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

3

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.


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.


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*





Pony Mixer / Blend CubeAdd P1 and P2

– Mix for 10 min

Pony Mixer / Blend CubeAdd Mag Stearate

– Mix for 5 min



• These processes have the same SUPAC classification per CDER• This product transfer will be filed as a CBE – 30

Study*


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


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


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


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


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


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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.


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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


Gate 5. QC Documents Completed

Specify ...






Establish PTMP

QC Documentation must be set prior to process transfer

Quality ControlDocs complete


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


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


Gate 6. Expansion Documents Completed

Specify ...






Prepare Technology Transfer Docs

Establish PTMP



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


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30

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 ...






PrepareTechnology Transfer Docs

Establish PTMP

Execute Regulatory Activities


Execute Expansion Document ...

• results of technology transfer

• results of qualification and regulatory activities


Product Transfer Master Report’ (PTMR)


Gate 8. Validation / Stability

1) Never fail validation / stability batches.

Highest variation


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


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


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


46

GATE 9


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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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