Validation Change Control Maintaining The Validate State-09-2015.pptx

7/24/2019 Validation Change Control Maintaining The Validate State-09-2015.pptx

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DA Guidance #o Industry

/anuary 11 #hree Stages o( Process !alidation

Process Design Stage *process is de(ined 'ased

on development and scale2up- Process Per(ormance 8uali(ication *PP8- Stage

*Design is con(irmed as 'eing capa'le o(reproduci'le production-

Continued !eri(ication and improvement*Continuously gaining assurance the processremains in a validated state o( control-


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Im!ortance of Change Control

%ot to prevent change.

#o control and document change.

3e)uired 'y the regulations. Identi(y GBP and validation implications.

Ascertain process remains in a state o(

control. Bust 'e implemented using a procedure.


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Controlling Change

Eow to maintain a validated?)uali(ied state a(terchange *implementing change control- &valuate (or impact on GBP compliance.

&valuate (or impact on validation. nowledgea'le assessment o( re)uirements to maintain

compliance and validation *commensurate with ris@level-.

Develop plan to implement re)uirements.

Implement re)uirements and maintain a compliant andvalidated system.

Bonitor to ensure change gave intended result and didnot introduce une:pected issues


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#he AS#B &


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Process !alidation General

Principles and Practices Guidance to industry issued 'y the DA in

/anuary 11. $utlines the li(e cycle approach to validation. Inline with the principles advanced in ICE 85,

ICE 84, ICE 81 and in AS#B &


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DA Guidance to Industry

/anuary 11 #hree Stages o( Process !alidation

Process Design Stage *process is de(ined 'ased on

development and scale2up- Process 8uali(ication Stage *Design is con(irmed

as 'eing capa'le o( reproduci'le production-

Continued !eri(ication and improvement

*Continuously gaining assurance the processremains in a state o( control-


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#he "i(e Cycle Approach to Process

!alidationPlanning

Design *ICE 85-

Implementation

8uali(icationContinuous

!eri(ication

Improvement

ICE 84

ICE 84, CAPA, PA#

Change Control

PA#

ICE 81

#he 8uality System


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Stage 1 Process Design

Fnderstanding the science

Fnderstanding the ris@ uilding 8uality into the process

&sta'lishing Control Strategy


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Stage Implementation and Process

8uali(ication

8uali(ication o( utilities and e)uipment Process Per(ormance 8uali(ication *PP8-

protocol

Protocol e:ecution and report


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Stage ; Continued Process

!eri(ication*ensure process remains in a validated state o( control-

Bonitoringappropriate parameters to ensure

process in a state o( control.

Fse CAPA, PA# and change control as well asdata collected in monitoring to maintain the

validated state and continually improve the

process. Proper maintenanceo( the (acility, utilities, and

process e)uipment


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Stage ; o( Guidance Stipulates

Process must remain in a state o( control *or in the8uali(ied?validated State-

#his is accomplished 'y veri(ying that it is, through a systemto detect unplanned departures *monitoring-.

I( trends are o'served, then you must ta@e action to correct.&very time you ta@e action to correct *e.g. PA#, CAPA- youmaintain the validated state and you are improving theoperation.

Fse Statistics to identi(y trends and review such using SB&.

8uality unit to review the in(ormation.

Fse data collected to identi(y ways to improve process.


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Stage ; o( Guidance Stipulates

8uality unit to meet with manu(acturing periodicallyto evaluate data.

Bonitor 'eyond process parameter *e.g complaints,

$$S, deviations, etc.-. Fse data collected to identi(y ways to improve

process.

Baintenance o( the (acility, utility and e)uipment is

o( critical importance (or maintaining the validatedstate.


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Bonitoring

%eed to @now the right Critical 8uality

Attri'utes *C8As- o( product

%eed to @now the Critical ProcessingParameters *CPPs- which a((ect C8As

Bonitor the CPPs and C8As

Insure you ta@e actions when you see adeviation or o'serve a trend.



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Data (rom varia'le 'eing monitored should con(orm to a

random pattern around the target value, and should 'e within the

action limits to indicate that the system?process?condition is

under control.

