Download - Approach to Technology Transfer
Presentation Overview
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1) Introduction 1 min 2) Vertical Take off 5 min3) Process Transfers vs. Technology Transfers 10 min4) Technology Transfer Deliverables 5 min5) Application Techniques for Technology Transfer 35 min6) Technology Transfer Skill Sets 10 min7) Question Answer Session 10 min
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1.0 Introduction - Robert Beall
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Boehringer – Ingelheim Transfer Experience 1997-2000 BIRI -Columbus, OH Solids Transfer Engineer for Optimization in North America (OPINA)2000-2007 BIRI Product transfers (Mobic, Spiriva, Micardis Plus) from (BIPKG) to USA (BIRI) . 2007–2010 BIPKG International transfer between Germany and India for WW distribution. 2010–2011 BVL Life-Cycle product transfer of parenteral manufacturing to new facility.
Hometown: Syracuse, NYHome: Columbus, OHFamily: Denise (Wife), Günther (Son)
Maren (Daughter),Calvin (Son), Olive(dog) Hobbies: Sailing, Travel, Olympic WeightliftingEducation: RIT BS - Engineering
BI PMI – Ingelheim, Germany
2. Technology Transfer Success
• Successful technology transfer will depend on your ability to deploy these patterns of success within your project organization
• The slides that follow describe a roadmap you can follow to optimize your project organization of technology transfer
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
Technology Transfer
Process Go-Live
Secondary Development (fixing issues)
2. The Concept of Vertical Take-Off
• 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).
Time
Performance
Technology Transfer
Process Go-Live
Secondary Development (fixing issues)
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
Technology Transfer
Process Go-Live$
Low Yields
Inefficiency
Rework
Waste Slow Speeds
Unplanned downtime
Unclear roles
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3) Process transfers vs. Technology transfersProcess Transfer is the transfer of process information, or capability, associated with 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 of skill transferring, knowledge, technologies, methods of manufacturing, samples of manufacturing to ensure that scientific and technological developments are accessible 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 TransfersA) Process Transfer examples B) Technology Transfer examplesBi-Layer tablet compression for FDCDPI encapsulationGamma radiation sterilization for parenteral products
Includes: Change control, Process Flow, URS, FDS, IOQ, PQ, Cleaning validation, PV, Training, SOP’s
OPINA - Two process train transfers every weekend
API manufacturing technologyNDA Product manufacturingANDA 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 TransferProject 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 5
weekendsMethod – 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 TransferProject Objective – Create redundant US production facility for German blockbuster Special Boundaries-Process not defined, 1 billion x18 µg capsule fill. Solution – Mirror German implementation with 6 month lag.Method – Dedicated team, Clear roles and responsibilities.
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 TransferTechnology 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 TransferTechnology Transfer Report – Quality Control () 1)
Laboratory Qualification Report - Part 2 (TTLQ-Part2)
Technology Transfer Report – Production (TTRP) () 1)
Equivalency Report – Part 2 (TTEQ-Part2)
9 Gate Technology Transfer Approach
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InitialAssessment 1
Project Recommendation
& Proposal
Customer Review 2
Project Go
Develop Project
Plan3
Project Plan
Approved
ProcessMapped with
CPP4
CPP with Gap Assessment
Quality Docs Created 5
QualityDocuments
Complete
Execution 7Expansion
Documented
Prepare for
Validation8
Ready forValidation
MFG Validation.
batches9
Post-Approval Assessment / Post Mortem
Production Documents Completed
6Ready for Execution
Project Opportunity
Eng. / Transfer Batches Validation /
Commercial Batch
Milestones assessed
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5) Application Techniques for Technology Transfers
Gate 1. Project Charter -Scope of Transfer Process
Project Recommendation includes the following components:1) Safety assessment2) Quality assessment3) Financial assessment4) Overall Timeline5) Framework for Technical Transfer Plan6) Defines project boundaries – What is in scope, what is out of scope7) Risks and Opportunities identified.
5) Application Techniques for Technology Transfers
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.
5) Application Techniques for Technology Transfers
Gate 1. Gate 1. Project Recommendation –Know what you are transferring.
