YaoPharma passed GMP Inspection from Health Canada

01 / 12 / 2010

Since 2008, YaoPharma has invested RMB 200 million to implement the long brewed internationalization strategy. A cGMP project team is specially set up, with Chairman Liu Qiang being the project leader, President Wang Fan and Vice President Ha Qing directly responsible for cGMP upgrade. The company has introduced first-class international production equipments from Germany and Italy, rebuilt an automatic warehouse in accordance with cGMP requirements, remodeled workshops and facilities, and at the same time actively improved software level, and introduced senior management and technical talents from overseas and from famous global pharmaceutical giants, and strengthened cGMP training to workers at the production line. The documentation system and audit method gradually meet the GMP standards of developed countries.

 

On October 18, 2010, after two years’ upgrade, YaoPharma received the six-day site inspection conducted by Health Canada. The company has already invited GMP experts at home and abroad in advance to carry out on-site simulating inspections and related trainings, and made careful analysis and improvement to the deficiencies observed. Owing to the great attention the company has paid and the full preparation, and joint efforts of all the staff, YaoPharma successfully passed the site inspection. It means that YaoPharma has fully complied with Canadian GMP in the aspects of the facilities, equipment, environment, personnel, documentation system and quality management system, etc., the products manufactured will satisfy the quality requirements of the western mainstream medical market.

 

It is reported that YaoPharma is the first pharmaceutical manufacturer of finished dosage forms which passed Health Canada GMP inspection. Meanwhile, with Canada being one of the GMP mutual recognition agreement countries with the European Union, Australia and New Zealand and a member country of PIC/S, YaoPharma passing the Canadian GMP inspection, also means that it opened the first door to the 28 PIC/S countries. It enabled YaoPharma to accumulate valuable experience in accepting the further GMP inspection by other western countries, and laid a solid foundation for its internationalization. It was the first battle to overcome in the process of entering international pharmaceutical market.