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PR Kaiyuan passed on-site GMP inspection

2021-02-10 11:35:30

In November 2020, People’s Republic of China (Liaoning) Drug Administration conducted an on-site GMP inspection against PharmaResources (Kaiyuan) Co., Ltd., refer to Ticagrelor API production.

 

The purpose of this inspection is to verify whether the company's quality management system meets GMP standard, and the system is continuously effective.The inspection team concluded that the system is appropriate, sufficient and effective, it is in compliance with the GMP standard for Pharmaceutical products (Version 2010)”.

 

In January 2021, PharmaResources (Kaiyuan) passed the EU Written Confirmation on-site inspection, and successfully ceritified, which indicates that the production facility complies with the requirements of the Chinese GMP Standard (equal to GMP of EU, WHO/ICH Q7).

 

Successfully passing of these inspections means PharmaResources has moved forward to a new stage. PharmaResources will continuously strengthen the quality management system to practice the philosophy of customer focus and quality first.

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