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Ofidit is the independent quality assurance company of Lab Ofichem in Hangzhou, China. It audits the Good Manufacturing Practices of pharmaceutical manufacturers in Asia, but its activities include more than just checking compliance.

Contact

Gudun Road 1899 Unit A1-407
311113 Liangzhu
China

T+31 (0)599 583 433
Einfo@ofichem.com

Guaranteeing quality

Ofidit is the independent quality assurance company of Lab Ofichem in Hangzhou, China. It audits the Good Manufacturing Practices of pharmaceutical manufacturers in Asia, but its activities include more than just checking compliance.

THROUGH OUR AUDITS, THE MANUFACTURER OFTEN IMPROVES THE QUALITY AND COMPLIANCE OF THE PRODUCT!

Independent audit

“Often”, explains Philippe André, GMP auditor and qualified pharmacist for Ofidit, “the same substance is made in different locations under vastly different conditions. Our audits not only verify the level of compliance in a factory, but they also look at the correlation between the price of an API and the investments made to improve protection, and therefore quality, during production. The audits also look at the integrity of the analytical data used for product release.

“We ensure that we emphasise the independence of our audit work and this often leads to the manufacturer working with the customer to ensure the quality and compliance of the products being audited. We consider it a privilege that our work makes this dialogue possible.”

Many of Ofidit's audits are commissioned by multiple clients. Each client's privacy is protected, but together they benefit from a thorough independent audit for which the costs can be shared. André claims, “It means that even customers who buy small quantities of APIs can request a dust audit to help them choose their supplier.”