China 3rd Party Audits – Last Call

Gempex and gemro respectively will be your partner when sourcing critical material from China. This includes the selection and evaluation of potential suppliers as well as auditing and follow-up support. From beginning of August until end of October 2012 the GMP experts are again in China staying with their joint venture colleagues from gemro services, doing 3^rd party audits as well as follow-up visits.

This is your opportunity not only for saving money when ordering 3^rd party audits in Asia but also to have the full expertise of western senior consultants and Chinese GMP experts in place.

Sourcing APIs, intermediates, excipients or any other raw materials in a good and reliable quality from China is a challenging task by itself. Sourcing those kinds of products as EU/ US GMP compliant products becomes nearly unrealizable. Still the topic quality as well as the fulfillment of western GMP requirements is a big issue in China as the last bad case - capsules contaminated with chromium - has shown. Is it just criminal activity or is it only missing knowledge and bad understanding of what is expected for quality in the western world? For sure it is a mix of both whereas the missing knowledge and understanding seems to be the major problem. This is not surprising as China started very late its development to become a highly industrialized country and people still have to catch up with this very fast development.

Sourcing the aforementioned products in the desired quality therefore requires not only the GMP knowledge when doing audits, this also requires a deep understanding of the country, the people living in the country, their culture and the basic problems coming up with such highly regulated manufacturing processes. Gemro - a joint venture between gempex and HeRo - is addressing exactly those problems by combining the western GMP know-how with the Chinese cultural understanding. HeRo is operating more than 25 years in China Mainland with Chinese experts who are aware of the basic problems. 3^rd party audits are therefore executed by western GMP experts together with the Chinese colleagues and so far provides the best condition to fulfill this task successfully.

Contact us as a professional partner experienced in GMP and Chinese culture.