Transcription of Example Sample1 Manufacturing process flow.
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Example Sample1 Manufacturing process flow.
0 Sample1 Manufacturing process VisualInspection (Qualityconformanceinspection) Injectionmoldingprocess Visual Inspection)(Electric resistance measurement ) Weldingprocess Coating Cleaning / Packaging / 2 Visual Inspection)(Leakage current measure) Cleaning Sterilizedpackagingprocess VisualInspection Bioburdentesting Sterilization (EOG (BItesting)(Determinationofresidualethyl eneoxide) (Visual Inspection)StoragePackaging / LabelingFinal VisualInspection 5 Visual Inspection Decision on whether the products an be raw material from supplier and Mutual relations of QMSABC Mfg. site(Registration)Main assembling plantMNO, Co.(Registration)Design facilityDEF, Mfg. site(Registration) Sterilizer JKLD istribution Center(Registration) Distribution Center STU, Mfg. plantGHI Distribution Center Inspection Storage QMS(ABC, Co. QMS(DEF, Co.) Same QMSA greement InformationexchangeAgreementExampleMarke ting Authorization Holder JKL, Ltd.
(common name), Proprietary name Copy of marketing approval 2.The date of number of approval Copy of marketing approval 3.Specifications Product Specification (P2/D2 DMF1 device requirement spec 73345) 4.Operating methods and procedure Product Manual 7233 5.Product design, drawings and specifications or composition and content Mechanical ...
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