Supplier Checklist for Audit（供应商审计检查清单英文版）.docVIP

CHECK LIST PAGE PAGE 1 August 2011 Ref . ICH Q7A; CEFIC/APIC Auditing Guide; Check List Raw materials RX-360 FACTORY ______________________________________________________________________________ PRODUCT ______________________________________________________________________________ DATE ________________________________________AUDITOR ____________________________________ ORGANIZATION Organization chart of personnel Quality Unit Presentation Hard Copy Certification GMP, ISO, Safety, Environmental ,Others Customer Audit Number of personnel employed in the factory Total production :_____________________ QC :_____________________ QA :_____________________ laboratory :_____________________ warehouse :_____________________ maintenance service :_____________________ other :_____________________ Turnover last 2 years 2009:_______ 2010:_______ % FIS products on the total turnover Capacity for the intermediate N# of Batch /day: Quantity per batch: Capacity /month Max Q /Year: General overview of manufacture: See 15, 16 page 3 Facilities square meters n°equipments/ vol n°processes/ type Organization of the work: No.days/week __________ No. Hours/day__________ No. Shifts/day__________ Instruction for shift : Management of responsibility Quality responsibility are in writing ? Document Management: See also page 10 –QA System-Documentation list of SOP available ? FACILITIES TOUR WAREHOUSE OF RAW MATERIALS AND OF INTERMEDIATES General Overview Well maintained, no broken or leaking containers ? Open or protected ? Presence of traps /Insects/ Birds ? Temp mapping ? Receiving Raw materials Solvents Packaging material Labels Returned goods Storage (general)- separation of raw material (chemical incompatibility; approved, rejected and quarantine material,) ? Lot numbering system: how raw materials and intermediate are identified? How is lot number assigned ? Quarantine Physical separation ? Does the labelling allow to distinguish between ap