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Corporate headquarters and R&D facility located in the Beijing University Biological Industry Park, Haidian District, Beijing, China. Of the 4,500sqm facility, over 2,000sqm are used for the Hepatitis A and Hepatitis A&B vaccine production plant.
Second 4,300sqm facility located in Tangshan, Hebei, China, where the Company is conducting research and pilot-production for the vaccines that are still in development Plants for Hepatitis vaccines have been developed and validated by European companies according to European safety standards.
World Advanced GMP Quality Assurance System
Quality Assurance System (QAS) of Sinovac is fully complied with international standard on Bio-Pharmaceutical management. The design of the plant of Healive vaccine was done by a well-known European company in accordance to the U.S. FDA and EU GMP requirements, with major equipment and facilities imported from Europe, and the installation and debugging processes completed in a key-handing-over way by an European pharmaceutical engineering company. It has passed the validation done by SVS---a FDA designated GMP validation consulting company.
The Sinovac manufacturing plant for Inactivated Hepatitis A vaccine has obtained the GMP certificate issued by the State Food and Drug Administration (SFDA) in March 2002.
According to FDA GMP requirements, Sinovac has edited major validation plan and a complete documentation system. In addition, Sinovac has strict control management on working staffs, plant environment, facilities, raw materials, hygiene, validation, documentation, manufacture process, quality control, product selling, post selling pharmacovigilance, and we have timely training to staffs so that to guarantee a finely running of the whole quality assurance system and the quality of the finished products.
The international standards for the construction of manufacturing workshop:
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FDA, TITLE 21, Code of Federal Regulations(21 CFR), Parts 210&211. |
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European Commission. Volume 4: Medicinal products for human and veterinary use: Good manufacturing practices. |
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Food and Drug Administration “Guidance for Industry, Analytical Procedures and Methods Validation” (Draft Guidance), August 2000. |
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United States Pharmacopoeia, USP 24, Validation of compendial methods<1225>. |
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A WHO Guide to Good Manufacturing Practice (GMP) requirements. |
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Guide for inspection of manufacturers of biological products. |
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