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Action "evel

Alert "evel

Alert "evel

Action "evel

Time

2unction

eing

Monitored

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ailure

#arget !alue


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Monitoring ensures trends to+ards failure are identified

in time

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Action "evel

Alert "evel

Alert "evel

Action "evel

2unction

eing

Monitored

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#rend 'egins


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Correct the negati"e trend 4y mani!ulating the !ro!er

CPP

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Action "evel

Alert "evel

Alert "evel

Action "evel

2unction

eing

Monitored

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egin Banipulating

CPP

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;1

P0T C0 */ IT

Process Analyer

Processing step

Product 8ualityK ( *input property, intermediate property, processing conditions, )uantityand )uality o( processing input, etc.-

Computer Bodel

3esult o( analysis

or reading

Critical

Sample?3eading

Product o( accepta'le

)uality

Processing step

Control signal

Banipulate process intodesired state

InputProcessing step

inal stepProduct )uality reading

Process analyer

3esult o( analysis

or reading

In!ut*material, heat,

agitation, etc.-



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%egative event

CAPA


$5am!le Monitoring data


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CAPA

CAPAK Corrective Action Preventive

Action

A process which uses many o( the e:isting)uality system components to ensure

process remains in a state o( control.

Action is ta@en to correct a deviation or noncon(ormance *)uality event-, 'ased on level

o( ris@.

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CAPA

As issues are corrected or prevented (romhappening again you return the process into a

state o( control and improve the process

In cases o( intolera'le ris@ action is ta@en toprevent the reoccurrence o( the )uality event.

Bany o( these actions re)uire changes, which

should 'e implemented a(ter invo@ing the

change control system to insure system

remains in a validated state o( control.

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CAPA

Fse ris@ assessment and your @nowledge o( theprocess to determine the degree o( corrective

and preventive action to 'e ta@en.

#he level o( e((ort, its (ormality and the levelo( documentation should 'e commensurate

with the level o( ris@ and 'e 'ased on science.

Bany o( the actions ta@en correct or prevent a

processing pro'lem re)uire changes to the

operation2Fse Change Control to manage

them.


Change Control System

Change

Identi(iedGBP

IssuesL

&mergencyL

Initiate

Change

Control

Implement as

Baintenance

$'tain

Approvals

Implement

Change

Document

Change

Implement

Compliance

3e)uirements

%$%$

=&S =&S


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Change Control Procedure

Initiate change *simple (orm with

Husti(ication, technical in(ormation and drawings-.

3eview and approval *)uality unit, usergroup, engineering, validation pro(essional,

regulatory a((airs, sa(ety and environmental-. Identi(y GBP implications


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Change Control Procedure

6cont.7

De(ine what is needed to ma@e the

change permanent.

Identi(y revalidation re)uirements, i(

any, and implement.

Change permanent.


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Initiating Change

A short and concise (orm

Should have space (or comments and

approvals Should have all in(ormation needed to

render Hudgment

Should have space to de(ine re)uirements(or implementing change


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Change 3e)uest orm

Page 1

$riginatorMs In(ormation

Date

Short #itle

3eason (or 3e)uesting Change

Description o( 3e)uested Change

nown or Suspected GBP Implications Add support documentation and?or drawings


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Change 3e)uest ormPage

3eview, 3e)uirements, and Approval

#echnical review and comments 'y engineering,

technical services, operation, regulatory, sa(ety,

environmental, and 8A2recommend approval?disapproval 3eview and approval 'y Change Control Committee

*needed i( disagreements occur a'ove-

De(ine re)uirements to 'e satis(ied (or change

implementationN validation, document or drawing

modi(ication, procedure modi(ication, etc.

Ch C t l d


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Change Control procedure

$nd

$nd

Change re-uired

'enerate

Change (e-uest

'MP

Im!lications&

o

o

8es

(e-ualification&

(e"alidation&

8es

Implement Change

Baintenance

Im!lement Change

Insure 'MP

(e-uirements *one

Issue 'MP

(e!ort

/4tain 0!!ro"al

Change is

Permanent

(e-ualify

(e"alidate

Issue (e!orts

/4tain

0!!ro"als

Change is

Permanent


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&mergency Changes

Implement Change

ill out paper wor@ and circulate (or comments

and approval *within 05 hours- Implement GBP re)uired actions immediately

3elease is contingent on additional testing and

implementation o( GBP re)uirements.

eep a close eye on the lots released once

distri'uted and (acilitate (ast customer (eed'ac@.


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Post Change Bonitoring and its

Importance

$nce change is implemented and 'ecomespermanent you must continue to monitor thechanged part to ensure a- change achieved its o'Hective and '- that no unintended issues arise.

Do a lot o( monitoring in the 'eginning toesta'lish 'ac@ground in(ormation, then scale 'ac@to a statistically appropriate level.

"oo@ at variation (or the 'atch and also (or 'atchto 'atch variations.

Always 'e )uantitative and use statistical methodswhen ever possi'le.


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Documents

Validation Change Control Maintaining The Validate State-09-2015.pptx