COMMISSIONING

&

QUALIFICATION

From Design to Operation Phases….

E. CHEVAILLIER

in Pharmaceutical Industry

Commissioning & Validation Master Plan

C o m m i s s i o n i n g P l a n V a l i d a t i o n M a s t e r P l a n

E. CHEVAILLIER

O&M Training - SOP

Test Climatique

O&M Manuels

Support Technique

Planning QI/QO

SCADA & Intégration

Rapports QP

Protocoles et Fiches de Tests

System Readiness

CalibrationFine-tuning

Protocoles QI/QO Données critiques

Rapports QI/QO

Plan Stabilité de performance

SAT

Change and Impact Control

QO Readiness

Commissioning & Qualification Scope

C o m m i s s i o n i n g P l a n V a l i d a t i o n M a s t e r P l a n

Procédure-Planning Energisation

E. CHEVAILLIER

Commissioning & Validation Master Plan

E. CHEVAILLIER

Commissioning & Qualification Decision Chart

System 1

SystemDirectly

Impacts on Product Quality

?

Componentis DirectlyACTIVE on

Processparameters

?

Sub-system 1.1

Component 1.1A

Component 1.1B

Component 1.1 #

NONGMP

Component is a SENSOR

?

Calibrate

IQ/OQ

NO YES

YES

YES

NO

COMMISSIONING

QUALIFICATION

E. CHEVAILLIER

Commissioning & QualificationOrganisation par Unité Fonctionnelle

E. CHEVAILLIER