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Shineway Pharmaceutical Passes Australia TGA Re-audit Successfully


Shineway Pharmaceutical Passes Australia TGA Re-audit Successfully

(Reporter: Songnana, Gao Yanchang)From 25th to 28th July, Mr. Robert from Australia Therapeutical Goods Administration reviewed and validated Shineway’s medicine production and quality control as per PIC/S2009 of latest Australia GMP standard. After four day’s tight and organized audit, Shineway passed TGA audit successfully, and would obtain renewal TGA certificate, which showed that Shineway’s GMP management standard is up to GMP international level.

In validation, Mr. Robert reviewed corrective actions for last audit and spoke highly of quality control system, capability of testing, and logistics management. The validation scope included granules, tablets, soft capsules, oral liquid, hard capsules, dripping pills etc. In the closing meeting, Mr. Robert thanked for Shineway’s hospitality, gave high praise on quality control, production management and equipment management, and proposed valuable advices on products recall, material identification management and testing on purified water, which would facilitate Shineway with improvement of GMP management standard.(Translator: Chen Liwei)


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