The Quality Control Department of WIBP adheres to the working principle of "objectivity, fairness, science and accuracy", strictly follows ISOIEC17025, and establishes quality management documents, quality control system, laboratory internal audit and management evaluation system in line with international standards from six aspects: people, machines, materials, methods, environment and measurement. In June 2017, it obtained the laboratory accreditation certificate issued by the China National Accreditation Service for Conformity Assessment (CNAS). The team works in the laboratory is professional, with reasonable structure, rich experience and first-class quality. The laboratory conforms to GMP requirements and CNAS concepts, and it has more than 400 advanced testing instruments and equipment. It’s engaged in bacteria and virus cell bank, pharmaceutical water, raw and auxiliary materials and packaging materials, intermediate products, finished products, clean room environment validation and monitoring, etc., ensuring that the quality and standards of the testing are in stringent accordance with Chinese Pharmacopoeia and relevant laws and regulations.
[CNAS Accredited Testing Items]
1.Biological products: RFFIT, toxicity reversion, specific toxicity, toxoid floccule unit, bacterial endotoxin, abnormal toxicity, identification of virus seeds, antibiotic residue, intracerebral pathogenicity, reverse mutation test in suckling mice, reverse transcriptase assay, etc.
2.Packaging materials for pharmaceutical products: acute systemic toxicity test, determination and classification of hydrolytic resistance of inner surface at 121 ℃, determination and classification of hydrolytic resistance of glass grains at 121 ℃, pyrogen test, etc.
3.Drugs: light transmittance, absorbance, relative density, melting point, optical rotation, pH value, protein content, chloride, sulfate, iron salt, heavy metal, arsenic salt, ammonium salt, weight loss on drying, ignition residue, easy carbonization, total organic carbon, conductivity (pharmaceutical water), solution color, etc.
[Contact Us]
Contact person: Ms. Shi
Tel:027-86634028
E-mail:shiyanhong1@sinopharm.com