In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.

1. QbD/Valida*on
Applica*on
-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐-­‐
COMPLIANCE
BY
DESIGN
(CbD)
QUALITY
SYSTEMS
BY
DESIGN
(QSbD)
and
COMPLIANCE
MASTER
PLAN
(CMP)
QUALITY
SYSTEMS
MASTER
PLAN
(QSMP)
A
LIFECYCLE
Approach
Paul
L.
Pluta,
PhD
1

2. OUTLINE
/
OBJECTIVES
1.
Why?
2.
Quality
by
Design
(QbD)
– Compliance
by
Design
(CbD)
comparison
3.
Valida@on
Master
Plan
(VMP)
– Compliance
Master
Plan
(CMP)
comparison
4.
Lifecycle
Approach
– Compliance
Lifecycle
comparison
5.
Implementa@on
6.
Benefits
and
Problems
7.
Discussion
2

3. WHY
CbD
/
CMP
/
LIFECYCLE
APPROACH?
Development
has
been
revolu@onized
by
QbD
-­‐-­‐
an
organized
approach
with
defined
objec@ves
and
steps.
Industry
and
regulatory
have
strongly
embraced
and
supported
QbD.
Valida@on
Master
Plans
(VMP)
are
successful
and
widely
accepted
documents
useful
to
industry
and
regulatory.
The
FDA
Process
Valida@on
Guidance
has
introduced
the
lifecycle
approach
to
process
valida@on.
Coincident
with
growth
and
success
of
QbD
have
been
serious
GMP
compliance
incidents
(heparin,
glycerin,
Viracept,
J&J,
Genzyme).
Can
QbD,
VMP,
and
lifecycle
approaches
be
applied
to
improve
compliance?
3

4. CbD
/
CMP
/
LIFECYCLE
OVERVIEW
QUALITY
SYSTEMS
Development
of
system
– Objec@ve
and
aYributes
of
quality
systems
– Parameters
to
achieve
objec@ves
and
aYributes
– Varia@on
affec@ng
parameters
– Control
of
varia@on
Performance
of
system
– Quality
system
performance
process
Maintaining
system
– Maintain
and
monitor
quality
system
– Improvement
projects
Documenta@on
4

5. QUALITY
BY
DESIGN
• Target
product
profile
(TPP)
and
cri@cal
quality
aYributes
(CQA)
• Drug
substance
and
excipient
proper@es
• Formula@on
design
and
development
• Manufacturing
process
design
and
development
• Iden@fica@on
of
cri@cal
process
parameters
(CPP)
and
cri@cal
material
aYributes
(CMA)
• Risk
assessment
and
design
space
• Scale
up,
iden@fica@on
of
variables,
and
control
strategy
Red
=
Original
QbD
5

6. COMPLIANCE
by
DESIGN
CbD
is
an
organized
approach
to
compliance
with
quality
systems.
CbD
has
a
defined
structure
with
objec@ves
and
associated
content.
CbD
con@nues
throughout
the
lifecycle
of
the
quality
systems.
CbD
approaches
quality
systems
as
a
development
project
in
the
manner
of
QbD.
Can
compliance
be
improved
by
using
QbD
concepts?
6

7. COMPARISON
–
COMPLIANCE
BY
DESIGN
and
QUALITY
BY
DESIGN
Objec@ves
and
cri@cal
compliance
aYributes
(CCA)
– What
are
the
goals
of
each
quality
system?
– What
makes
a
quality
system
successful?
Cri@cal
compliance
parameters
(CCP)
– What
factors
may
significantly
influence
the
success
of
the
quality
system?
Input
varia@on
and
control
– What
varia@on
in
quality
system
opera@on
is
expected
and
how
is
it
controlled?
Ongoing
maintenance
and
management
– How
is
performance
monitored
and
maintained?
Con@nuous
improvement
projects
– How
can
the
quality
system
be
improved?
CbD
approach
equivalent
to
QbD
=
Stage
1
process
valida*on
Ongoing
maintenance
and
management
=
Stage
3
process
valida*on
Con*nuous
improvements
expected
from
ongoing
monitoring.
7

8. VALDIATION
MASTER
PLAN
Sec@ons
discuss
site
valida@on
categories
– Valida@on
policy
– Equipment
– Facili@es
(HVAC)
– U@li@es
– Process
– Cleaning
Tables
with
document
references
(IQ,
OQ,
PQ)
Valida@on
commitments
and
@melines
Regular
updates
(quarterly?)
related
to
needs
frequency
Note
“chapters”
of
VMP
VMP
is
rou*nely
requested
by
regulatory
auditors.
8

