3 Quality Risk Management as Part Of

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Annex II: Potential Applications

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide %

ICH Q9 QUALITY RISK MANAGEMENT

II. 3 Quality risk management as part of…

DevelopmentCompetent

Authorities

Industry

See also next chapters

using the intention to e applicale for developmentII.!" #acilities$ %&uipment and 'tilities

II.(" )aterials )anagement

II.*" +roduction

II.," -aoratory Control and Staility Studies

II." +ackaging and -aelling /ote" +rocess understanding and criticality may e applied only to ne0 products




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide !

ICH Q9 QUALITY RISK MANAGEMENT CNSI!ERATINS

Aout development

All parameters anddimensions that defne a

product

Parameters that impactcustomer requirements

CriticalParameters

that contributeto variation in customer

requirements

&' (atsumura$ Eisai Co'




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide )


II.3" Q1) as part of development

• 2o design a &uality product and its manufacturing process

* to consistently deliver the intended performance

of the product see IC4 Q5

• 2o enhance kno0ledge of product performance

over a 0ide range of

* material attriutese.g. particle si6e distriution$ moisture content$ flo0 properties5

* processing options

* process parameters

ICH Q9




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide +


Quality y design" 7Special Cause8 or 7Common Cause8

• Conse&uence" #re&uent$ ma9or ::S

• Corrective actions eliminate 7Special Cause8

1esult" 'nstale process

;alidation

+roduction

,ased on -' Hussain$ .-$ 0eptember !""+

E"AMPLE

Note: 1on detected 2o0could result in a patient ris3




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide 4


Quality y design " 7Special Cause8 or 7Common Cause8

• 1educe 7Common Cause8 ;ariaility

• Conse&uence" :n the continuous improvement path

1esult" Stale < Capale

;alidation

+roduction

-' Hussain$ .-$ 0eptember !""+

E"AMPLE




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide #


Quality y design " 7Special Cause8 or 7Common Cause8

• Conse&uence" )inor$ occasional :oS

• 1educe 7Common Cause8 ;ariaility

1esult" Stale= >es? Capale@

;alidation

+roduction

-' Hussain$ .-$ 0eptember !""+

E"AMPLE







• 2o assess the critical attriutes of

* 1a0 materials

* Solvents

* Active +harmaceutical Ingredient A+I5

* Starting materials

* %xcipients

* +ackaging materials

• 2o estalish appropriate specifications$ identify critical

process parameters and estalish manufacturing controls

ICH Q9







• 2o decrease variaility of &uality attriutes"

* reduce product and material defects

* reduce manufacturing defects

• 2o assess the need for additional studies

e.g.$ ioe&uivalence$ staility5

relating to scale up and technology transfer

• 2o make use of the 7design space8 conceptsee IC4 Q5

ICH Q9






+ of C2D as part of a regulatory sumission

In line 0ith Quality 1isk )anagement @

E"AMPLE




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide %"


1isk 1evie0

1 i s k C o m m u n i c a t i o n

1isk Assessment

1isk %valuation

unacceptale

1isk Control

1isk Analysis

1isk 1eduction

1isk Identification

1evie0 %vents

1isk Acceptance

Initiate

Quality 1isk )anagement +rocess

:utput B 1esult of theQuality 1isk )anagement +rocess

1isk)anagementtools

+ of C2D as Quality 1isk )anagement process @

+rocess understanding

#ormulation < +rocess design

+rocess control Concept

+roduct release Concept

1evie0 the sumission

1egulatory strategy

)anufacturing Concept

E"AMPLE




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide %%

ICH Q9 QUALITY RISK MANAGEMENT &arget 7roduct 7rofile

rug substance properties; prior 3no8ledge

7roposed formulation and manufacturing process

etermination of

Cause Effect relationships:is3 Identification 8ith subse<uent is3 -nalysis=

is3>based classification:is3 E?aluation=

7arameters to in?estigate :e'g' by 2E=:is3 eduction %' proposal; !' ?erified=

#:1)'-A2I:/#:1)'-A2I:/D%SI/ S+AC%D%SI/ S+AC%

+1:C%SS+1:C%SSD%SI/ S+AC%D%SI/ S+AC%

> '/I2 :+%1A2I:/> '/I2 :+%1A2I:/C:/21:-C:/21:-

S21A2%>S21A2%>

#ormul a

tionunderst a

nd

ing

#ormula

tionu

nderstanding

+ r o c e s s u n d e r s

t a n d i n g

+ r o c e s s u n d e r s

t a n d i n g

1e=evaluation

andconfirma

tion

1e=eva

luationandco

nfirma

tion

1 e = e v a l u a t i o n a n d c

o n f i r m a t i o n

1 e = e v a l u a t i o n a n d c

o n f i r m a t i o n

+roduct and process

characteristics on the

final drug product

1evie0 events

Development

Developm.

