in order to optimise the manufacturing costs. Now it turns out that a great many Chinese plants do not even fulfil a minimum of GMP. Apart from that, the number of counterfeit medicinal products has increased at a pace hardly imagined possible. The FDA now reacts in a consistent way.

The number of inspection in China will multiply. It is to be expected that the problems that have recently become known (like e.g. heparin production) are no isolated cases. It is assumed that many firms will receive a warning letter, since they have never been inspected before. This is also due to the EDP systems used by the FDA. In the topical heparin case, the FDA had inspected the wrong factory because of a system error. After this had been found out, a GMP inspection was scheduled at short notice. The GMP deviations on the 483 form are alarming. In the meantime, the plant in question has been shut down.

Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

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