9. COMPLIANCE
MASTER
PLAN
CMP
is
an
organized
approach
to
documen@ng
the
CbD
methodology.
CMP
has
a
defined
approach,
structure,
and
content.
CMP
is
a
working
document
that
is
con@nually
maintained
throughout
the
quality
systems
lifecycle.
Can
compliance
documenta*on
be
improved
by
use
of
VMP
concepts?
9

10. COMPLIANCE
MASTER
PLAN
• Quality
System
• Facili@es
and
Equipment
System
• Materials
System
• Produc@on
System
• Packaging
and
Labeling
System
• Laboratory
Control
System
• Training
System
• Valida@on
System
• Product
Review
System
• Stability
System
• Product
Complaint
System
• Others
Red
=
FDA
Quality
Systems
Note
“chapters”
of
CMP
10

11. COMPLIANCE
MASTER
PLAN
SYSTEM
TITLE
• System
and
subsystem
descrip@ons
– Objec@ve
and
cri@cal
aYributes
– Cri@cal
parameters
affec@ng
objec@ve
– Input
variables
and
control
strategy
– Ongoing
maintenance
and
management
• Con@nuous
improvement
project
status
• References
(includes
project
reports)
11

12. LIFECYCLE
APPROACH
FDA
Process
Valida*on
Guidance
(January
2011)
Lifecycle
Approach
to
Process
Valida*on
• Stage
1.
Process
Design
– Includes
QbD,
PAT,
risk
management
• Stage
2.
Process
Qualifica@on
• Stage
3.
Con@nued
Process
Verifica@on
Process
valida@on
always
ongoing
Con@nuous
improvements
expected
12

13. LIFECYCLE
APPROACH
1. Understanding
and
planning
2. Performance
3. Maintenance
and
monitoring
• System
performance
4.
Con@nuous
improvement
Applica*on
to
equipment,
computer
systems,
etc.
13

14. LIFECYCLE
APPROACH
Valida*on
Evolu*on
1978
-­‐-­‐
CGMP
includes
Valida@on
VALIDATION
-­‐-­‐
Control
1987
-­‐-­‐
Development
-­‐-­‐
2008
à
2011
Lifecycle
approach
Con@nuum
of
understanding
–
valida@on
–
maintenance
UNDERSTANDING
à
VALIDATION
à
MAINTENANCE
à
IMPROVEMENT
14

15. LIFECYCLE
APPROACH
Recent
speakers
on
various
aspects
of
valida@on
and
qualifica@on
have
adopted
the
lifecycle
approach
to
their
fields.
– Equipment
– Facili@es
– U@li@es
– Cleaning
– Computer
systems
Can
compliance
be
improved
by
use
of
lifecycle
concepts
of
process
valida*on?
Are
quality
systems
designed,
maintained,
and
monitored
to
yield
con*nuous
system
improvements?
15

16. LIFECYCLE
APPROACH
ICH
Q10.
Pharmaceu*cal
Quality
Systems
• Pharmaceu@cal
Development
• Technology
Transfer
• Manufacturing
• Product
Discon@nua@on
ICH
Q10
primary
focus
-­‐-­‐
product
performance
throughout
product
lifecycle.
CbD
focus
-­‐-­‐
quality
systems
performance
throughout
quality
system
lifecycle.
16

17. IMPLEMENTATION
AND
EXAMPLES
Overview
and
approach
Material
System
• Mul@ple
subsystems
in
process
series
• Equivalent
to
manufacturing
processes
Training
System
• One
system
serves
all
site
areas
• Different
competency
requirements,
i.e.,
different
risk
levels
Valida*on
System
• One
system
serves
all
site
areas
• Different
valida@on
requirements,
i.e.,
manufacturing
process
,
cleaning
process,
equipment,
facili@es,
u@li@es,
etc.
17

18. CbD
/
CMP
/
LIFECYCLE
IMPLEMENTATION
1.
Iden@fy
systems
in
the
organiza@on
– FDA
systems
(6)
are
major
systems
– Addi@on
“subsystems”
are
iden@fied
in
FDA
Quality
System
– Other
systems
support
mul@ple
major
systems
2.
For
an
individual
system:
– Iden@fy
complete
business
process
– Iden@fy
subsec@ons
– Iden@fy
objec@ves
,
CCA,
CCP,
varia@on,
controls
for
all
subsec@ons
– Gap
analysis
of
subsec@ons
– Risk
analysis
of
subsec@ons
3.
Con@nuous
improvement
projects
based
on
gap
analysis,
risk
analysis,
and
ongoing
monitoring
4.
Documenta@on
in
CMP
5.
Repeat
for
all
systems
based
on
risk.
18

