Vergleich des EG-GMP- Leitfadens Teil I mit der SFDA-GMP-Guideline für chinesische Firmen
Dr. Heinrich Prinz1 und Dr. Christian Schulz2
PDM-Consulting1, Groß-Zimmern, und Dolder AG2, Basel
Contract manufacturing of pharmaceutical products such as Active Pharmaceutical Ingredients and Finished Pharmaceuticals – or manufacturing steps thereof – will be performed very often in the Federal Republic of China, initiaded by European or German 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.
The following publication compares the requirements of the SFDA GMP and the EC GMP Guideline Part I for Finished Pharmaceuticals.
The requirements of the Chines GMP Guideline for the manufacturing and quality control of the finished pharmaceuticals will lead only basically to an acceptable quality standard. To adhere finally to the EC GMP Guideline the Chinese companies must append the missing parts.