1. QUALIFICATION & VALIDATION
Nur Fadillah, S.Farm 2012000165
Nur Sriati, S.Farm 2012000166
Nuryani, S.Farm 2012000167
Wiro Alexander Willy, S.Farm 2012000168
Yunia Wiraswati, S.Farm 2012000169
PROGRAM PROFESI APOTEKER
FAKULTAS FARMASI
UNIVERSITAS PANCASILA
JAKARTA
2012

2. RIV
Validation
DOCUMENTATION
PROCCES AND RESOURCE

3. QUALIFICATION
•Design Qualification
1
•Installation Qualification
2
•Operational Qualification
3
•Performance Qualification
4
•Qualification of Established (in-use) Facilities, Systems and
5 Equipment

4. Prospective
Validation
Concurrent
Validation
Retrospective
Validation
PROCESS VALIDATION

6. What
is it ?
CHANGE
CONTROL
How
to do ?

7. REVALIDATION

8. The objective
Validation of
an Analytical
Procedures
Types of Typical
Analytical validation
Procedures characteristic