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Examples of Observations in GMP Compliance …

Examples of Observations inpGMP Compliance Inspections,and Related Problemsand Related Problems(Manufacturer/Market Authorization Holder/In-tC tk fMFEt)country Caretaker of MF, Etc.)Office of GMP/QMS inspection,Office of GMP/QMS inspection,Pharmaceuticals and Medical Devices AgencyCPhI J2013 CPhI Japan 2013 April 25, 2013 Tokyo Big Sight* The slides in Japanese are the official 's agendaToday s agenda21. Introduction (the main topic for today)2. Overview of GMP on-site inspections by the PMDApy3. Cases of non- Compliance in recent GMP Compliance inspectionsinspections4.

2. Overview of GMP on-site inspections by the PMDA 3 000 [Accreditation of foreign manufacture rs: Totals by fiscal year and area] Fiscal 2008 – …

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  Foreign, Manufacture, Accreditation, Accreditation of foreign manufacture rs

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