Professional Documents
Culture Documents
1) Introduction
2) Vertical Take off
3) Process Transfers vs. Technology Transfers
4) Technology Transfer Deliverables
5) Application Techniques for Technology Transfer
6) Technology Transfer Skill Sets
7) Question Answer Session
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1 min
5 min
10 min
5 min
35 min
10 min
10 min
Hometown: Syracuse, NY
Home:
Columbus, OH
Family:
Denise (Wife), Gnther (Son)
Maren (Daughter),Calvin (Son), Olive(dog)
Hobbies:
Sailing, Travel, Olympic Weightlifting
Education: RIT BS - Engineering
BI PMI Ingelheim, Germany
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3
Process Go-Live
Technology
Transfer
Secondary
Development
(fixing issues)
Time
Process Go-Live
Technology
Transfer
Secondary Development
(fixing issues)
Time
The goal of any technology transfer should be to achieve the desired level of
performance quickly and smoothly. Like a jet, the new process takes-off at the
receiving site and delivers the desired heights of performance right from the start
(vertical take-off).
Inefficiency
Process Go-Live
Rework
Waste
Low Yields
Slow Speeds
Unplanned downtime
Technology
Transfer
Unclear roles
Time
There is a cost associated with most Technology Transfers that tends to stay hidden.
The slow, bumpy ramp-up to desired performance represents cash to the business in
the form of wastes, lower product yields , lost sales opportunities and slower return on
investment (ROI).
Confidential
Includes:
Change control, Process Flow, URS, FDS,
IOQ, PQ, Cleaning validation, PV, Training,
SOPs
Includes:
Process transfer plus- Strategic Plan,
Validation master plan, Document
matrix, Supply chain planning, Method
transfer, PDA, CPP,
OPINA
- Two process train transfers every weekend
SPIRIVA
- One transfer 5 years
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One
Process Step
All
Process Steps
() 1)
() 1)
() 1)
() 1)
Initial
Assessment
Customer
Review
Project
Recommendation
& Proposal
Quality
Documents
Complete
Quality Docs
Created
Project
Go
5
6
Ready for
Execution
7
Expansion
Documented
Process
Mapped with
CPP
Project
Plan
Approved
Eng. / Transfer
Batches
Execution
Production
Documents
Completed
Develop
Project
Plan
4
CPP with Gap
Assessment
Validation /
Commercial
Batch
Prepare
for
Validation
8
Ready for
Validation
MFG
Validation.
batches
9
Post-Approval
Assessment /
Post Mortem
Milestones assessed
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Specify ...
scope of transfer (process steps)
technology transfer activities and documentation
qualification & regulatory activities
release as additional manufacturer
Product Transfer Master Plan (PTMP)
Establish PTMP
P1 Stokes Mixer
P2 Stokes Mixer
P1 Stokes Mixer
P2 Stokes Mixer
Pony Mixer
Add P1 and P2
Add P1 and P2
Pony Mixer
Add Mag Stearate
Study*
SS Bin
Manesty Press
Compress 25 mg tablets
Killian Press
Study*
Compress 10 mg tablets
CTD
P7
Metric
Most Favorable
Number of
Worldwide
Primary
Packaging
Configurations
Maximum 3
(e.g. one size clear blister of one
material, one size opaque blister,
one size HDPE bottle)
Less Favorable
Maximum 6
Least Favorable
Above 6
Critical #
4
P7
Packaging
(Primary or
protective
secondary or
functional
having impact
on product
quality)
Bottle packaging configurations are determined by counting the different combinations of bottles and
closures, with consideration of size, product count and materials.
Standard HDPE bottle or standard
Special moisture barrier packaging Special inert atmosphere and
oxygen barrier packaging
PVC and/or PVDC blister suitable. needed (PVDC based materials
required. Novel packaging
inadequate) or if hygroscopic
materials required not
formulation prone to major failure
after HDPE bottle opened or failure commonly used for
pharmaceutical products.
if bottle not reclosed in-use.
Materials not approved for
Special light protective packaging
needed (lined bottles or dark glass). use in food or drug
packaging in US or EU.
Special design or configuration of
HDPE bottles (e.g. desiccant),
Polypropylene bottle, or
Aluminum blister, bag, overwrap
required.
Multiple suppliers available.
