QUALIFICATION & VALIDATIONNur Fadillah, S.Farm           2012000165Nur Sriati, S.Farm             2012000166Nuryani, S.Far...
RIV Validation       DOCUMENTATIONPROCCES AND RESOURCE
QUALIFICATION    •Design Qualification1    •Installation Qualification2    •Operational Qualification3    •Performance Qua...
Prospective                       Validation  Concurrent  Validation               Retrospective                Validation...
What    is it ?              CHANGE              CONTROL Howto do ?
REVALIDATION
The objective              Validation of              an Analytical               Procedures Types of                     ...
Kualifikasi dan validasi
Kualifikasi dan validasi
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Kualifikasi dan validasi

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Kualifikasi dan validasi

  1. 1. 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
  2. 2. RIV Validation DOCUMENTATIONPROCCES AND RESOURCE
  3. 3. QUALIFICATION •Design Qualification1 •Installation Qualification2 •Operational Qualification3 •Performance Qualification4 •Qualification of Established (in-use) Facilities, Systems and5 Equipment
  4. 4. Prospective Validation Concurrent Validation Retrospective ValidationPROCESS VALIDATION
  5. 5. What is it ? CHANGE CONTROL Howto do ?
  6. 6. REVALIDATION
  7. 7. The objective Validation of an Analytical Procedures Types of Typical Analytical validationProcedures characteristic

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