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
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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 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'
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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" 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
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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
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
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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 4
ICH Q9 QUALITY RISK MANAGEMENT
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
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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
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
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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 5
ICH Q9 QUALITY RISK MANAGEMENT
II.3" Q1) as part of development
• 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
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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 6
ICH Q9 QUALITY RISK MANAGEMENT
II.3" Q1) as part of development
• 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
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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 9
ICH Q9 QUALITY RISK MANAGEMENT
+ of C2D as part of a regulatory sumission
In line 0ith Quality 1isk )anagement @
E"AMPLE
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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
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
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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 &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%
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#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$ !""#
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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
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$ !""#
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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
1isk to patient
Unit operations/Quality attributes
Dispensing (RawMaterial Properties)
Granulation DryingBlending
(MagnesiumStearate)
Tableting Pa!aging
Dissolution Partile si"e #P$Power
onsumptionPrior !nowledge
%ot ritial to&uality
%ot ritial to&uality
Prior !nowledge
Disintegration Partile si"e #P$ water amount and
'eed ratePrior !nowledge
%ot ritial to&uality
%ot ritial to&uality
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 %$R measurement Prior !nowledge
Content uniformity Prior !nowledgePower
onsumption%ot ritial to&uality
%ot ritial to&uality
%$R measurement Prior !nowledge
Degradation Prior !nowledgeater amount and'eed rate
%ot ritial to&uality
Prior !nowledge Prior !nowledge Prior !nowledge
Stability Prior !nowledge Prior !nowledgeontrol waterontent
Prior !nowledge Prior !nowledge Prior !nowledge
Appearance Prior !nowledge Prior !nowledge
%ot ritial to
&uality Prior !nowledge
%ot ritial to
&uality Prior !nowledge
Identification %$R o' raw material Prior !nowledge Prior !nowledge Prior !nowledge Prior !nowledge Prior !nowledge
Water Prior !nowledge Prior !nowledgeontrol waterontent
Prior !nowledge Prior !nowledge Prior !nowledge
MicrobiologySpei'iation o'starting material
Puri'ied waterused
Prior !nowledge Prior !nowledge Prior !nowledge Prior !nowledge
low
Proess understanding
)ontrol Strategy
'nit operation
Q u a l i t y A t t r i u t e s
E"AMPLE
E.7I- 7-& &G$ !""#
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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
1isk 1evie0
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 the
Quality 1isk )anagement +rocess
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
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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 %4
ICH Q9 QUALITY RISK MANAGEMENT
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
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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