Ofidit, Lab Ofichem’s independent quality assurance company in Hangzhou, China, audits the Good Manufacturing Practices of pharmaceutical manufacturers in Asia, but its activities cover more than just checking regulations are being met.
“Often,” explains Philippe André, GMP Auditor and Licensed Pharmacist for Ofidit, “the same substance is made in very different conditions at different sites. Our audits don’t just verify the level of compliance in a factory, they look at the correlation between the price of an API and the investments made to enhance its protection, and therefore quality, during production. What’s more, the audits look at the integrity of the analytical data used for product release. We take care to emphasize the independence of our auditing work and more often than not this results in the manufacturer collaborating with the client to work on the quality assurance and compliance of the audited products. Consider it a privilege that our work facilitates this dialogue.”
Many of Ofidit’s audits are carried out on behalf of 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: “It means that even clients purchasing small amounts of API’s can request a substance audit to help them in their choice of supplier.”
OUR AUDITS OFTEN RESULT IN THE MANUFACTURER IMPROVING THE QUALITY AND COMPLIANCE OF THE PRODUCT