Publish Date:08-19-2014

Carelife re-passed the site inspection from ANVISA

 During March 31 to April 2, the health authority in Brazil (ANVISA) performed the GMP site inspection on Clindamycin HCl API manufactured by Chongqing Carelife (Carelife). And Carelife passed the inspection. During the audit, two auditors key points on the correction results of the deficiencies observed during the previous inspection and thoroughly inspect the situation of document system for QA in our company.

 

According to the audit agenda, two auditors with the company of leader and related persons inspected the manufacturing site in workshops, the documents system for QA,QC, especially, the import status of products, the validation on manufacturing process, the treatment system of purified water and HVAC system, the usage and maintenance of manufacturing equipment, and then the auditors put forward to the suggestions on how to meet the requirement of cGMP, which improves our understanding on GMP. The audit is conducted in the harmonious and communicated atmosphere. During the summary meeting, two auditors praised the good management on manufacturing and quality, and the  standard document system in our company, and presented the deficiencies observed during the inspection. The leaders in our company express they will pay close attention to the mentioned problems in the further work, make improvement on the deficiencies and similar problems on related products, and improve the GMP process continuously.

 

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