P1 Stokes MixerAdd MCC, API, Dextrose
and Starch, Mix for 5 min
Pony MixerAdd P1 and P2
– Mix for 10 min
Pony MixerAdd Mag Stearate
– Mix for 5 min
Poly Lined DrumTransfer Blend through #10 screen
Manesty PressCompress 25 mg tablets
SS BinTransfer Blend through
#10 screen
Killian PressCompress 10 mg tablets
Sending Site Process Receiving Site Process
Study*
P2 Stokes MixerAdd MCC, API, Dextrose
and Starch, Mix for 5 min
P1 Stokes MixerAdd MCC, API, Dextrose
and Starch, Mix for 5 min
Pony Mixer / Blend CubeAdd P1 and P2
– Mix for 10 min
Pony Mixer / Blend CubeAdd Mag Stearate
– Mix for 5 min
P2 Stokes MixerAdd 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*
5) Application Techniques for Technology Transfers
Gate 1. Project Recommendation –Know what you are transferring vs. Company Metrics
CTD Metric Most Favorable Less Favorable Least Favorable Critical #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 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
Handbook for Transfers of Chemical Products V0218/102 January 17, 2007
Gate 2. Project GoIn 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
5) Application Techniques for Technology Transfers
Gate 3. Project Plan The 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 2 Acquisition and evaluation of the existing documentation on the synthetic method, including eventual batch records
P SU yes
Preparation of TTP 2 Acquisition and evaluation of general documentation about ritical parameters or of a complete development report
P SU yes
Preparation of TTP 2 Check production needs and their compatibility with the actual planning P SU yes
Preparation of TTP 2 Feasibility analysis in plant on the existing documentation and lay-out hypothesis of the process
P RU yes
Preparation of TTP 2 Cost analysis on production hypothesis PM RU yes
Preparation of TTP 2 Acquisition and evaluation of the safety documentation of the process, including MSDS
P RU yes
Example
eRoom Folder: 1 Transfer Management
5) Application Techniques for Technology Transfers
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
Gate 3. Project Plan MS 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 Flushfor the Closed
SolventTransferSystem
Ensure ventbungholes on
both metalwaste drum and
solvent drumare open
Ensure properbonding andgrounding ofequipment.
Sequential orparallel?
oknot ok
Wheredescribed
open them
Do I need tocontact
supervisorfirst? Attach Inlet
hose and ValveNo.2 of CSTsystem to the
vessel andrecord the
weight.
Calculate 95%of total required
DehydratedAlcohol,
USP/EP/BP toadd to theformulation
vessel
Calculate theamount of
DehydratedAlcohol,
USP/EP/BP toadd to the
vessel via theCST system(underfill?)
Calculate 95%minus theUnderfill
is thiscorrect?
confusing tome..
Add thisamount to the
formulationvessel.
Continue agitation throughout solvent transfer
Remove inlethose and ValveNo.2 from the
vessel andrecord weight.
Target transferweight of the
vessel achieved
1) Map production process with SME / Operators 2) Identify Critical Process Parameters (CPP) and Critical
Quality Attributes (CQA) as they relate to finished product
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.
5) Application Techniques for Technology Transfers
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Formulation Set Up Process Sub‐Step
Check Room for Cleanliness
Check Isolator for Cleanliness
Check Tank for Cleanliness
Collect Equipment and check for Cleanliness
Pit Check Scale
Load Isolator
Attach CST
Attach Isolator to
tank
Record Tare Wt
CQA SpecificationLogbook confVisual Conf
Logbook confVisual Conf
Visual,Mork sheetAlcohol rinse.
Visual ConfBOM ‐Props / clamp
Challenge Calibration Verify cal
Verify BOMIntegrity
Set up per SOP
Set up per SOP‐No breach alarms
Print tick0.5 kg
Appearance
Clear, colorless to paleyellow free from visable Contamination 1 1 5 3 1 1 1 1 1
Volume Not less than 16.7 mL/Vial 1 1 1 1 1 1 1 1 1Assay 98.0% ‐ 108.0% of label 1 3 3 3 3 1 1 1 5pH 4.0 ‐ 6.0 1 1 3 3 1 1 1 1 1Moisture NMT 0.6% 1 3 5 5 1 1 1 2 1
Color of solutionNMT 0.05 AU at A420 nm using ethyl alcohol blank 1 1 3 1 1 1 1 1 1
Ethanol 90% ‐ 110% of labeled amt 1 1 5 1 3 1 1 1 5
Limit of Degredation
Paclitaxel Products NMT 0.1%7 Epipaclitaxel NMT 0.3%Total Degred Products NMT 1.0% 1 1 2 4 1 1 1 1 4
Residual Solvents USP 467 1 1 1 1 1 1 1 1 1
Microbe TestingNMT 0.67 EU/mg of Paclitaxel 3 3 5 3 1 3 1 2 1
Particulate MatterNMT 6,000 parts > 10 micronNMT 600 parts > 25 micron 1 1 1 1 1 1 1 1 1
Gate 4. CPP / CQA Matrix
Based on ICH Q9 Guidelines
5) Application Techniques for Technology Transfers
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 ControlDocs complete
5) Application Techniques for Technology Transfers
Gate 5. QC Documents Completed
Quality Control
Production
Test Sending Unit
Test Receiving Unit
Product Sending Unit
Product Receiving Unit 1st step:
Qualification of laboratory(Parallel analysis of reference substance 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 Control Transfer
5) Application Techniques for Technology Transfers
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
5) Application Techniques for Technology Transfers
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 ControlDocs complete
5) Application Techniques for Technology Transfers
