approach to technology transfer bob beall
TRANSCRIPT
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Presentation Overview
2Confidential
1) Introduction 1 min
2) Vertical Take off 5 min
3) Process Transfers vs. Technology Transfers 10 min
4) Technology Transfer Deliverables 5 min
5) Application Techniques for Technology Transfer 35 min
6) Technology Transfer Skill Sets 10 min
7) Question Answer Session 10 min
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2. Technology Transfer Success
Successful technology transfer will depend
on your ability to deploy these patterns ofsuccess within your project organization
The slides that follow describe a roadmapyou can follow to optimize your project
organization of technology transfer
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2. Typical Take-Off Curve
Typically, a newly transferred process experiences less than optimal performance at
the start. Like an out-of-tune biplane, the take-off is bumpy, experiencing ups and
downs at the start as the receiving team/site works out the kinks of the new process
and its technology. Performance ramps slowly over time, eventually achieving the
desired level of performance.
Time
Performance
TechnologyTransfer
Process Go-Live
Secondary
Development(fixing issues)
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2. The Concept of Vertical Take-Off
The goal of any technology transfer should be to achieve the desired level ofperformance 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).
Time
Performance
TechnologyTransfer
Process Go-Live
Secondary Development
(fixing issues)
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2. The Value of Vertical Take-Off
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).
Time
Performance
TechnologyTransfer
Process Go-Live
$Low Yields
Inefficiency
Rework
WasteSlow Speeds
Unplanned downtime
Unclear roles
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3) Process transfers vs. Technology transfers
Process Transfer is the transfer of process information, or capability, associatedwith process from a donor side (knowledge center) to a receptor side. The process is
learned and realized by both sides and complies all the regulatory requirements in
terms of Efficacy, Quality and Safety.
Technology Transfer, also called Transfer of Technology (TOT) is the process ofskill transferring, knowledge, technologies, methods of manufacturing, samples of
manufacturing to ensure that scientific and technological developments areaccessible to a wider range of users who can then further develop and exploit the
technology into new products, processes, applications, materials or services. It is
closely related to (and may arguably be considered a subset of) knowledge transfer.
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3) Technology Transfers vs. Process Transfers
A) Process Transfer examples B) Technology Transferexamples
Bi-Layer tablet compression for FDC
DPI encapsulation
Gamma radiation sterilization for parenteralproducts
Includes:
Change control, Process Flow, URS, FDS,IOQ, PQ, Cleaning validation, PV, Training,
SOPs
OPINA- Two process train transfers every weekend
API manufacturing technology
NDA Product manufacturing
ANDA Product transfer
Includes:
Process transfer plus- Strategic Plan,Validation master plan, Document
matrix, Supply chain planning, Method
transfer, PDA, CPP,
SPIRIVA- One transfer 5 years
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3) Technology Transfers vs. Process Transfers
OPINA Process Transfer
Project Objective Consolidate North American pharmaceutical processing in 1 plant
Special Boundaries- No stockpiling of inventory
Solution Transfer two process trains and ancillary equipment every weekend for 5weekends
Method Dedicated transfer team developed plan for 6 months prior to execution.
- Process transfer was like for like.
- All non production transfer activities (training, utility installation, method
transfers, RM transfers, qualification documents completed prior to transfer.- Minute by minute (micro) plan developed with video tape test runs.
- Easiest transfer first.
- Post mortem review of each process to fine tune for next transfer.
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3) Technology Transfers vs. Process Transfers
SPIRIVA Technology Transfer
Project Objective Create redundant US production facility for German blockbuster
Special Boundaries-Process not defined, 1 billion x18 g capsule fill.
Solution Mirror German implementation with 6 month lag.Method Dedicated team, Clear roles and responsibilities.
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4) Technology Transfer Deliverables
In order to specify or to document the results of the technology transfer in a flexible
manner, a TTP or TTR could cover the technology transfer of one or all process steps 1).
