07 July 2012 1

Q&VConcept & Terminology

Well Come to Validation 

Team & Review Board 

Presented by: M Luqman Ikram

07 July 2012 2

Qualification & Validation

EquipmentEquipment11

SystemSystemAA

EquipmentEquipment22

SystemSystemBB

EquipmentEquipment33

EquipmentEquipment44

Process  Process  

Qualification

QualificationV

alidationValidation

Validation

Validation

&&

Qualification is a part of validation 

07 July 2012 3

Qualification

Definition:

Action of proving and doc

umenting that the premises, 

system & equipment are properly installed, 

and or work 

correctly and lead to expe

cted result.

07 July 2012 4

Validation

Definition:

Action of proving and documenting that

any process, procedure or method

actually and consistently leads to the

expected results.

07 July 2012 5

Validation Project

System Build / Implementation 

PlanningVMP

SpecificationURS 

FS 

Verification PV/PQ

IQ

OQ

DS/DQ

FAT SAT

Reporting

Summary & Recommendation

Final Report

07 July 2012 6

Validation Master Plan

Definition

A Validation Master Plan is a document that

summarizes the firm's overall philosophy,

intention and approach to be used for

establishing performance adequacyperformance adequacy

Qualification Validation

Validation Master Plan

Product/Process                             Product/Process                             Cleaning procedure Cleaning procedure 

Computer System                 Computer System                 Analytical Analytical Method

EquipmentEquipmentPremisesPremisesSystems/ Utilities

07 July 2012 7

VMP Format & contentsIntroduction & Firm's validation policy, 

Organizational Structure of All Validation Activities

Plant / Process / Product Description

Specific Process Considerations (Critical Point of process)

List of Products/Processes/ Systems/Equipment to be Validated 

Validation Approach (Prospective, concurrent, Retrospective, Revalidation) 

Key Acceptance Criteria

Documentation Format

Required SOP's

Planning & Scheduling

Change Control

07 July 2012 8

USER required specification

Definition

A document stating the specified 

user requirement for a select piece 

of equipment, System or Facility. 

The contents of a URS typically include, but are not limited to the following:

Functional &Operational requirement

Regulatoryrequirement

Migration of any electronic data 

CostMaintenancerequirement

EH&S requirement

07 July 2012 9

functional Specification

Definition:

The Functional Specification 

describes the detailed operation of 

the equipment, from which an OQ 

test plan can be constructed.

07 July 2012 10

Design Specification

Definition:

The Design Specific

ation usually 

consists of the elec

trical 

schematics, part descripti

ons, and 

the detail required

 to construct the 

system. from which an IQ test pl

an 

can be constructed

. 

07 July 2012 11

Factory Acceptance Test

Factory Acce

ptance Test (F

AT):

is a test cond

ucted at the 

Vender’s pre

mises, usually b

y a 

third party, to

 verifythat th

e 

System, Equip

ment operates

 

according to 

the specificati

ons.

07 July 2012 12

SITE Acceptance Test

SAT: Site Acceptance TestEquipment testing done at the Final operational site. or Executed with the customer on site.

07 July 2012 13

Design Qualification

Definition:The documented evidence that premises, supporting system, utilities, equipment & process

have been designed in accordance with the requirement of GMP.

07 July 2012 14

Installation Qualification

I.Q

Documentation & Identification

Peripheral equipments

Utilities  Maintenance & Lubrications

CalibrationTraining Safety feature

Evaluation of Machine motor 

DefinitionThe performance of test to ensure that the installation 

(such as machine, measuring device, utilities, manufacturing area) used in manufacturing process are appropriately selected and correctly installed & operate in accordance with establish specification.

Design Specification

Verify

Installation Qualification

07 July 2012 15

Operational Qualification

Definition:The documented verification that the system or 

subsystem performs as intended over all anticipated operating ranges.

Verify

Operational QualificationFunctional Specification

Control function Test  Operational test 

O.Q 

07 July 2012 16

Process/Performance Qualification

Definition

The documented verification that the facilit

ies, 

systems and equipment operate consistently and 

gives reproducibility within defin

e specification 

and parameter for prolong period.

Or  

Confirming that the manufacturing process as 

designed is capable of reproduci

ble commercial 

manufacturing. (FDA)

URS

Verify

PQ

Too Much Variation

SpecificationUSL LSL

Good

SpecificationUSL LSL

Excellent

SpecificationUSL LSL

07 July 2012 17

Worst Case Scenarios

A condition or set of conditions encompassing upper and 

lower processing limits and circumstances, within SOP, 

which pose the greatest chance of product or pr

ocess 

failure when compared to ideal conditions. Such 

conditions do not necessarily induce product or 

process 

failure.

(e.g. start‐up after shutdown, temperature recovery 

time, Autoclave largest load, or largest mass)

07 July 2012 18

Protocol

Protocol:

A document that spells out

what tests are to be

performed, how the tests are

to be performed, what data are

to be collected, and what the

accep-tance criteria are.

07 July 2012 19

report

Report:

A document in w

hich the records

, 

results & evaluati

on of a completed 

validation / Qual

ification program

me

are assemble & su

mmarized. it may also 

contain proposal 

for improvement of 

process, System and/or E

quipment.

07 July 2012 20

Type of Validation

ProspectiveNew Product/process/system/ Equipment

Routine Product/Process/system /equipmentConcurrent

Review and analysis of historical DataRetrospective

Repetition of the Qualification/validation process or a specific portion of it. Re‐Validation /Q

ualification

07 July 2012 21

Change control

A formal system by which qualified 

representatives of appro

priate 

disciplines review propos

ed or 

actual changes that might affect 

the validated status of fac

ilities, 

systems, equipment or processes.

07 July 2012 22

Process Validation

STAGE   01

Process Design

STAGE   02Process 

Qualification

STAGE   03Continue process 

verification

Based on product  

Quality & patient safety 

Know the process

Know the Variable

Have the confidence Vigilance

1. Process Understanding         

2. Process Design

3. Process Qualification

4. Commercial Manufacturing

5.  Monitoring & 

Improvement

Change Control 

07 July 2012 23

thanks

Again Again

ThanksThanks