Only single supplier available but
Single source supply with
other suppliers can be developed.
patent restrictions against
alternate suppliers.
Bottle: Gap last
Blister foils: Alcan + Constantia
2+
5+
Template
eRoom Folder:
1 Transfer Management
18/102
Handbook for Transfers of Chemical Products V02
GL
Activity
Start Date
End Date
Resp.
Rel.
Set-up Transfer
PL
yes
Set-up Transfer
Set up eRoom
PL
yes
Set-up Transfer
PL
yes
Set-up Transfer
PL
yes
Preparation of TTP
Idemtification of documents
PM RU
yes
Preparation of TTP
Preparation of documents
PM SU
yes
Preparation of TTP
QC SU
yes
Preparation of TTP
P SU
yes
Preparation of TTP
P SU
yes
Preparation of TTP
Check production needs and their compatibility with the actual planning
P SU
yes
Preparation of TTP
P RU
Preparation of TTP
Preparation of TTP
PM RU
P RU
Example
eRoom
Folder:
yes
1yesTransfer Management
yes
Template
eRoom Folder:
2 Tech Transfer
Example
eRoom Folder:
1 Project Management
3)
4)
5)
6)
7)
8)
Sequential or
parallel?
Ensure proper
bonding and
grounding of
equipment.
Ensure vent
bungholes on
both metal
waste drum and
solvent drum
are open
not ok
ok
Where
described
ok
not ok
open them
Do I need to
contact
supervisor
first?
Attach Inlet
hose and Valve
No.2 of CST
system to the
vessel and
record the
weight.
Calculate 95%
of total required
Dehydrated
Alcohol,
USP/EP/BP to
add to the
formulation
vessel
Calculate the
amount of
Dehydrated
Alcohol,
USP/EP/BP to
add to the
vessel via the
CST system
(underfill?)
is this
correct?
confusing to
me..
Calculate 95%
minus the
Underfill
Add this
amount to the
formulation
vessel.
Target transfer
weight of the
vessel achieved
Remove inlet
hose and Valve
No.2 from the
vessel and
record weight.
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CQA
Specification
Clear,colorlesstopale
yellowfreefromvisable
Appearance
Contamination
Volume
Notlessthan16.7mL/Vial
Assay
98.0% 108.0%oflabel
pH
4.0 6.0
Moisture
NMT0.6%
NMT0.05AUatA420nm
Colorofsolution usingethylalcoholblank
Ethanol
90% 110%oflabeledamt
PaclitaxelProductsNMT
0.1%
7EpipaclitaxelNMT0.3%
Limitof
TotalDegredProductsNMT
Degredation
1.0%
ResidualSolvents USP467
NMT0.67EU/mgof
MicrobeTesting Paclitaxel
NMT6,000parts>10micron
ParticulateMatter NMT600parts>25micron
SetUpProcessSubStep
Collect
CheckRoom Check
CheckTank Equipment
Attach Record
for
Isolatorforfor
andcheckfor PitCheck Load Attach IsolatortoTare
Cleanliness Cleanliness Cleanliness Cleanliness
Scale
Isolator CST
tank Wt
Visual,
VisualConf
Setup
Logbook Mork sheet BOM
Challenge Verify
perSOP
Logbookconfconf
Alcohol
Props/
Calibration BOM
Setup Nobreach Printtick
VisualConf VisualConfrinse.
clamp
Verifycal Integrity perSOP alarms
0.5kg
1
1
1
1
1
1
1
3
1
3
5
1
3
3
5
3
1
3
3
5
1
1
3
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
1
1
5
1
1
1
1
1
1
3
5
1
1
1
3
1
1
1
1
1
1
1
5
1
1
1
1
2
1
4
1
1
1
1
1
1
1
1
1
4
1
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Specify ...
scope of transfer (process steps)
technology transfer activities and documentation
qualification & regulatory activities
release as additional manufacturer
Product Transfer Master Plan (PTMP)
Quality Control
Docs complete
Establish PTMP
Product
Receiving Unit
1st step:
Qualification of laboratory
2nd step:
Equivalency check of
product
Product
Sending Unit
Quality Control
Transfer
Test
Sending Unit
Quality Control
Test
Receiving Unit
TTLQ P2
(TTRQC relevant part)
Specify ...
