Audit Period : April 23~26th, 2019
Place : TRACOE medical Gmbh, in Nieder -Olm, Germany
For the audit for KGMP renewal, Mr. Lee Yong-ho, the auditor of KTC, Cho Byung-ok and Kang Eun-kyoung of Hongeun Medical co. Ltd visited TRACOE Medical Gmbh, a manufacturer and supplier of tracheotomy tubes
The KGMP audit was conducted for five days from April 23 to 26 from the inspection of TRACOE's manufacturing facilities at the first date.
The quality management of the TRACOE was evaluated in depth by inspecting the relevant documents and by interviewing the managers of each department.
And the GMP audit for renewal was finished successfully and it was approved to extend GMP for next three years
That means TRACOE observes the standard of Korean GMP as a manufacturer of Medical devices well and the tracheotomy tubes of TRACOE are safe to the patients.