Required documents detailing the technology transfer are listed in the Appendix of the
TTP or TTR.Technology Transfer Documentation One
Process StepAll
Process Steps
Prepare Technology Transfer
Technology Transfer Protocol Quality Control () 1)
Laboratory Qualification Report - Part 1 (TTLQ-Part1)
Checklist 'Laboratory Equipment (CLLE)
Checklist 'Raw Material Specifications (CLRMS)
Checklist 'Shipping (CLS)
Technology Transfer Protocol Production (TTPP) () 1)
Equivalency Report Part 1 (TTEQ-Part1)
Checklist Process Equipment (CLPE)
Execute Technology Transfer
Technology Transfer Report Quality Control () 1)
Laboratory Qualification Report - Part 2 (TTLQ-Part2)
Technology Transfer Report Production (TTRP) () 1)
Equivalency Report Part 2 (TTEQ-Part2)
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9 Gate Technology Transfer Approach
13
Initial
Assessment 1
ProjectRecommendation
& Proposal
Customer
Review 2
ProjectGo
Develop
Project
Plan3
ProjectPlan
Approved
Process
Mapped with
CPP4
CPP with GapAssessment
Quality DocsCreated 5
QualityDocuments
Complete
Execution 7
ExpansionDocumented
Prepare
for
Validation8
Ready forValidation
MFG
Validation.
batches9
Post-ApprovalAssessment /Post Mortem
Production
Documents
Completed
6
Ready forExecution
Project
Opportunity
Eng. / TransferBatches
Validation /CommercialBatch
Milestones assessed
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5) Application Techniques for Technology Transfers
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Gate 1. Project Charter -Scope of Transfer Process
Project Recommendation includes the following components:
1) Safety assessment
2) Quality assessment
3) Financial assessment
4) Overall Timeline
5) Framework for Technical Transfer Plan
6) Defines project boundaries What is in scope, what is out of scope
7) Risks and Opportunities identified.
5) Application Techniques for Technology Transfers
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Gate 1. Project Recommendation -Scope of Transfer Process
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
The Master Documentation provides the framework for the transfer process. The Product Transfer Master Plan (PTMP) scope
document defines the boundaries of the transfer.
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Gate 1. Gate 1. Project Recommendation Know what you aretransferring.
P1 Stokes Mixer
Add MCC, API, Dextrose
and Starch, Mix for 5 min
Pony Mixer
Add P1 and P2
Mix for 10 min
Pony Mixer
Add Mag Stearate
Mix for 5 min
Poly Lined Drum
Transfer Blend through #10 screen
Manesty Press
Compress 25 mg tablets
SS Bin
Transfer Blend through
#10 screen
Killian Press
Compress 10 mg tablets
Sending Site Process Receiving Site Process
Study*
P2 Stokes Mixer
Add MCC, API, Dextrose
and Starch, Mix for 5 min
P1 Stokes Mixer
Add MCC, API, Dextrose
and Starch, Mix for 5 min
Pony Mixer / Blend Cube
Add P1 and P2
Mix for 10 min
Pony Mixer / Blend Cube
Add Mag Stearate
Mix for 5 min
P2 Stokes Mixer
Add MCC, API, Dextrose
and Starch, Mix for 5 min
These processes have the same SUPAC classification per CDER
This product transfer will be filed as a CBE 30
Study*
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Gate 1. Project Recommendation Know what you are transferringvs. Company Metrics
CTD Metric Most Favorable Less Favorable Least Favorable Critical #
Comment
P7 Number ofWorldwide
Primary
Packaging
Configurations
Maximum 3(e.g. one size clear blister of one
material, one size opaque blister,
one size HDPE bottle)
Maximum 6
2 blister (7-ct push + 10-ct peel-
push)
2 bottles 60mL + 120mL
Above 6 4
The number of worldwide primary packaging configurations reported here is determined for each drug
product dosage form and strength.
Blister packaging configurations are determined by counting the different combinations of forming and
lidding materials being developed with consideration of the sealing area and perforations. Although the
number of tablets per blister is not considered when determining the number of worldwide primary
packaging configurations being developed, this aspect must be evaluated and taken into considerationduring capacity, transfer and launch planning by Operations.
Bottle packaging configurations are determined by counting the different combinations of bottles and
closures, with consideration of size, product count and materials.
P7 Packaging
(Primary or
protective
secondary or
functional
having impact
on product
quality)
Standard HDPE bottle or standard
PVC and/or PVDC blister suitable.
Special moisture barrier packaging
needed (PVDC based materials
inadequate) or if hygroscopic
formulation prone to major failure
after HDPE bottle opened or failure
if bottle not reclosed in-use.
Special light protective packaging
needed (lined bottles or dark glass).
Special design or configuration of
HDPE bottles (e.g. desiccant),
Polypropylene bottle, or
Aluminum blister, bag, overwrap
required.