scope of transfer (process steps)
technology transfer activities and documentation
qualification & regulatory activities
release as additional manufacturer
Product Transfer Master Plan (PTMP)
Quality Control
Docs complete
Prepare
Technology Transfer Docs
Establish PTMP
4)
Prepare
Specify scope of Production Transfer
Define Transfer Campaign Size
Execute
Train manufacturing process at SU
Coach manufacturing process at RU
CE Certificate Training Production (CETP)
Parameter
Scale
Target Value
+ 3 3)
Specification
Measured
Value
Sample
No
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Establish PTMP
Specify ...
scope of transfer (process steps)
technology transfer activities and documentation
qualification & regulatory activities
release as additional manufacturer
Product Transfer Master Plan (PTMP)
Quality Control
Docs complete
Prepare
Execute
Technology Transfer Docs Regulatory Activities
Execute Expansion
Document ...
results of technology transfer
results of qualification and regulatory activities
release as additional manufacturer
Product Transfer Master Report (PTMR)
Highest variation
G76757
100.5
G76972
G77267
G77989
assay T [%]
100.0
99.5
99.0
98.5
98.0
97.5
0
10
time [month]
12
14
16
18
20
RACI
35
Questions?
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Reference Sources
*Sources:
A Guide to the Project Management Book of Knowledge, U.S. Department of Defense, 2003
Conclusion
In Compliance
+
On Schedule
+
In Budget
=
SUCCESS !
ProPharma Group is the Best Choice
to balance all three needs!
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CTD
P7
Metric
Most Favorable
Number of
Worldwide
Primary
Packaging
Configurations
Maximum 3
(e.g. one size clear blister of one
material, one size opaque blister,
one size HDPE bottle)
Less Favorable
Maximum 6
Least Favorable
Above 6
Critical at
Milestone #
4
P7
Packaging
(Primary or
protective
secondary or
functional
having impact
on product
quality)
Bottle packaging configurations are determined by counting the different combinations of bottles and
closures, with consideration of size, product count and materials.
Standard HDPE bottle or standard
Special moisture barrier packaging Special inert atmosphere and
oxygen barrier packaging
PVC and/or PVDC blister suitable. needed (PVDC based materials
required. Novel packaging
inadequate) or if hygroscopic
materials required not
formulation prone to major failure
commonly used for
after HDPE bottle opened or
failure if bottle not reclosed in-use. pharmaceutical products.
Materials not approved for
Special light protective packaging
use in food or drug
needed (lined bottles or dark
packaging in US or EU.
glass). Special design or
configuration of HDPE bottles
(e.g. desiccant), Polypropylene
bottle, or Aluminum blister, bag,
overwrap required.
Multiple suppliers available.
Blisterfoils: Alcan + Constantia
Confidential
2+
5+
39
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Appendix A B CD
9 Technology Transfer
Document Flow
Appendix
IChC decision on
Transfer of CP
Product Transfer
Master Plan (PTMP)
Specify
transfer of CP
QC Transfer
Technology Transfer
Protocol QC (TTPQC)
Checklist Laboratory
Equipment (CLLE)
Production Transfer
Specify scope of
Technology Transfer QC
Check equivalency
of laboratory
Checklist
Shipping (CLS)
Laboratory Qualification
Report Part 1 (TTLQ-P1)
Specify qualification
parameters (RU laboratory)
Training Certificates
(CETQC)
Check comparability of
process equipment
Checklist Process
Equipment
Specify equivalency
check
Equivalency Report
Part 1 (TTEQ-P1)
Technology Transfer
Report QC (TTRQC)
Document results of
Technology Transfer - QC
Training Certificates
(CETP)
Coach manufacturing
process at RU
Equivalency Report
Part 2 (TTEQ-P2)
Qualify CP
Document transfer of CP
End
GATE 1
GATE 2
GATE 3
GATE 4
44
GATE 5
GATE 6
GATE 7
GATE 8
45
GATE 9
46
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Tech Transfer
CRC
Application
conceptual
MP Approval
...
Time
Remarks: 1) Start of production of transfer batches; MP Manufacturing Pharma; CRC Change Review Committee; IChC International
48/102
January 17, 2007
Chemicals Committee
Handbook for Transfers of Chemical Products V02
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