Transcription of Examples of Observations in GMP Compliance …
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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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Application for Accreditation of, Application for Accreditation of Foreign Manufacturers, Pharmaceutical Regulations in Japan, Accreditation of foreign, LIST OF APPROVED FOREIGN HALAL, Credentialing, Accreditation, Regulation System of Veterinary, Regulation System of Veterinary Medicinal Products, Vendor registration form