19. CbD
/
CMP
LIFECYCLE
IMPLEMENTATION
– Iden@fy
complete
business
process
– Iden@fy
system
subsec@ons
– Iden@fy
objec@ves
and
CCA,
CCP,
varia@on,
and
controls
for
all
subsec@ons
– Gap
analysis
of
subsec@ons
– Risk
analysis
of
subsec@ons
– Ini@ate
improvement
projects
– Documenta@on
Above
analysis
and
evalua*on
conducted
by
management,
each
sec*on
staff,
and
QA
-­‐-­‐
with
cross
func*onal
input
– Staff
par*cipa*on
cri*cal
– Cross-­‐func*onal
input
cri*cal
Ex:
Process
experience,
incoming
test
data,
vendor
audits
Ex:
Process
experience,
devia@ons,
CAPA,
training
19

20. EXAMPLE:
MATERIAL
SYSTEM
BUSINESS
PROCESS
1.
Iden@fy
approved
vendors
to
source
incoming
materials
– Vendors
approved
by
Vendor
QA
2.
Receive
incoming
materials
3.
Store
incoming
materials
–
quaran*ne
status
4.
Submit
samples
for
tes*ng
5.
Receive
and
evaluate
test
results
6.
Transfer
tested
materials
to
materials
to
status
areas
– Approved
or
Rejected.
Materials
on
test
remain
in
quaran*ne
7.
Dispense
approved
materials
to
manufacturing
and
packaging
loca*ons
8.
WFI,
gas,
and
compressed
air
distribu*on
9.
Received
and
store
manufactured
/
finished
products
–
quaran*ne
status
10.
Transfer
tested
materials
to
status
areas
– Approved
or
Rejected.
Materials
on
test
remain
in
quaran@ne
11.
Transfer
approved
materials
to
distribu*on
center
12.
Ship
approved
materials
from
distribu*on
center
to
customer
20

21. COMPLIANCE
BY
DESIGN
MATERIAL
SYSTEM
SUBSECTIONS
Incoming
Materials
-­‐-­‐
Sourcing
Incoming
Materials
–
Storage/tes*ng/disposi*on
Drug
dispensing
Water/gas/air
tes*ng/distribu*on
Finished
Products
–
Storage/tes*ng/disposi*on
Finished
Products
–
Distribu*on
Finished
products
–
Offsite
distribu*on
Above
customized
to
site
organiza*on
21

22. COMPLIANCE
BY
DESIGN
-­‐-­‐
MATERIAL
SYSTEM
INCOMING
MATERIALS
-­‐-­‐
SOURCING
System
objec*ve
and
cri*cal
akributes
• Obtain
high
quality
materials
(API,
excipients,
commodi@es)
from
QA-­‐approved
vendors
for
eventual
dispensing
to
product
manufacturing
Cri*cal
parameters
affec*ng
objec*ve
• QA
audit,
inves@gate,
and
approve
material
suppliers
• Vendor
procedure,
process,
and
management
changes
Input
variables
and
control
strategy
• Material
varia@on
• Vendor
outsource
commodity
items
Ongoing
maintenance
and
management
• Approved
supplier
list
• Material
specifica@ons
• Material
test
data
monitoring
• Non-­‐conforming
materials
received
Con*nuous
improvement
project
status
1.
Risk
analysis
of
incoming
materials.
See
Appendix
for
project
descrip@on.
2.
Supplier
risk
evalua@on.
See
Appendix
for
project
descrip@on.
Reference
documenta*on
• Risk
analysis
of
incoming
materials.
J.
Doe,
1-­‐1-­‐10.
• Supplier
risk
evalua@on.
J.
Smith
1-­‐4-­‐10
Appendix
1.
Project
Descrip@on:
Risk
analysis
of
Incoming
Materials.
2.
Project
Descrip@on:
Supplier
Risk
Evalua@on.
22