:peration

1esearch

+hase E

+hase

+hase 3

-aunch

E"AMPLE

E.7I- 7-& &G$ !""#




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide %!


1isk )anagement approach to focus on critical attriutes

Q

u a l i t y A t t r i u t e s

'nit operation

Granulation rying ,lending &abletingispensing

issolution

isintegration

Hardness

-ssayContent

@niformity

egradation

0tability

-ppearance

Identification

Water

(icrobiology

Control

Strategy

#ormulation

and +rocess

understanding

+riorkno0ledge

Significant

influence

Initial

assessment

#irst < Second

revie0 cycle

2hirdrevie0 cycle

E"AMPLE

E.7I- 7-& &G$ !""#




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide %)


1isk to patient

Unit operations/Quality attributes

Dispensing (RawMaterial Properties)

Granulation DryingBlending

(MagnesiumStearate)

Tableting Pa!aging

Dissolution Partile si"e #P$Power

onsumptionPrior !nowledge

%ot ritial to&uality


Prior !nowledge

Disintegration Partile si"e #P$ water amount and

'eed ratePrior !nowledge



Prior !nowledge

Hardness Prior !nowledge Prior !nowledge Prior !nowledge%ot ritial to

&uality

%ot ritial to

&uality

Prior !nowledge

Assay Prior !nowledge Prior !nowledge Prior !nowledge Prior !nowledge %$R measurement Prior !nowledge

Content uniformity Prior !nowledgePower

onsumption%ot ritial to&uality


%$R measurement Prior !nowledge

Degradation Prior !nowledgeater amount and'eed rate


Prior !nowledge Prior !nowledge Prior !nowledge

Stability Prior !nowledge Prior !nowledgeontrol waterontent


Appearance Prior !nowledge Prior !nowledge

%ot ritial to

&uality Prior !nowledge

%ot ritial to

&uality Prior !nowledge

Identification %$R o' raw material Prior !nowledge Prior !nowledge Prior !nowledge Prior !nowledge Prior !nowledge

Water Prior !nowledge Prior !nowledgeontrol waterontent


MicrobiologySpei'iation o'starting material

Puri'ied waterused

Prior !nowledge Prior !nowledge Prior !nowledge Prior !nowledge

low

Proess understanding

)ontrol Strategy

'nit operation

Q u a l i t y A t t r i u t e s

E"AMPLE

E.7I- 7-& &G$ !""#




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide %+


1isk 1evie0

1isk Assessment

1isk %valuation

unacceptale

1isk Control

1isk Analysis

1isk 1eduction

1isk Identification

1evie0 %vents

1isk Acceptance

Initiate


:utput B 1esult of the


1isk)anagementtools 1

i s k C o m m u n i c a t i o n

2 e a m f o c u s e d

I n t e r n a l c o n s u l t a t i o n

S t a k e h o l d e r i n v o l v e m e n

t

1esponsiilities in regulatory operations

Industry

A5 1evie0ers

E"AMPLE

5 Inspectorates




prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance uly !""#$ slide %4


Q1) as part of development

provide risk=ased kno0ledge to manufacturer +ast #uture

+arameters and range Fe have additional dimensions

• :pen &uestion"

4o0 to challenge information for sumission@

Ans0er the &uestions in IC4 QG Chapter !"

* Fhat might go 0rong@

* Fhat is the likelihood proaility5

it 0ill go 0rong@

* Fhat are the conse&uences severity5@

E"AMPLE



RawMaterials

Blending Tabletting Packaging

Conventional approach: Testing ater each step to

minimi!e the risk prior to the ne"t step

RawMaterials

Blending Tabletting Packaging

PAT: Continuous or more requent testing and control duringeach step to minimi!e#control the risk prior to the ne"t step

PAT: Process Anal$tical Technolog$

%alidation

&evelopment and Manuacturing

&a3ayoshi (atsumura$ Eisai

E"AMPLE

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