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Quality, EHS, and IP

Quality

•  At PharmaBlock, quality is more than a set of rules, it's what we believe in

•  GMP compliant at Zhejiang Site (FDA inspected with no Form 483s issued); NMPA PAI at Zhejiang Site(no critical/major findings);  ISO9001 certified at other sites

•  SOPs are developed based on ICH Q7, covering the entire quality system at manufacturing sites

•  Passed a number of client audits from top pharmaceutical and biotech companies and third party authorities


EHS

•  Our strong commitment to the environment, health, and safety underpins all that we do at PharmaBlock

•  Integrated safety and health management system (OHSAS18001), environment management system (ISO14001) and process safety management (PSM)

•  Passed a number of client audits from top pharmaceutical and biotech companies and third-party authorities, and set benchmark in each of the industrial park where PharmaBlock is located in

•  Optimal route design for better PMI control

•  Strict process and equipment management, along with scientific waste treatment and recycling use for cleaner production

•  New technologies application for greener and more efficient process and manufacturing

•  Process safety assessment for intrinsic safety. One of the first CDMO process safety labs certified by CNAS

•  Corporate-wide efforts and lean operation for energy savings and emission reduction


IP Protection

•  IP protection is an integral part of our business strategy to maintain our technological edge in the industry, and to maintain our long term trust and partnership with global clients

•  National standard GB/T29490-2013 implemented

•  Comprehensive strategy and practices are implemented, covering employee management, project management, information management, supplier management, and material management 

•  Audited by a number of global pharmaceutical companies

•  ISO/IEC 27001:2013 (Information Security Management System Certification ) certified