Special inert atmosphere and
oxygen barrier packaging
required. Novel packaging
materials required not
commonly used for
pharmaceutical products.
Materials not approved for
use in food or drug
packaging in US or EU.
2+
Multiple suppliers available.
Blister foils: Alcan + Constantia
Only single supplier available but
other suppliers can be developed.
Bottle: Gap last
Single source supply with
patent restrictions against
alternate suppliers.
5+
Product Design Attribute (PDA) TABLES
5) Application Techniques for Technology Transfers
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Handbook for Transfers of Chemical Products V02
18/102 January 17, 2007
Gate 2. Project Go
In order to support the documentation of the decision to execute technical
transfer the Decision' template specifies format and content.
Template
eRoom Folder:
1 Transfer Management
Technology Transfer
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Gate 3. Project PlanThe checklist 'Activities' (CLA) contains a proposal regarding activities which are in
principle relevant for a transfer. Relevant activities can be marked and copied to the
project plan.
Transfer of Chemical Product - Checklist 'Activites'
Process Step GL Activity Start Date End Date Resp. Rel.
Set-up Transfer 2 Set up transfer project PL yes
Set-up Transfer 2 Set up eRoom PL yes
Set-up Transfer 2 Denominate transfer team PL yes
Set-up Transfer 2 Prepare kick-off meeting PL yes
Preparation of TTP 2 Idemtification of documents PM RU yes
Preparation of TTP 2 Preparation of documents PM SU yes
Preparation of TTP 2 Preparation of TTP - Quality Control QC SU yes
Preparation of TTP 2Acquisi tion and evaluation of the exist ing documentation on the synthetic
method, including eventual batch recordsP SU yes
Preparation of TTP 2Acquisi tion and evaluation of general documentation about ritical
parameters or of a complete development reportP SU yes
Preparation of TTP 2 Check production needs and their compatibility with the actual planning P SU yes
Preparation of TTP 2Feasibility analysis in plant on the existing documentation and lay-out
hypothesis of the processP RU yes
Preparation of TTP 2 Cost analysis on production hypothesis PM RU yes
Preparation of TTP 2Acquisi tion and evaluation of the safety documentation of the process ,
including MSDSP RU yes
Example
eRoom Folder:
1 Transfer Management
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Gate 3. Project Plan
Template
In order to specify the product transfer, the Product Transfer Master Plan (PTMP)
template provides predefined structure, format and content.
eRoom Folder:
2 Tech Transfer
5) Application Techniques for Technology Transfers
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Gate 3. Project PlanMS Project serves as standard tool for the project planning of the product transfer. In
order to accelerate the preparation of the project plan, tasks from the activity list could
be pasted in.
Example
eRoom Folder:
1 Project Management
5) Application Techniques for Technology Transfers
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Gate 4. Process Flow
oknot ok
Conduct thePre-Use Flush
for the ClosedSolventTransferSystem
Ensure ventbungholes on
both metalwaste drum and
solvent drumare open
Ensure properbondingandgroundingofequipment.
Sequential orparallel?
ok
not ok
Wheredescribed
open them
Do Ineedtocontact
supervisorfirst?
Attach Inlethose andValve
No.2 ofCSTsystem to the
vessel andrecordthe
weight.
Calculate 95%oftotal required
DehydratedAlcohol,
USP/EP/BP toaddtotheformulation
vessel
Calculatet heamount of
DehydratedAlcohol,
USP/EP/BP toaddto the
vessel via theCSTsystem(underfill?)
Calculate95%minus theUnderfill
is thiscorrect?
confusing tome..
Addthisamount to theformulation
vessel.
Continue agitation throughout solvent transfer
Remove inlethose and ValveNo.2from the
vessel andrecordweight.
Target transferweight ofthe
vessel achieved
1) Map production process with SME / Operators
2) Identify Critical Process Parameters (CPP) and Critical
Quality Attributes (CQA) as they relate to finishedproduct
3) Confirm all CPP / CQA have studies to support
acceptance ranges.
4) Conduct studies to confirm CPP / CQA ranges to fill
gaps
5) Determine best practice / gold standard process6) Create CPP / CQA database (PANDA)
7) Compare CPP / CQA data values to gold standard
and ranges to determine cause of variance.
8) Provide real time data trending to operators to enable
educated process adjustment.