23. COMPLIANCE
BY
DESIGN
-­‐-­‐
MATERIAL
SYSTEM
INCOMING
MATERIALS
–
STORAGE
/
TESTING
/
DISPOSITION
System
objec*ve
and
cri*cal
akributes
• Storage
of
high
quality
materials
(API,
excipients,
commodi@es)
prior
to
dispensing
to
product
manufacturing.
Materials
stored
according
to
recommended
temperature.
Materials
stored
according
to
QA
disposi@on
(Approved,
Quaran@ne,
Rejected)
Cri*cal
parameters
affec*ng
objec*ve
• Vendor
storage
recommenda@ons
• Vendor
expira@on
date
recommenda@ons
• Power
supply
to
storage
areas
Input
variables
and
control
strategy
• Storage
recommenda@ons
per
vendor
checklist.
• Expira@on
date
recommenda@ons
per
vendor
checklist.
• Alarm
system
for
temperature
limits
Ongoing
maintenance
and
management
• Material
inventory
list
ongoing
• Facility
monitoring
system
Con*nuous
improvement
project
status
• Refrigera@on
backup
generator
Reference
documenta*on
• Material
requirements
23

24. EXAMPLE:
TRAINING
SYSTEM
BUSINESS
PROCESS
Func*ons,
work
centers,
procedures
(training
modules),
and
personnel
Training
system
uses
validated
tracking
sokware
Training
system
defines
training
categories
Func@on
defines
work
centers
Func@on
assigns
procedures
to
work
centers
-­‐
Procedures
include
training
category
and
retraining
frequency
(risk
based)
-­‐
Training
modules
wriYen
-­‐
Training
modules
approved
Func@on
assigns
personnel
to
work
centers
Func@ons,
work
centers,
procedures,
and
personnel
entered
into
tracking
sokware
QA
approval
1.
Personnel
trained
according
to
category
and
frequency
2.
Personnel
training
comple@on
in
tracking
system
3.
Training
status
reported
by
sokware
4.
Training
modules
evaluated
by
trainees
24

25. TRAINING
CATEGORIES
Company
informa@on
(general
news,
holidays)
Awareness
of
common
procedures
(ethics,
analy@cal
methods,
tablet
machine
parameters)
–
read
and
sign
Policies
and
procedures
–
(GMP)
-­‐-­‐
classroom
Performance
(OtJ)
training
(HPLC,
tablet
machine
opera@on)
qualifica@on
SME
qualifica@on
(expert
designa@on)
External
con@nuing
educa@on
(scien@fic
mee@ngs)
25

26. COMPLIANCE
BY
DESIGN
–
TRAINING
SYSTEM
System
objec*ve
and
cri*cal
akributes
• Provide
effec@ve
training
to
site
personnel
Cri*cal
parameters
affec*ng
objec*ve
• Development
of
high
quality
training
modules
• Selec@on
of
appropriate
training
category
and
retraining
frequency
• Competency
of
training
instructors
Input
variables
and
control
strategy
• Employee
experience
and
learning
mo@va@on
• Work
center
recommenda@ons
on
training
category
and
retraining
frequency
Ongoing
maintenance
and
management
• Training
module
comple@on
records
• Trainee
evalua@ons
• Correla@on
of
training
modules
and
excep@on
events
Con*nuous
improvement
project
status
1. Risk
analysis
of
site
posi@ons.
See
Appendix
2. Training
Module
X
development
Reference
documenta*on
• Risk
analysis
of
site
posi@ons.
J.
Jones,
1-­‐1-­‐10.
Appendix
Project
Descrip@on:
Risk
Analysis
of
Site
Posi@ons
26

27. EXAMPLE:
VALIDATION
SYSTEM
BUSINESS
PROCESS
1. Site functions design / develop new systems or changes
2. Site functions initiate new validations and qualifications or changes to validated
systems.
• New product / processes
• New equipment, facilities, utilities
• Other
Sources of validation / qualification activities
• R&D, Technical Support
• Operations
• Quality Assurance / Quality Control
• Maintenance
3. Validation process /documentation written/monitored by validation group
• Different requirements for different validation / qualification
• Risk analysis
4. Appropriate post-validation tracking responsibility of QA
• Product process data (APR)
• Non-conformances and deviations; complaints, changes, others
• Management review
27

28. VALIDATION
CATEGORIES
Process
valida@ons
• Manufacturing
• Cleaning
• Packaging
• Analy@cal
• Others
Qualifica@ons
–
IQ,
OQ,
PQ;
ASTM
E2500
• Equipment
• Facili@es
• U@li@es
• Computer
systems
• Others
28

