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MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
CONTINUOUS QUALITY VERIFICATION
(CQV)
G.K.Raju, Ph.D.Pharmaceutical Manufacturing Initiative (PHARMI),
MIT Program on the Pharmaceutical Industry,Massachusetts Institute of Technology
July 2001
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Objective: To Describe the Opportunity to Improve
Pharmaceutical Manufacturing Performance
MIT Pharmaceutical Manufacturing Initiative
Research Development Manufacturing Marketing
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Pharmaceutical Manufacturing
Research Development Manufacturing Marketing
BulkActive
BulkFormulation
Filling &Finish
PackagingInboundLogistics
OutboundLogistics
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
HORIZONTAL APPROACH
STUDYING PHARMACEUTICAL MFG:VERTICAL VS. HORIZONTAL APPROACH
BulkActive
BulkFormulation
Filling/Tableting
Packaging/Finishing
BulkActive
BulkFormulation
Filling/Tableting
Packaging/Finishing
Plant A
BulkActive
BulkFormulation
Filling/Tableting
Packaging/Finishing
BulkActive
BulkFormulation
Filling/Tableting
Packaging/Finishing
Plant B
Plant A
Plant B
VERTICAL APPROACH
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
BulkActive
BulkFormulation
Filling/Tableting/ etc.
Packaging/Finishing
BulkActive
BulkFormulation
Filling/Tableting/ etc.
Packaging/Finishing
Company A
Company B
Company CBulkActive
BulkFormulation
Filling/Tableting/ etc.
Packaging/Finishing
THE HORIZONTAL APPROACH
PHARMACEUTICAL MANUFACTURING
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
DESCRIBING THE OPPORTUNITYIN
ROUTINE MANUFACTURING
CONTINUOUS QUALITY VERIFICATION (CQV)
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
WHICH PROCESSES?
PROCESS CYCLE TIMES
In Process Development
In Routine Manufacturing
Biggest Impact Here?Time-to-marketEnablingPotent Products
Place for Validation?Potent ProductsDifficult ProcessesHigh Volume ProductsProducts with Tough QC TestsGeneric Competition
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS A WITH QC TESTS
WEIGHING WETGRANULATION
STEP FB DRY
STEP
BLEND
ENCAPSULATESIEVE
• API• MICRO
• Particle Size • Description• ID• Assay• CU• Impurity• Dissolution• MICRO
QC1 QC3 QC4
DRY MIX
QC2
• LOD
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS A WITH CYCLE TIMES
WEIGH WETGRANULN
ProcessingFB DRY
STEP
BLEND
ENCAPSULATESIEVE
• API• MICRO
• Particle Size
• Description• ID• Assay• CU• Impurity• Dissolution• MICRO
QC1
QC3
QC4
DRY MIX
QC2
• LOD
7 DAYS 13 DAYS
< 3 DAYS
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS B WITH QC TESTS
CHEMICAL WEIGHING
BLEND FILL CAPSULES BOTTLEPACKAGING
• API• OVI
• Description• ID• Assay• CU• Impurity• Dissolution
QC1 QC2
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS B WITH CYCLE TIMES
CHEMICAL WEIGHING
BLEND FILL CAPSULES
BOTTLEPACKAGING
• API• OVI
• Description• ID• Assay• CU• Impurity• Dissolution
QC1 QC2
7 DAYS14 DAYS
17 DAYS