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Formulation SetUpProcessSubStep
CheckRoom
for
Cleanliness
Check
Isolatorfor
Cleanliness
CheckTank
for
Cleanliness
Collect
Equipment
andcheckfor
Cleanliness
PitCheck
Scale
Load
Isolator
Attach
CST
Attach
Isolatorto
tank
Record
Tare
Wt
CQA Specification
Logbookconf
VisualConf
Logbook
conf
VisualConf
Visual,
Mork sheet
Alcohol
rinse.
VisualConf
BOM
Props/
clamp
Challenge
Calibration
Verifycal
Verify
BOM
Integrity
Setup
perSOP
Setup
perSOP
Nobreach
alarms
Printtick
0.5kg
Appearance
Clear,colorlesstopale
yellowfreefromvisable
Contamination 1 1 5 3 1 1 1 1 1
Volume Notlessthan16.7mL/Vial 1 1 1 1 1 1 1 1 1
Assay 98.0%108.0%oflabel 1 3 3 3 3 1 1 1 5
pH 4.06.0 1 1 3 3 1 1 1 1 1
Moisture NMT0.6% 1 3 5 5 1 1 1 2 1
Colorofsolution
NMT0.05AUatA420nm
usingethylalcoholblank 1 1 3 1 1 1 1 1 1
Ethanol 90%110%oflabeledamt 1 1 5 1 3 1 1 1 5
Limitof
Degredation
PaclitaxelProductsNMT
0.1%
7EpipaclitaxelNMT0.3%
TotalDegredProductsNMT
1.0% 1 1 2 4 1 1 1 1 4
ResidualSolvents USP467 1 1 1 1 1 1 1 1 1
Microbe
Testing
NMT0.67EU/mgof
Paclitaxel 3 3 5 3 1 3 1 2 1
ParticulateMatter
NMT6,000parts>10micron
NMT600parts>25micron 1 1 1 1 1 1 1 1 1
Gate 4. CPP / CQA Matrix
Based on ICH Q9 Guidelines
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Gate 5. QC Documents Completed
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
QC Documentation must be set prior to process transfer
Quality Control
Docs complete
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Gate 5. QC Documents Completed
Quality Control
Production
Test
Sending Unit
Test
Receiving Unit
Product
Sending Unit
Product
Receiving Unit1st step:
Qualification of laboratory(Parallel analysis of referencesubstance by SU and RU)
2nd step:Equivalency check of
product(Comparison of transfer batches
with reference batches)
Production Transfer
The technology transfer products starts with the qualification of the laboratory (QC
Transfer) and continues with the transfer of the manufacturing process (Production
Transfer). The equivalency check of the chemical product has to be performed by the
QC of the Sending Unit
1)
.
Quality ControlTransfer
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Gate 5. QC Documents CompletedThe Part 2 of the Technology Laboratory Qualification Report (TTLQ) template
supports to record the analytical results obtained in the parallel analysis by the RU, to
document the comparison of the results and the conclusions with regard to the
fulfillment of the acceptance criteria.
Example
TTLQ P2
(TTRQC relevant part)
eRoom Folder: 3 Quality Control
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Gate 6. Expansion Documents Completed
Specify ...
scope of transfer (process steps)
technology transfer activities and documentation
qualification & regulatory activities
release as additional manufacturer
Product Transfer Master Plan (PTMP)
Prepare
Technology Transfer Docs
Establish PTMP
Quality Control
Docs complete
5) Application Techniques for Technology Transfers
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January 17, 2007
The technology related part of the transfer is documented in technology transfer
documentation. Technology Transfer - ProductionTechnology Transfer Quality Control
PreparePrepare
Execute
Execute
Specify scope of QC Transfer1)
TT Protocol Quality Control (TTPQC)
Check equivalence of laboratory CL Laboratory Equipment (CLLE)
Check raw material specifications at
CL Raw Material Specifications (CLRMS)
Ship reference substances to RU
CL Shipping (CLS)
Specify qualification of RU laboratory
TT Laboratory QualificationPart 1 (TTLQ-P1)
Train analytical methods at SU3)
CE Certificate Training Quality Control
Execute parallel analysis at RU
TT Laboratory QualificationPart 2 (TTLQ-P2)
Document results of QC Transfer
TT Report Quality Control (TTRQC)
Specify scope of Production Transfer4)
Define Transfer Campaign Size
TT Protocol Production (TTPP)
Check equivalence of process
CL Process Equipment (CLPE)
Specify equivalency check5)
TT Equivalency QualificationPart 1 (TTEQ-P1)
Train manufacturing process at SU
Coach manufacturing process at RU
CE Certificate Training Production (CETP)
Produce transfer campaign at RU
Execute equivalency check
TT Equivalency QualificationPart 2 (TTEQ-P2)
Document results of Production
TT Report Production (TTRP)
Gate 6. Expansion Documents Completed
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Gate 6. Expansion Equivalency Check
Target Value
NormalOperating Range
ProvenAcceptable Range
KnowledgeRange
ParameterScale
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30/102
The equivalency check has to be conducted for non critical parameters by min/max
comparison.
