Concepts regardingConcepts regarding

GAMP GuideGAMP GuideBy Lorenzo BergaminiBy Lorenzo Bergamini

On behalf of

www.bli.it

IndexIndexIndexIndex

CContentsConcepts regarding Terms

Origin of GAMP Guide

G l V lid tiGuide General Validation Process Activities

Relationship

Acknowledgements

Creative CommonsCreative CommonsCreative CommonsCreative Commons

This document is provided under Creative Commons License.

If used, indicate the source:• Author’s name Lorenzo Bergamini• Author s name Lorenzo Bergamini

• On behalf of www.bli.it .

TermsTermsTermsTermsUser : the Customer who

Good Automated Manufacturing

PracticeGAMP

User : the Customer who contacts a supplier for a

product.Supplier : any

organization contacted di tl b th f

Subjects

directly by the user for supplying a product.

Good Manufacturing

PracticeGMP Prospective

validation.Concept

Any standard To produceAny standard, configurable, custom,

product or application.ObjectsTo produce

documented proof ensuring that all parts

of the equipment in question will work

correctly when used

Objective

correctly when used.

Origin of the GAMP GuideOrigin of the GAMP GuideOrigin of the GAMP GuideOrigin of the GAMP Guide

In the early 90’s, with the increased complexity of automated systems in the Pharmaceutical sector,

subsequently extended to the Biomedical, Chemical and q y ,Foodstuffs sector.

And the consequent need to improve understanding of the regulation and its interpretation.

The GAMP Forum, guided by David Selby, promotes this activity.

One of the priorities is to establish guidelines for suppliers of automated equipment to the above mentioned sectorsof automated equipment to the above-mentioned sectors.

GeneralGeneralGeneral Validation Process ActivitiesGeneral Validation Process Activities

Planning / Progettazione

Specification / Specifiche

Test Planning / Piano di Test

Testing / Test

Review / Revisione

GeneralGeneralGeneral Validation Process ActivitiesGeneral Validation Process Activities

PlanningPlanning

[progettazione][progettazione]

Written Validation Plan(Piano di Validazione).

GeneralGeneralValidation ProcessActivities

SpecificationsSpecifications

[specifiche][specifiche]

Specify and agree what is requiredSpecify and agree what is required.

GeneralGeneralValidation Process Activities

Test PlanningTest Planning IQ [installation qualification]

[piano di test][piano di test] PQ [performance qualification]

OQ [operational qualification]

Prepare document to describe how the system is to be tested.

General Validation ProcessGeneral Validation Process Activities

TestingTesting IQ [installation qualification]

[test][test] PQ [performance qualification]

OQ [operational qualification]

Perform tests and collect resultsPerform tests and collect results.

G l V lid tiGeneral ValidationProcess ActivitiesProcess Activities

ReviewReview

[revisione][revisione]

Review results to show that the system performs as specified plus any reservations.

RelationshipRelationshipRelationshipRelationshipThe three main Test documents can be related to the three basic levels of features of the system b ilt

UserUserRequirementsRequirements

Related toPerformancePerformanceQualificationQualification

built:

qqSpecificationsSpecifications Related to QualificationQualification

FunctionalFunctionalSpecificationSpecification

OperationalOperationalQualificationQualification

DesignDesignSpecificationSpecification

InstallationInstallationQualificationQualificationSpecificationSpecification QualificationQualification

SystemSystemBuildBuild

RelationshipRelationshipRelationshipRelationshipUserUserUserUser

RequirementsRequirementsSpecificationsSpecifications

PerformancePerformanceQualificationQualificationRelated to

User Requirements Specification (URS)

Describes what the system is

URS may be related to Performance

Q lifi ti (PQ)

An initial version is included in the

required to do and is normally written by the

User

Qualification (PQ), which controls the

system in its operating i t ith

Invitation To Tender (ITT), sent to potential

suppliers. The final version may be prepared b h l d liUser. environment, with

all the associated procedures.

by the selected supplier.

RelationshipRelationship

FunctionalFunctionalSpecificationSpecification

OperationalOperationalQualificationQualificationRelated to

Functional specification (FS)

It is normally written by the FS are related toAn initial version maysupplier and describes the

detailed functions of the

FS are related to Operational

Qualification (OQ), which controls all

the specific

An initial version may be produced in

response to the ITT. Further reviews are

prepared together withfunctions of the system.

the specific functions.

prepared together with the User.

RelationshipRelationship

DesignDesignSpecificationSpecification

InstallationInstallationQualificationQualificationRelated to

Design Specification (DS)

It is a complete fairly detailed

DS is related to Installation

Q lifi ti (IQ)Design specification ofdefinition of the system so that it

can be constructed

Qualification (IQ), which checks to

make sure the exact system is supplied,

di t th

Design specification of the system provided by

the product Supplier/Producer.

constructed. according to the required standards

and that it is installed correctly.

Qualification DocumentQualification DocumentQualification DocumentQualification DocumentP d tiProduction

The qualification document The supplier’s documentationThe qualification document can be produced

satisfactorily when a separate and complete

The supplier s documentation and checking procedures can

already satisfy the requirements of the IQ p p

specification already exists for the process or system

to which reference is made.

q Q(Installation Qualification), if

reviewed and approved by the User.

AcknowledgementsAcknowledgementsAcknowledgementsAcknowledgements

AcknoweledgementsAcknoweledgementsAcknoweledgementsAcknoweledgements

Concepts regardingConcepts regarding

GAMP GuideGAMP GuideBy Lorenzo Bergamini

Thank You!Thank You!By Lorenzo Bergamini

Thank You!Thank You!On behalf of

www.bli.it