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS C WITH QC TESTS
WEIGHING
GRANULATION
FB DRY
STEP
BLEND
FILMCOATING
COMPRESS BOTTLEPACKAGING
• API • Particle Size• LOD
• Description• ID• Assay• CU• Impurity• Dissolution
QC1 QC2 QC2
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS C WITH CYCLE TIMES
WEIGHING
GRANULATION
FB DRY
STEP
BLEND FILMCOATING
COMPRESS BOTTLEPACKAGING
• API • Description• ID• Assay• CU• Impurity• Dissolution
QC1 QC2
21 DAYS
6 DAYS 14 DAYS
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS D WITH QC TESTS
CHEMICAL WEIGHING
GRANULATION
Processing
STEP
BLEND 1: BLEND 2: PRE- BLEND
FINALBLEND
FILMCOATING
COMPRESS BOTTLEPACKAGING
• API • Particle Size• LOD
• Description• ID• Assay• CU• Impurity• Dissolution
QC1 QC2 QC3
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS D WITH CYCLE TIMES
QC1
BLEND 2: PRE-BLEND
CHEMICAL WEIGHING
GRANULATION
PROCESSING
STEP
BLEND 1: FINALBLEND
COMPRESS
FILMCOATING
BOTTLEPACKAGING
QC2 QC3
15 DAYS10 DAYS
20 DAYS 15 DAYS
60 DAYS
• Description• ID• Assay• CU• Impurity• Dissolution
• Particle Size• LOD
• API
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS D WITH QC TESTS:Cycle Times including BULK ACTIVE
QC1
BLEND 2: PRE-BLEND
CHEMICAL WEIGHING
GRANULATIONSTEP
BLEND 1:FINALBLEND
COMPRESS
FILMCOATING
BOTTLEPACKAGING
QC2QC3
15 DAYS10 DAYS
20 DAYS 15 DAYS
60 DAYS 21-90 DAYS
PROCESSING
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS D WITH QC TESTSCycle Times
QC1
BLEND 2: PRE-BLEND
CHEMICAL WEIGHING
GRANULATION
PROCESSING
STEP
BLEND 1: FINALBLEND
COMPRESS
FILMCOATING
BOTTLEPACKAGING
QC2QC3
15 DAYS10 DAYS
20 DAYS 15 DAYS
60 DAYS
0
5
10
15
20
QC1 PFD QC3 Release
Actual
Target
Potential
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
WHAT DRIVES THE QC TESTING TIMES?
0
5
10
15
20
QC1 PFD QC3 Release
Actual
Target
Potential
• Sampling• Batching• Other Products• Waiting• Coordinating
• Other Products• Other Paperwork• Waiting• Coordinating
2%
TEST
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
WHICH PROCESSES?
PROCESS CYCLE TIMES
In Process Development
In Routine Manufacturing
Biggest Impact Here?Time-to-marketEnablingPotent Products
Place for Validation?Potent ProductsDifficult ProcessesHigh Volume ProductsProducts with Tough QC TestsGeneric Competition
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS E WITH QC TEST POINTS
WEIGH DRY MIX WET GRANULN
WET GRANULN FL BED DRY MILL
MILL
STOREDRY SIFT WET GRAN MIX MIX
COAT
STORE
MILL
SIFT
STORE
BLEND BLEND BLEND BLEND STORE BOTTLE FILL
DRY
MIX MIX GRANUL DRY MILL
MILL
ACTIVE INITIAL GRANULATION STAGE
SECOND GRANULATION STAGE COATING STAGE
EXCEPIENT PREPARATION STAGE
SIFT&BLEND STAGE BLEND&FILL STAGE
QC4QC3QC2
QC1
LOD
LOD LOD
LOD
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS E WITH QC TEST TIMES
ACTIVE
FIRST GRAN
SECOND GRAN
QC1
7 days
COAT SIFT&BLEND
BLEND
QC4QC3QC2
FILL
7 days7 days3 days
< 1 day
< 1 day
1-2 days
< 1 day
< 1 day
< 1 day
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
WHICH PROCESSES?