For critical parameters QC Charts 1) have to be used to demonstrate equivalency.Production RUProduction SU
Specification
SampleNo
+ 3 3)
Upper Tolerance Limit (UTL) 2)
Lower Tolerance Limit (LTL) 2)
Upper Specification Limit (USL)
Lower Specification Limit (LSL)
MeasuredValue
Remarks: 1) upper or upper/lower limited control chart 2) Synonym: Upper/ Lower Control Limit; 3) 99,7% of the data should lie within the tolerance limits, the probability of afalse decision is 0,3%
EXAMPLE
Gate 6. Expansion Equivalency Check
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Gate 7. Expansion Completed
Specify ...
scope of transfer (process steps)
technology transfer activities and documentation
qualification & regulatory activities
release as additional manufacturer
Product Transfer Master Plan (PTMP)
Prepare
Technology Transfer Docs
Establish PTMP
Execute
Regulatory Activities
Quality Control
Docs complete
Execute Expansion Document ...
results of technology transfer
results of qualification and regulatory activities
release as additional manufacturer
Product Transfer Master Report (PTMR)
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Gate 8. Validation / Stability
1) Never fail validation / stability batches.
Highest variation
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Gate 8. Validation / Stability
1) Never fail validation / stability batches.
Degradation T @ 25C/60% r.H.
97.5
98.0
98.5
99.0
99.5
100.0
100.5
101.0
0 2 4 6 8 10 12 14 16 18 20
time [month]
assayT[%]
G76757
G76972
G77267
G77989
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Gate 9 Post Approval Assessment / Post Mortem
5) Application Techniques for Technology Transfers
1. Review deliverables vs. plan
2. Review budget vs. plan
3. Review timeline vs. Base Plan
4. Revise templates accordingly.
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6) Technology transfer skill sets
Management, Safety, QA, QC, Finance, Change Management, Engineering, Micro, Validations,
Operations, Customer, Contract Management, DRA
RACI
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Questions?
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Reference Sources *Sources:
Project Management Best-Practice Report, APQC, 2004
A Guide to the Project Management Book of Knowledge, U.S. Department of Defense, 2003
European Technology Transfer Guide to Best Practice, Teurpin, 2001
Benchmarking Best-Practices in Technology Transfer, Colorado Institute for Technology Transfer
and Implementation, 1993
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In Compliance
+
On Schedule
+
In Budget
=
SUCCESS !
ProPharma Group is the Best Choice
to balance all three needs!
Conclusion
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CTD Metric Most Favorable Less Favorable Least FavorableCritical at
Milestone #
Comment
P7 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)
Maximum 6
2 blister (7-ct push + 10-ct peel-
push)
2 bottles 60mL + 120mL
Above 6 4
The number of worldwide primary packaging configurations reported here is determined for each drug
product dosage form and strength.Blister packaging configurations are determined by counting the different combinations of forming and
lidding materials being developed with consideration of the sealing area and perforations. Although the
number of tablets per blister is not considered when determining the number of worldwide primary
packaging configurations being developed, this aspect must be evaluated and taken into consideration
during capacity, transfer and launch planning by Operations.
Bottle packaging configurations are determined by counting the different combinations of bottles and
closures, with consideration of size, product count and materials.
P7 Packaging
(Primary or
protectivesecondary or
functional
having impact
on product
quality)
Standard HDPE bottle or standard
PVC and/or PVDC blister suitable.
Special moisture barrier packaging
needed (PVDC based materials
inadequate) or if hygroscopicformulation prone to major failure
after HDPE bottle opened or
failure if bottle not reclosed in-use.
