YaoPharma’s API site (Carelife) re-passed the site inspection from ANVISA

14 / 04 / 2014

Carelife re-passed the site inspection conducted during March 31 to April 2 by Brazil ANVISA for Clindamycin HCl.

 

According to the audit agenda, in addition to thorough inspection to the manufacturing site, QC, documentation system of QA, the auditors paid special attention to product export, manufacturing process, purified water system, validation of HVAC system, as well as equipment operation and maintenance. They also gave us suggestions on how to adapt to cGMP requirements. During the closing meeting, the auditors praised our good manufacturing practices as well as the documentation system, and also pointed out the deficiencies observed during the inspection. The leaders in our company promised that we will pay close attention to the mentioned deficiencies, make corrective actions and try to avoid similar problems in future, and improve our GMP management continuously.