TOWARDS PARAMETRIC RELEASE
In Process Development
In Routine Manufacturing
Biggest Impact Here?Time-to-marketEnablingPotent Products
Place for Validation?Potent ProductsDifficult ProcessesHigh Volume ProductsProducts with Tough QC TestsGeneric Competition
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS F: LIQUID LINE
WEIGH
pH ADJ COMPOUND
FILTER
FILL STOPPER CAP
LABEL/PKG
TERMINALSTERILIZATION
WEIGH
WEIGH
VIALS
STOPPERSWFI
BUFFER
WASH
WASH AUTOCLAVE
DEPYROGEN
SEALS
• Appearance• ID• Assay • Impurity• Fill Vol, Osmolarity, Partic.• Endotoxin• STERILITY TESTING
• ENVIRO. MONITORING
• BIOBURDEN
• WFI TESTING• Endotoxin• TOC
• ID
• ID
• pH • Visual Check• Wt Check
• QC Check
• QC Check• QC Check
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS F: LIQUID LINE WITH CYCLE TIMES
10 days
7 days• ENVIRONMENTAL MONITORING
• BIOBURDEN TESTING
17-20 days
7 days
3-4 days
• STERILITY TESTING
• WFI TESTING
3-4 months
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PERCEIVED PROCESS CYCLE TIMES:SUMMARY
Process Process MICRO Optimized Process QC QC:ProcessFlow Type Test? Process? Cycle Time Cycle Time Time
A High Vol. Y Y 3 20 6.7B High Vol. N N 17 21 1.2C High Vol. N N 21 20 1.0D High Vol. N N 20 25 1.3E Variable N Y 7 24 3.4F Parentals Y N 3 20 6.7
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
CYCLE TIME COMPONENTS
STEPS IN THE PROCESS/PLANT IN QC/QAProcess/Unit operation
Interruption of the process
Securing of sample from process
Holding of sample in plant
Documentation and verification of sampling
Transferring of samples to QC lab
Batching of samples in QC
Preparation of test samples
Actual test - separation
Actual test - measurement
Test data collection and processing
Documentation and verification of testing
Transferring of results for review
Decision regarding impact on process
Process/Process Step Primarily Manual OperationInventory Hold Actual test
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
ON-LINE TECHNOLOGY IMPACTSDOMINANT CYCLE TIMES
STEPS IN THE PROCESS/PLANT IN QC/QA
Process/Unit operation
Interruption of the process
Securing of sample from process
Holding of sample in plant
Documentation and verification of sampling
Transferring of samples to QC lab
Batching of samples in QC
Preparation of test samples
Actual test - separation
Actual test - measurement
Test data collection and processing
Documentation and verification of testing
Transferring of results for review
Decision regarding impact on process
Process/Process Step Primarily Manual OperationInventory Hold Actual test
On-line LIF, NIR, Pattern Recognition, etc.
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
CQV OPPORTUNITY IN ROUTINE MANUFACTURING
• Quality Monitoring is Discontinuous• QC testing times are approximately = 1 month• Factor of 20-25 opportunity in cycle time: Process• Factor of 20-25 opportunity in cycle time: QC• QC Cycle Times >= Process Cycle Times• Time is driven by off-line nature of test• Exception is MICRO test
SUMMARY
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
DESCRIBING THE OPPORTUNITYIN PROCESS DEVELOPMENT
CONTINUOUS QUALITY VERIFICATION (CQV)
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
BulkActive
BulkFormulation
Filling &Finish Packaging
BulkActive
BulkFormulation
Filling &Finish Packaging
BulkActive
BulkFormulation
Filling &Finish Packaging
Company A
Company B
Company C
THE VERTICAL APPROACH
BlendingDryingGranulation
Fermentation Rapid MicrobialDetection
FlowTabletingTransport
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
BulkActive
BulkFormulation
Filling &Finish Packaging
BulkActive
BulkFormulation
Filling &Finish Packaging
BulkActive
BulkFormulation
Filling &Finish Packaging
Company A
Company B
Company C
VERTICAL ANALYSIS I:BLENDING UNIT OPERATION
Eg. Blending
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
WHICH PROCESSES?
PROCESS CYCLE TIMES
In Process Development
In Routine Manufacturing
Biggest Impact Here?Time-to-marketEnablingPotent Products
Place for Validation?Potent ProductsDifficult ProcessesHigh Volume ProductsProducts with Tough QC TestsGeneric Competition
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
FOCUS
Explore the Potential Impact of On-line Monitoring Technology on Blending
Process Development
MIT Pharmaceutical Manufacturing Initiative
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Blending Operation Model
Blender cleaning
8
Mixing
Active ingredient
Excipients
Raw material load8 8
Sampling
Transporting
Homogeneity test
OK?
