GMP Audits launched in 2011
Ofidit is the independent quality assurance company of Lab Ofichem in Liangzhu, China. It audits the Good Manufacturing Practices of pharmaceutical manufacturers in Asia, but its activities include more than just checking compliance.
Often 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. This means that even customers who buy small quantities of APIs can request a dust audit to help them choose their supplier.
Quality and Compliance
GMP evaluation of manufacturing sites of pharmaceutical ingredients, medicinal products and medical devices.
Through our audits, the manufacturer often improves the quality and compliance of the product!