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 Transfer 1)
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 Qualification–Part 1’ (TTLQ-P1)
Train analytical methods at SU 3)
CE ‘Certificate Training – Quality Control’
Execute parallel analysis at RU TT ‘Laboratory Qualification–Part 2’ (TTLQ-P2)
Document results of QC Transfer TT Report – Quality Control (TTRQC)
Specify scope of Production Transfer 4)
Define Transfer Campaign Size TT Protocol – Production (TTPP)
Check equivalence of process CL ‘Process Equipment (CLPE)
Specify equivalency check 5)
TT ‘Equivalency Qualification–Part 1’ (TTEQ-P1)
Train manufacturing process at SUCoach manufacturing process at RU CE ‘Certificate Training – Production’ (CETP)
Produce transfer campaign at RU
Execute equivalency check TT ‘Equivalency Qualification–Part 2’ (TTEQ-P2)
Document results of Production TT Report –Production (TTRP)
Gate 6. Expansion Documents Completed5) Application Techniques for Technology Transfers
Gate 6. Expansion Equivalency Check
Target Value
NormalOperating Range
ProvenAcceptable Range
KnowledgeRange
ParameterScale
5) Application Techniques for Technology Transfers
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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
Spe
cific
atio
n
Sample No
+ 3 3)
Upper Tolerance Limit (UTL) 2)
Lower Tolerance Limit (LTL) 2)
Upper Specification Limit (USL)
Lower Specification Limit (LSL)
Measured Value
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 a false decision is 0,3%
EXAMPLE
Gate 6. Expansion Equivalency Check 5) Application Techniques for Technology Transfers
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)
PrepareTechnology Transfer Docs
Establish PTMP
Execute Regulatory Activities
Quality ControlDocs complete
Execute Expansion Document ...
• results of technology transfer
• results of qualification and regulatory activities
• release as additional manufacturer
Product Transfer Master Report’ (PTMR)
5) Application Techniques for Technology Transfers
Gate 8. Validation / Stability
1) Never fail validation / stability batches.
Highest variation
5) Application Techniques for Technology Transfers
Gate 8. Validation / Stability
1) Never fail validation / stability batches.
Degradation T @ 25°C/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]
assa
y T
[%]
G76757
G76972
G77267
G77989
5) Application Techniques for Technology Transfers
Gate 9 Post Approval Assessment / Post Mortem 5) Application Techniques for Technology Transfers
1. Review deliverables vs. plan2. Review budget vs. plan3. Review timeline vs. Base Plan4. 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
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
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 Favorable Critical 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 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.
Blisterfoils: Alcan + Constantia
Only single supplier available but other suppliers can be developed.Bottle: Gaplast
Single source supply with patent 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 transfersTrouble -Typically both process transfers and technology transfer projects get into trouble 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.
Appendix9 Technology Transfer –
Document Flow
Jan 17, 2008Handbook for Transfer of Chemical Products
A B CDAppendix9 Technology Transfer –Document Flow1)
IChC decision on Transfer of CP
IChC Decision (FID)
Specify transfer of CP
Specify scope of Technology Transfer –QC
Product Transfer Master Plan’ (PTMP)
Check equivalency of laboratory
Check adequacy of raw material specifications RU/SU
Ship reference substancesto RU
Specify qualification parameters (RU laboratory)
Execute parallel analysis at RU
Coach analytical methods at RU (optional)
Document results of Technology Transfer - QC
Train analytical methodsat SU
Specify scope of Technology Transfer –Production
Define Transfer Campaign Size
Check comparability of process equipment
Specify equivalency check
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 Laboratory Equipment (CLLE)
Checklist Raw Material Specifications (CLRMS)
Checklist Shipping (CLS)
Laboratory Qualification Report –Part 1 (TTLQ-P1)
Qualify CP
Techn. Transfer Protocol –Production (TTPP)
Execute Regulatory Activities
Checklist Process Equipment
Equivalency Report –Part 1 (TTEQ-P1)
Training Certificates(CETP)
Training Certificates(CETQC)
Laboratory Qualification Report –Part 2 (TTLQ-P2)
Technology TransferReport –QC (TTRQC)
Equivalency Report –Part 2 (TTEQ-P2)
Techn. Transfer Report–Production (TTRP)
Product Transfer Master Report’ (PTMR)
End
Remarks: CP –Chemical Product; 1) for more details please see Handbook
Production TransferQC Transfer
44
GATE 4
GATE 3
GATE 2
GATE 1
North to Phase V Product Transfers: Project Phases / Responsibilities
45
GATE 8
GATE 7
GATE 6
GATE 5
North to Phase V Product Transfers: Project Phases / Responsibilities
46
GATE 9
North to Phase V Product Transfers: Project Phases / Responsibilities
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3) Technology transfer deliverables
Handbook for Transfers of Chemical Products V0248/102 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 Application
Establish 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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