Results & Decision Making
Undermixedmix-longer
Homogeneous
Next batch
Discarded
Next batch
Analysis
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
LIGHT INDUCED FLUORESCENCE SYSTEMFOR THE DETERMINATION OF THE
HOMOGENEITY OF DRY POWDER BLENDING
0
500
1000
1500
2000
2500
3000
3500
4000
4500
0 10 20 30 40 50
Number of Rotations
LIF
Sig
na
l Un
its
A: 5% T/L
B: 5% T/L
C: 5% T/L
PHARMACEUTICAL MANUFACTURING:LIF FOR ON-LINE MONITORING OF BLENDING
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
LIF VERIFICATION STUDIES
Established a correlation between LIF assessment of homogeneity and thief-sampling with off-line analysis
0
1
2
3
4
5
6
4.75% 3.22% 1.64%
Run Batch
En
d P
oin
t D
ete
rmin
ati
on
LIF % Triamterene A
LIF % Triamterene B
Thief Assay A
Thief Assay B
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS D: BLENDING PROCESS DEVELOPMENT
CHEMICAL WEIGHING
GRANULATION
Processing
STEP
BLEND 1: BLEND 2: PRE- BLEND
FINALBLEND
FILMCOATING
COMPRESS BOTTLEPACKAGING
Mixing Of 1:10 Triamterene-Lactose @ 70% Fill & 27.4 RPM
05
10152025303540
0 50 100 150 200 250 300
Number of RotationsP
MT
Sig
nal
s, V
olt
s
• OFF LINE QC TEST
• ON LINE SENSOR
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Raw Materials Sampling Transport Analysis
Results &Decision making
Reprocessed Discarded Well Blended
Information Flow
Materials FlowR/D/W
Process knowledge
Waiting Stock
Blending
a- Process Development
b- manufacturing
Blending Operation: Two Technologies, Two ApproachesProcess Development, Validation and Manufacturing
On-lineInformation Feedback
Well Blended
Discarded
Analysis &Decision making
Blending
Raw Materials
OF
F L
INE
ON
LIN
E
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Blending Data Collected from CAMP Companies
Operation Characteristics
Low Medium High
Cleaning time (min) 20
10
6
250
35
18
480
60
30
60 90 120
6
20
2
30
250
25
60
480
48
Loading time (min)
Discharge time (min)
Sampling time (min)
Transport time (min)
QC Testing time (min)
QC Holding time (min)
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Results
Blending PerformanceProcess Development and Validation
6% no wait between blends
1 Blend 2 Blends 3 Blends
Best
Med.
Worst
2.32
13.19
25.82
0.36
1.31
2.57
4.96
23.45
43.40
0.68
1.93
3.56
8.45
30.65
56.17
1.07
2.41
4.46Tim
e (d
ays)
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Impact of the number of blends on total process time
1.31 1.93
13.19
30.6523.45
2.41
0
10
20
30
40
50
60
1 2 3
Number of blends
Tim
e (d
ays)
Avg Off line Avg On line
Blending PerformanceProcess Development and Validation
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
APPROACH TO LEARNING:
Current Approach Proposed Approach
xx x
x
x
x
x
x
x
x
x
x
xx
xxxx
x
x
xxx
x
xxxxxx
xxxxxxxxxxxx
x
xxxxxxxxx
xxxxxxxxxx
xxxxxxxxxxxx
xx
x
Process Development
Commercial Production
1a
1b
2a
2b
Consequences on Process Development & Commercial Production
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
CQV Opportunity in Process Development
• Process development can be on the critical path• Factor of 10-15 reduction in cycle time in blend
process development (maybe more..)• Variability reduction in blend process dev. time
• independence of organization/product -> predictability…
• Benefits not restricted to use of new on-line sensors• improvement data analysis of existing sensor data• use of this for experimental design
SUMMARY
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
WHAT ARE THE IMPLICATIONS?
CONTINUOUS QUALITY VERIFICATION (CQV)
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
FDA
Pharmaceutical Companies
CAMP
Purdue MIT
• Abbott
• Aventis
• Bristol-Myers Squibb
• Johnson & Johnson
• Hoffmann-La Roche
• Glaxo SmithKline
• Wyeth-Ayerst
Consortium for the Advancement of Manufacturing in Pharmaceuticals (CAMP)
Vendors
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PROCESS A WITH CURRENT QC TESTS AND NEW POSSIBILITIES
WEIGHING WETGRANULATION
STEP FB DRY
STEP
BLEND
ENCAPSULATESIEVE
• API• MICRO
• Particle Size • Description• ID• Assay• CU• Impurity• Dissolution• MICRO
QC1 QC3 QC4
DRY MIX
QC2
• LOD
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Need to Focus on Both Material Flow and Information Flow
BulkActive
BulkFormulation
Filling/Tableting/ etc.
