Sinovac Beijing's QC Laboratory Accredited By CNAS
August 20, 2022, Beijing – Sinovac Biotech Ltd. (NASDAQ: SVA) ("SINOVAC" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that the Quality Control (QC) laboratory of its subsidiary Sinovac Beijing, has been accredited by the China National Accreditation Service for Conformity Assessment (CNAS), confirming the lab meets ISO 17025 global standards for operational competence and validity.
The certification (Registration No. CNAS L16860) is in accordance with ISO/IEC 17025 requirements for testing and calibration laboratories. The accreditation signals the Beijing Sinovac QC laboratory meets global industry regulations for quality and accuracy for 50 total parameters, to competently undertake services for six types of testing objects for biological products, prefilled syringe assembly and more.
In conferring the accreditation, CNAS' review committee assessed the QC laboratory's quality management system and testing capabilities for biological products and packaging materials. The committee unanimously certified the high standards of the laboratory's environmental conditions, organizational structure, personnel, equipment and operations of its quality management system. The committee confirmed that the QC laboratory met all application parameters.
The China National Accreditation Service for Conformity Assessment (CNAS) is China's national accreditation body unitarily responsible for the accreditation of certification bodies, laboratories and inspection bodies, established under the approval of the Certification and Accreditation Administration of the People's Republic of China (CNCA) and authorized in accordance with the Regulations of the People's Republic of China on Certification and Accreditation.
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the research, development, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A and B, seasonal influenza, pneumococcal disease, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella, mumps, and poliomyelitis.
SINOVAC's COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The Healive®, a hepatitis A vaccine manufactured by the Company, passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine, that was commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) was prequalified by WHO.
SINOVAC was the first company that granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied to the Chinese Government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC has been continually dedicating itself to new vaccine research and development, with more combination vaccine products in the pipeline, and constantly exploring opportunities in the international market. SINOVAC looks forward to conducting more extensive and in-depth trade and cooperation with more countries, enterprises, and professional institutions.
For more information, please see the Company’s website at www.sinovac.com.
Sinovac Biotech Ltd.