bli.it concepts-regarding-gamp-guide-en
DESCRIPTION
BLI.IT present Concepts Regarding Gamp GuideTRANSCRIPT
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