QUALIFICATION & VALIDATION

Nur Fadillah, S.Farm 2012000165Nur Sriati, S.Farm 2012000166Nuryani, S.Farm 2012000167Wiro Alexander Willy, S.Farm 2012000168Yunia Wiraswati, S.Farm 2012000169

PROGRAM PROFESI APOTEKERFAKULTAS FARMASI

UNIVERSITAS PANCASILAJAKARTA

2012

Validation

RIV

DOCUMENTATION

PROCCES AND RESOURCE

Principles

1 •Design Qualification

2 •Installation Qualification

3 •Operational Qualification

4 •Performance Qualification

5 •Qualification of Established (in-use) Facilities, Systems and Equipment

QUALIFICATION

PROCESS VALIDATION

Retrospective

Validation

Concurrent Validation

Prospective

Validation

What is it ?

Why we need ?

CLEANING VALIDATION

How to do ?

CHANGE CONTRO

L

What is it ?

How to do ?

Changes in the synthesis of the drug substance

Changes in the composition of the finished product

Changes in the analytical procedure

REVALIDATION

Validation of an

Analytical Procedures

The objective

Typical validation

characteristic

Types of Analytical Procedures

THANK YOU