02/11/15 1

Q&VConcept & Terminology

Prepared by: M Luqman Ikram

Assistant Manager Validation

Prepared by: M Luqman Ikram

Assistant Manager Validation

02/11/15 2

Qualification & ValidationQualification & Validation

EquipmentEquipment11

EquipmentEquipment11

SystemSystemAA

SystemSystemAA

EquipmentEquipment22

EquipmentEquipment22

SystemSystemBB

SystemSystemBB

EquipmentEquipment33

EquipmentEquipment33

EquipmentEquipment44

EquipmentEquipment44

Process Process Process Process

Qualificati on

Qualificati onV

alidationV

alidation

Validation

Validation

&&

Qualification is a part of validation

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Definition:

Action of proving and documenting that the premises,

system & equipment are properly installed, and or work

correctly and lead to expected result.

QualificationQualification

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Validation

Definition:

Action of proving and documenting

that any process, procedure or

method actually and consistently

leads to the expected results.

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Validation Project

System Build / Implementation System Build /

Implementation

PlanningPlanningVMP

SpecificationSpecificationURS

FS

VerificationVerification PV/PQ

IQ

OQ

DS/DQ

FAT SAT

ReportingReporting

Summary & Recommendation

Final Report

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Validation Master PlanValidation 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

QualificationQualification ValidationValidation

Validation Master PlanValidation Master Plan

Process Process ValidationValidation

CleaningCleaning Validation Method Validation

EquipmentEquipmentPremisesPremises Systems/ Utilities

02/11/15 7Change ControlChange Control

Planning & SchedulingPlanning & Scheduling

Required SOP'sRequired SOP's

Documentation FormatDocumentation Format

Key Acceptance CriteriaKey Acceptance Criteria

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

Validation Approach (Prospective, concurrent, Retrospective, Revalidation) Validation Approach (Prospective, concurrent, Retrospective, Revalidation)

Plant / Process / Product DescriptionPlant / Process / Product Description

Organizational Structure of All Validation ActivitiesOrganizational Structure of All Validation Activities

Introduction & Firm's validation policy, Introduction & Firm's validation policy,

Specific Process Considerations (Critical Point of process)Specific Process Considerations (Critical Point of process)

VMP Format & contents

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USER required specificationUSER 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:

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

Functional & Operational requirement

Regulatoryrequirement

Migration of any electronic data

CostMaintenance requirement

EH&S requirement

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functional Specification functional Specification

Definition:

The Functional Specification

describes the detailed operation

of the equipment, from which an

OQ test plan can be constructed.

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Design Specification Design Specification

Definition:

The Design Specification usually

consists of the electrical

schematics, part descriptions, and

the detail required to construct the

system. from which an IQ test plan

can be constructed.

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Factory Acceptance TestFactory Acceptance Test

Factory Acceptance Test (FAT):

is a test conducted at the

Vender’s premises, usually by a

third party, to verify that the

System, Equipment operates

according to the specifications.

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

SITE Acceptance TestSITE Acceptance Test

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Design QualificationDesign Qualification

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

have been designed in accordance with the requirement of GMP.

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Installation Qualification

I.Q

Documentation & Identification

Peripheral equipments

Utilities Maintenance & Lubrications

CalibrationTraining Safety

feature

Evaluation of Machine

motor

Definition The 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 SpecificationDesign Specification

Verify

Installation QualificationInstallation Qualification

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Operational QualificationOperational Qualification

Definition:The documented verification that the system or

subsystem performs as intended over all anticipated operating ranges.

Control function Test Operational test

O.Q O.Q

Functional SpecificationFunctional SpecificationVerify

Operational QualificationOperational Qualification

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Process/Performance QualificationProcess/Performance Qualification

Definition

The documented verification that the facilities,

systems and equipment operate consistently and

gives reproducibility within define specification

and parameter for prolong period.

Or

Confirming that the manufacturing process as

designed is capable of reproducible commercial

manufacturing. (FDA)

URSURS

Verify

PQPQ

Excellent

Good

Too Much Variation

SpecificationUSL LSL

SpecificationUSL LSL

SpecificationUSL LSL

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A condition or set of conditions encompassing upper and

lower processing limits and circumstances, within SOP,

which pose the greatest chance of product or process

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)

Worst Case ScenariosWorst Case Scenarios

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ProtocolProtocol

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.

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report report

Report:

A document in which the records,

results & evaluation of a completed

validation / Qualification programme

are assemble & summarized. it may also

contain proposal for improvement of

process, System and/or Equipment.

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ProspectiveProspectiveNew Product/process/system/ Equipment

New 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 /Qualification

Type of ValidationType of Validation

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A formal system by which qualified

representatives of appropriate

disciplines review proposed or

actual changes that might affect

the validated status of facilities,

systems, equipment or processes.

Change control

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STAGE 01

Process Design

Based on product

Quality & patient safety

Know the process

Know the Variable

Have the confidence Vigilance

1. Process Understanding

1. Process Understanding

2. Process Design

2. Process Design

3. Process Qualification

3. Process Qualification

4. Commercial Manufacturing

4. Commercial Manufacturing

5. Monitoring & Improvement

5. Monitoring & Improvement

Change Control Change Control

Process Validation

STAGE 02Process

Qualification

STAGE 03Continue process

verification

02/11/15 23

thanks

Again Again

ThanksThanks