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Kualifikasi dan validasi
 

Kualifikasi dan validasi

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    Kualifikasi dan validasi Kualifikasi dan validasi Presentation Transcript

    • QUALIFICATION & VALIDATIONNur Fadillah, S.Farm 2012000165Nur Sriati, S.Farm 2012000166Nuryani, S.Farm 2012000167Wiro Alexander Willy, S.Farm 2012000168Yunia Wiraswati, S.Farm 2012000169 PROGRAM PROFESI APOTEKER FAKULTAS FARMASI UNIVERSITAS PANCASILA JAKARTA 2012
    • RIV Validation DOCUMENTATIONPROCCES AND RESOURCE
    • QUALIFICATION •Design Qualification1 •Installation Qualification2 •Operational Qualification3 •Performance Qualification4 •Qualification of Established (in-use) Facilities, Systems and5 Equipment
    • Prospective Validation Concurrent Validation Retrospective ValidationPROCESS VALIDATION
    • What is it ? CHANGE CONTROL Howto do ?
    • REVALIDATION
    • The objective Validation of an Analytical Procedures Types of Typical Analytical validationProcedures characteristic