BOC Sciences has built up a cGMP complied quality system to assure the quality of CMO services and products for our clients.
• Scale up and GMP certified manufacturing facilities can meet strict quality requirements and audit criteria;
• cGMP Plant facilities built to ICH standards
• SOP working standards
• QC: Equipped with state-of-the-art analytical instruments: HPLC, GC, Mass, Melting Point Meter, NMR, Prep-LC, dissolution bath, UV，SFC Prep-LC and more.
• QA: Our Quality assurance (QA) personnel trains our employees intensively and we established hundreds of SOPs guiding our GMP related activities , from raw materials to final products, from laboratory to pilot plant, from operator to chief executive officer.
• Vendor qualification and contract manufacturer qualification
• Quality incident management, including deviation, OOS, customer complaint, and product recall
• Internal audit and routine inspection