Special light protective packaging
needed (lined bottles or dark
glass). Special design or
configuration of HDPE bottles
(e.g. desiccant), Polypropylene
bottle, or Aluminum blister, bag,
overwrap required.
Special inert atmosphere and
oxygen barrier packaging
required. Novel packagingmaterials required not
commonly used for
pharmaceutical products.
Materials not approved for
use in food or drug
packaging in US or EU.
2+
Multiple suppliers available.
Blisterfoils: Alcan + Constantia
Only single supplier available butother suppliers can be developed.
Bottle: Gaplast
Single source supply withpatent restrictions against
alternate suppliers.
5+
Product Design Attribute (PDA) TABLES
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5) Technology Transfer Skill Sets
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3) Process transfers vs. Technology transfers
Trouble -Typically both process transfers and technology transfer projects get intotrouble because:
1) Process was not Right the first time before the transfer.2) Process technology was not up to date technology before transfer.3) Resolve compliance issues during transfer.
Result Extended timelines, cost overrun.
Appendix
A B CDAppendix
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Appendix
9 Technology Transfer Document Flow
Jan 17, 2008Handbook for Transfer of Chemical Products
A B CDpp
9 Technology Transfer Document Flow1)
IChC decision on
Transfer of CPIChC Decision (FID)
Specifytransfer of CP
Specify scope of
Technology Transfer QC
Product TransferMaster Plan (PTMP)
Check equivalencyof laboratory
Check adequacy of raw
material specifi cations RU/SU
Ship reference substances
to RU
Specify qualifi cation
parameters (RU laboratory)
Execute parallel analysis
at RU
Coach analytical methods atRU (optional)
Document results ofTechnology Transfer - QC
Train analytical methods
at SU
Specify scope of Technology
Transfer Production
Define Transfer CampaignSize
Check comparability of
process equipment
Specify equivalencycheck
Produce transfer campaign
at RU
Train manufacturing
process at SU
Execute equivalency check
Coach manufacturing
process at RU
Document results of Techn.
Transfer - Production
Document transfer of CP
Technology TransferProtocol QC (TTPQC)
Checklist LaboratoryEquipment (CLLE)
Checklist Raw MaterialSpecifications (CLRMS)
ChecklistShipping (CLS)
Laboratory QualificationReport Part 1 (TTLQ-P1)
Quali fy CP
Techn. Transfer ProtocolProduction (TTPP)
Execute Regulatory Activities
Checklist Process
Equipment
Equivalency Report
Part 1 (TTEQ-P1)
Training Certificates(CETP)
Training Certificates(CETQC)
Laboratory QualificationReport Part 2 (TTLQ-P2)
Technology TransferReport QC (TTRQC)
Equivalency Report
Part 2 (TTEQ-P2)
Techn. Transfer ReportProduction (TTRP)
Product TransferMaster Report (PTMR)
End
Remarks: CPChemical Product; 1) for more detail s please see Handbook
Production TransferQC Transfer
North to Phase V Product Transfers:
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GATE 4
GATE 3
GATE 2
GATE 1
North to Phase V Product Transfers:
Project Phases / Responsibilities
North to Phase V Product Transfers:
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GATE 8
GATE 7
GATE 6
GATE 5
North to Phase V Product Transfers:
Project Phases / Responsibilities
North to Phase V Product Transfers:
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Project Phases / Responsibilities
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3) Technology transfer deliverables
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Handbook for Transfers of Chemical Products V02
48/102 January 17, 2007
Scope of Transfer Process (1)
Establish Product Transfer Master Plan
Prepare Technology Transfer QC
Execute Technology Transfer QC
IChC decision (Start)
Execute Technology Transfer Production
Release as additional Manufacturer (End)
...
Qualify API (by MP)
CRC
ApplicationEstablish Product Transfer Master
Report
Remarks: 1) Start of production of transfer batches; MP Manufacturing Pharma; CRC Change Review Committee; IChC International
Chemicals Committee
Tech Transfer
Execute regulatory activities
Laboratory Qualification 1)
Equivalency of API
Time
Prepare Technology Transfer Production
MP Approval
...
The Tech Transfer starts with a decision to transfer continues with the transfer of
(documented) knowledge, the demonstration of ability of the receiving unit to
manufacture the product to the satisfaction of all involved parties and ends with
successfully regulatory variations and the release as additional manufacturer.
Manage project
conceptual
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