HJB - Your Trusted Biologics CDMO Partner

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HJB - Your Trusted Biologics CDMO Partner


Quality Assurance - Compliance Highest, Quality First

  • Quality Management System: HJB has developed an integrated and comprehensive quality management system that meets ICH, US Food and Drug Administration (FDA), European Medicines Agency (EMA) and China National Medical Products Administration (NMPA) Good Manufacturing Practice. It enables us to make a comprehensive quality oversight and management on drug manufacturing and routine operation. In the premise of compliance, successively improve the product process, quality, establish good Client service mindset, and improve the quality of Client service to make sure the satisfaction of Client.

  • Validation Management: Validation covers all the phases of drug lifecycle. HJB has built an experienced validation team and established a thorough validation management system including Validation Master Plan, Project Validation Plan, Validation sub-plan, Validation and Qualification Standard Operation Procedure, Validation Implementation Plan,Validation Reports, Re-validation etc. A comprehensive validation system documents are covered, including URS, SIA, RA, FS, DS, DQ, FAT, SAT, IQ, OQ, PQ, RTM etc.

  • Shopfloor Oversight: Provide overall quality oversight across the product manufacturing to assure the delivery of high quality product.