GMP Inspection report - Wil-Zone

Wil-Zone CONSULTINGGMP Inspection report - 1 -GMP Inspection reportInspected site(s):Activities Carried out:qManufacture of Active SubstanceqManufacture of Finished Medicinal Product PackagingqImportingqLaboratory TestingqBatch Control and Batch ReleaseqOther: .. Inspection date(s):.Name of the inspector(s) Vilmos Ber nyi Organization:Name of expert / assessor (if applicable)Short description of the company and the activities of the companyqSite master file was available before/during the inspectionoDate of the site master file:oIssued by:qSMF assessed, comments:GMP-related recalls from the market of any product in the last CONSULTINGGMP Inspection report - 2 -Date of previous Inspection :Major changes since the previous Inspection :Brief report of the Inspection activities undertaken:Scope of Inspection :qProduct related Inspection (.. Active Substance)qGeneral GMP inspectionqOther:..Inspected area(s): Wil-Zone CONSULTINGGMP Inspection report - 3 -Personnel met during the Inspection :Inspector s findings and observations:qQuality ManagementqPersonnelqPremises and EquipmentqDocumentationqProductionqQuali ty ControlqContract Manufacture and AnalysisqComplaints and Product RecallqSelf InspectionqQuestions from the Assessment of the ApplicationqInvestigation of Product Recall or Product DefectComments: Wil-Zone CONSULTINGGMP Inspection report - 4 Quality assurance(a)Quality system and documented qual

WIL-ZONE CONSULTING GMP Inspection report - 4 - E.1 Quality assurance (a) Quality system and documented quality policy of the manufacturer, e.g. as described in the

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