29. COMPLIANCE
BY
DESIGN
–
VALIDATION
SYSTEM
System
objec*ve
and
cri*cal
akributes
• Provide
effec@ve
lifecycle
valida@on
services
to
site
Cri*cal
parameters
affec*ng
objec*ve
• Development
of
high
quality
products/processes,
equipment,
other
systems.
• Documenta@on
of
development
process
and
ac@vi@es
and
retrieval
of
documents
• High
quality
valida@on
documenta@on
• Post-­‐valida@on
monitoring
program
with
periodic
management
review
Input
variables
and
control
strategy
• Technical
exper@se
• Knowledge
or
valida@on
requirements
and
expecta@ons
• Employee
training,
experience,
and
mo@va@on
Ongoing
maintenance
and
management
• Iden@fica@on
of
appropriate
post-­‐valida@on
monitoring
• Management
review
program
• Change
control
awareness;
Change
control
program
within
related
areas
Con*nuous
improvement
project
status
• Iden@fica@on
of
improvement
projects,
e.g.,
valida@on
training
Reference
documenta*on
• Valida@on
documenta@on
Appendix
• Project
reports
29

30.
COMPLIANCE
MASTER
PLAN
• Introduc@on
and
policy
• Quality
System
• Facili@es
and
Equipment
System
• Materials
System
• Produc@on
System
• Packaging
and
Labeling
System
• Laboratory
Control
System
• Training
System
• Valida@on
System
• Product
Review
System
• Stability
System
• Product
Complaint
System
• Others
Each
system
with
subsec*ons
has
descrip*on,
objec*ves,
CQA,
CCP,
varia*on,
control
of
varia*on,
projects
completed
(improvements),
commitments,
etc.
CMP
available
to
auditors
30

31. CbD
/
CMP
/
LIFECYCLE
POSITIVES
• Organized
and
comprehensive
focus
on
compliance
based
on
risk
to
the
pa@ent
and
the
organiza@on
–
Based
on
successful
concepts
• System
design
-­‐-­‐
Gap
analysis
• Risk
analysis
• Cross-­‐func@onal
systems
thinking
• Consistent
priori@zed
mi@ga@on
ac@vi@es
across
func@ons
–
based
on
risk
• Varia@on
iden@fica@on
and
control
strategy
• Centralized
tracking
of
commitments
• Con@nuous
improvements
based
on
systems
monitoring
• Standardized
audit
expecta@ons
and
documenta@on
• Organiza@on
commitment,
transparency,
and
credibility
• Track
organiza@on
accomplishments
completed
• Strong
message
to
employees
• Strong
message
to
auditors
• Poten@al
“credit”
in
audits
for
projects
completed
and
new
commitments
iden@fied
31

32. CPD
/
CMP
/
LIFECYCLE
NEGATIVES
Difficult
• Gepng
organized
is
extremely
difficult!
• Risk
analysis
is
difficult
• Gap
analysis
is
difficult
• Changes
are
difficult
Transparency
• Being
open
about
gaps
and
deficiencies
may
have
regulatory
and
poli@cal
risks
Organiza*onal
commitments
• Headcount
needed
to
correct
deficiencies
Do
the
benefits
outweigh
the
nega*ves?
32

33. OTHER
THOUGHTS
ASTM
E2500
• Addresses
valida@on
cri@cism
by
risk
priori@za@on
• Pfizer
using
FDA
Comments
• Prosecu@on
of
responsible
execu@ves
/
management
• Transparency
• Generally
posi@ve
comments
on
QbD
-­‐-­‐
Concerns
about
implementa@on
• Site
organiza@on
according
to
systems
ICH
Q10
Pharmaceu*cal
Quality
System
Elements
• Process
performance
and
product
quality
monitoring
system
• CAPA
system
• Change
management
system
• Management
review
of
process
performance
and
product
quality
Medical
Devices
• Management
controls
• Design
controls
• CAPA
• Produc@on
and
process
controls
• Steriliza@on
process
controls
• Sampling
plans
instruc@ons
33

34. REGULATORY
COMMENTS
US
and
Interna@onal
Regulatory
• Generally
very
posi@ve
• No
nega@ve
comments
• “I’d
be
blown
away
if
a
company
did
this!”
• “Wow”
• Other
comments
awaited
34

