GMP: Chinese vs. European regulations

Contract manufacturing of pharmaceutical products such as Active  Pharmaceutical  Ingredients and Finished Pharmaceuticals - or manufacturing steps thereof - will be performed very often in China, initiated by European companies. It is a legal obligation to perform an audit at the site of contract.

The work executed at the Chinese company has to be performed according to the European GMP Guideline. To understand and to assess the differences between the European GMP requirements and those from the SFDA GMP,  it  is  beneficial  to  have knowledge about the content, the implementation and the understanding of both, the guidelines of Europe and those of China.

Dolder, in cooperation with Dr. Heinrich Prinz, published a comprehensive article in PharmInd Magazine, comparing the requirements of European and Chinese GMP Guideline Part 1. Download the PDF-File here (193KB).

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