Packaging/Finishing
Sensor1 (or QC test1)
YXY1 Y2 Y3
t 1 t 2 t 3 t 4
Y4
t
Sensor2 (or QC test2) Sensor3 (or QC test3) Sensor4 (or QC test4)
INFORMATION FLOW
MATERIAL FLOW
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Manufacturing Information Management: Has Hardware and Software Components
BulkActive
BulkFormulation
Filling/Tableting/ etc.
Packaging/Finishing
Sensor1 (or QC test1)
YXY1 Y2 Y3
t 1 t 2 t 3 t 4
Y4
t
Sensor2 (or QC test2) Sensor3 (or QC test3) Sensor4 (or QC test4)
0
2
4
6
8
10
12
14
16
18
20
0 50 100 150 200 250
Readings @ 0.375 seconds
Flu
ore
scen
ce S
ign
als,
vo
lts
1:10 powder flow
1:20
y = 1.9757x + 0.4886
R2 = 0.99830.00
5.00
10.00
15.00
20.00
25.00
0.0 2.0 4.0 6.0 8.0 10.0 12.0
% of Triamterene
PMT
Sign
al, v
olts
Mixing Of 1:10 Triamterene-Lactone @ 85%
Fill (10g) And 27.4 RPM
0
5
10
15
20
25
30
35
40
0 50 100 150 200 250 300
Number of Rotations
Sig
nal
s, v
olt
s
0
5
10
15
20
25
30
35
0 50 100 150 200
Number of Readings @ 0.375 s/reading
Sig
nal
, vo
lts
10%
5%
1%
0.5%0.1%
• Fast Response• On-Line• Real-Time• Accurate• Robust
• Rapid Rate of Learning• Short Cycle Times• Benchmarking• Modeling• Continuous Problem Solving
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
BulkActive
BulkFormulation
Filling &Finish Packaging
BulkActive
BulkFormulation
Filling &Finish Packaging
BulkActive
BulkFormulation
Filling &Finish Packaging
Company A
Company B
Company C
HORIZONTAL AND VERTICAL APPROACHES
BlendingDryingGranulation
Fermentation Rapid MicrobialDetection
FlowTabletingTransport
High Vol
Variable
Liquids
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
CQV: BENEFITS
• Data Mining of Process Data
• Data -> Information -> Knowledge
• Rationale for New Sensors
• Variable Categorization: PCCPs, etc.
• Basis for Specifications, Batch Record Design
• Basis for Experimental Design, Etc. …
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Learning Curve: Cycle Times
Total cycle time
10
100
1000
0 50 100 150 200 250 300 350 400 450 500 550 600 650 700
batch #
days
Accelerated Learning Curve Facilitated ByContinuous Quality Verification
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
CQV: SO WHAT?
• On-line sensors doing the same thing will have only incremental impact
• This impact will still be only incremental even if there is an MES/EBR system
• Data Warehousing focused on exceptions canhave a large impact
• On-line sensors + EBR + Data Warehousing can fundamentally change pharma. mfg.
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
PRODUCT LIFE CYCLE: OPPORTUNITIES
7:15 AM Tue, Mar 02, 1999
1.00 8.25 15.50 22.75 30.00
Years
1:
1:
1:
-141.04
114.92
370.88
1: NET INCOME 2: NET INCOME 3: NET INCOME
1
1
1
2
2
2
2
3
3
3
3
Net Income (Untitled Graph)
Reduction of time-to-market
Reduction ofmanufacturing cost
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
Pharmaceutical Manufacturing:Opportunity Areas
• Manufacturing: Cost --> Profit
• Organizational focus: Functional --> Process
• Optimization: Local --> Supply chain
• Inventory Management: JIC --> JIT
• Cost of Quality: Inspection --> Prevention
KEY TECHNOLOGY OPPORTUNITY: On-line Sensors+EBR+Data Warehousing!
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
ACKNOWLEDGEMENTS
• Professor Charles Cooney (MIT)
• Professor Stephen Byrn (Purdue)
• CAMP
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)
NOTE ON CONTEXT
• This presentation does not necessarily represent the views of MIT, Purdue or CAMP
• Some data have been disguised for reasons of sensitivity and confidentiality
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