35. GETTING
STARTED
1. Iden@fy
high
risk
areas
– Example:
Sourcing
of
incoming
materials
– Example:
Asep@c
core
area
training
2. Senior
management
discussion
–
risks
to
opera@on
3. Func@on
management
discussion
–
risks
to
opera@on
4. Iden@fy
recep@ve
individuals
in
high
risk
area
5. Training
of
appropriate
individuals
6. Start
slowly
7. Communica@on.
Modify
strategy
as
needed
to
insure
success
8. Expand
effort
based
on
success
9. Expect
resistance
35

36. COMPLIANCE
BY
DESIGN
AND
COMPLIANCE
MASTER
PLAN
LIFECYCLE
APPROACH
-­‐-­‐
SUMMARY
• CbD
based
on
QbD,
CMP
based
on
VMP
• Lifecycle
approach
based
on
lifecycle
approach
to
process
valida@on
– Design,
Perform,
Monitor
• Iden@fy
quality
systems:
FDA,
Quality
Systems,
support
systems
• Iden@fy
business
process
of
systems
à
system
subsec@ons
• Iden@fy
objec@ves
and
CCA,
CCP,
varia@on,
controls,
gaps,
and
risks
• Con@nuous
improvement
projects
based
on
gap,
risks,
monitoring
• Documenta@on
in
CMP
• Posi@ves:
Organized
and
comprehensive
focus
based
on
risk
to
the
pa@ent
and
the
organiza@on,
strong
message
to
employees
and
to
auditors,
“credit”
in
audits
• Nega@ves:
Difficult,
transparent,
deficiencies
iden@fied
• Consistent
with
FDA
direc@on
(Process
Valida@on,
risk),
ASTM
E2500,
and
ICH
Q8,
Q9,
Q10
• Cost
effec@ve
-­‐-­‐
High
risk
ac@vi@es
emphasized
and
priori@zed
• Implementa@on
approach
36

37. INTERACTIVE
DISCUSSION
Comments
on
CbD
Comments
on
CMP
Comments
on
Lifecycle
Terminology:
Compliance
by
Design
(CbD)
and
Compliance
Master
Plan
(CMP)
or
Quality
Systems
by
Design
(QSbD)
and
Quality
Systems
Master
Plan
37

38. REFERENCES
Pluta,
Paul
L.
and
Richard
Poska.
“Compliance
by
Deisgn
(CbD)
and
Compliance
Master
Plan
(CMP).
An
Organized
Approach
to
Compliance.” J.
GXP
Compliance,
V
14,
#2,
Spring
2010.
Pluta,
Paul
L.,
Richard
Poska,
and
Timothy
J.
Fields.
“Compliance
by
Design
and
Compliance
Master
Plan” Pharmaceu4cal
Technology,
V35,
#3,
March
2011.
Nash,
Robert
A.
“The
Concept
of
Establishing
a
Compliance
Master
Plan
(CMP).” J.
Valida4on
Technology,
V
12,
#2,
February
2006.
Borkar,
M.M.,
A.A.
Shirwaikar,
and
P.G.
Shilotri.
“Step
by
Step
Approach
to
Quality
System
Implementa@on
and
Regulatory
Compliance.” J.
GXP
Compliance,
V
9,
#2,
January
2005.
Yu,
Lawrence
X.,
et.
al.,
“Quality
by
Design
for
Generic
Drugs.”
PharmTech.com,
October
2,
2009.
38

39. COMMERCIAL
Book
chapter
authors
Pilot
program
• System
or
subsec@on
using
CbD
approach
Writers
for
JVT
and
JGXP
• Sample
journals
• Brochure
with
example
papers
• New
features
and
ongoing
features
39

40. PAUL
L.
PLUTA,
PhD
Editor-­‐in-­‐Chief
• Journal
of
Valida4on
Technology
• Journal
of
GXP
Compliance
Adjunct
Associate
Professor
• University
of
Illinois
at
Chicago
(UIC)
College
of
Pharmacy,
Chicago,
IL,
USA
Editor
and
Chapter
Author
• Cleaning
and
Cleaning
Valida4on,
Volume
1.
Basics,
Expecta4ons,
and
Principles.
PDA
and
Davis
Healthcare
Interna@onal
(DHI)
Publishing,
2009
• Cleaning
and
Cleaning
Valida4on,
Volume
2
.
Applica4ons
of
Basics
and
Principles.
PDA
and
Davis
Healthcare
Interna@onal
(DHI)
Publishing,
2012
(expected)
Contact:
paul.pluta@comcast.net
40