Presentation Overview

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

1.0 Introduction - Robert Beall

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

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) .
20072010 BIPKG International transfer between Germany and India for WW distribution.
20102011 BVL Life-Cycle product transfer of parenteral manufacturing to new facility.

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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

Performance

Process Go-Live

Technology
Transfer

Secondary
Development
(fixing issues)

Time

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.

2. The Concept of Vertical Take-Off

Performance

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).

2. The Value of Vertical Take-Off

Performance

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).

3) Process transfers vs. Technology transfers

Process 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 Transfers

A) Process Transfer examples

B) Technology Transfer examples

Bi-Layer tablet compression for FDC

DPI encapsulation
Gamma radiation sterilization for parenteral
products

API manufacturing technology

NDA Product manufacturing
ANDA Product transfer

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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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 5
weekends
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
Prepare Technology Transfer
Technology Transfer Protocol Quality Control
Laboratory Qualification Report - Part 1 (TTLQ-Part1)
Checklist 'Laboratory Equipment (CLLE)
Checklist 'Raw Material Specifications (CLRMS)

One
Process Step

All
Process Steps

() 1)

Checklist 'Shipping (CLS)

Technology Transfer Protocol Production (TTPP)

Equivalency Report Part 1 (TTEQ-Part1)

Checklist Process Equipment (CLPE)

() 1)

Execute Technology Transfer

Technology Transfer Report Quality Control

Laboratory Qualification Report - Part 2 (TTLQ-Part2)

Technology Transfer Report Production (TTRP)

Equivalency Report Part 2 (TTEQ-Part2)

() 1)
() 1)

5) Application Techniques for Technology Transfers

9 Gate Technology Transfer Approach
Project
Opportunity

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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5) Application Techniques for Technology Transfers

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

Gate 1. Project Recommendation -Scope of Transfer Process
The Master Documentation provides the framework for the transfer process. The Product Transfer Master Plan (PTMP) scope
document defines the boundaries of the transfer.

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

5) Application Techniques for Technology Transfers

Gate 1. Gate 1. Project Recommendation Know what you are
transferring.
Sending Site Process

Receiving Site Process

P1 Stokes Mixer

P2 Stokes Mixer

P1 Stokes Mixer

P2 Stokes Mixer

Add MCC, API, Dextrose

Add MCC, API, Dextrose

Add MCC, API, Dextrose

Add MCC, API, Dextrose

and Starch, Mix for 5 min

and Starch, Mix for 5 min

and Starch, Mix for 5 min

and Starch, Mix for 5 min

Pony Mixer

Pony Mixer / Blend Cube

Add P1 and P2

Add P1 and P2

Mix for 10 min

Mix for 10 min

Pony Mixer
Add Mag Stearate

Pony Mixer / Blend Cube

Study*

Add Mag Stearate

Mix for 5 min

Mix for 5 min

Poly Lined Drum

SS Bin

Transfer Blend through #10 screen

Transfer Blend through

#10 screen

Manesty Press
Compress 25 mg tablets

Killian Press

Study*

Compress 10 mg tablets

These processes have the same SUPAC classification per CDER

This product transfer will be filed as a CBE 30

5) Application Techniques for Technology Transfers

Gate 1. Project Recommendation Know what you are transferring
vs. Company Metrics
Product Design Attribute (PDA) TABLES
Comment

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

2 blister (7-ct push + 10-ct peelpush)

2 bottles 60mL + 120mL
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.

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+

5) Application Techniques for Technology Transfers

Gate 2. Project Go
In order to support the documentation of the decision to execute technical
transfer the Decision' template specifies format and content.
Technology Transfer

Template

eRoom Folder:
1 Transfer Management

18/102
Handbook for Transfers of Chemical Products V02

January 17, 2007

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

Set up transfer project

PL

yes

Set-up Transfer

Set up eRoom

PL

yes

Set-up Transfer

Denominate transfer team

PL

yes

Set-up Transfer

Prepare kick-off meeting

PL

yes

Preparation of TTP

Idemtification of documents

PM RU

yes

Preparation of TTP

Preparation of documents

PM SU

yes

Preparation of TTP

Preparation of TTP - Quality Control

QC SU

yes

Preparation of TTP

Acquisition and evaluation of the existing documentation on the synthetic

method, including eventual batch records

P SU

yes

Preparation of TTP

Acquisition and evaluation of general documentation about ritical

parameters or of a complete development report

P SU

yes

Preparation of TTP

Check production needs and their compatibility with the actual planning

P SU

yes

Preparation of TTP

Feasibility analysis in plant on the existing documentation and lay-out

hypothesis of the process

P RU

Preparation of TTP

Cost analysis on production hypothesis

Preparation of TTP

Acquisition and evaluation of the safety documentation of the process,

including MSDS

PM RU
P RU

Example

eRoom
Folder:
yes
1yesTransfer Management
yes

5) Application Techniques for Technology Transfers

Gate 3. Project Plan
In order to specify the product transfer, the Product Transfer Master Plan (PTMP)
template provides predefined structure, format and content.

Template

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

Conduct the
Pre-Use Flush
for the Closed
Solvent
Transfer
System

Gate 4. Process Flow

1)
2)

3)
4)
5)
6)
7)
8)

Map production process with SME / Operators

Identify Critical Process Parameters (CPP) and Critical
Quality Attributes (CQA) as they relate to finished
product
Confirm all CPP / CQA have studies to support
acceptance ranges.
Conduct studies to confirm CPP / CQA ranges to fill
gaps
Determine best practice / gold standard process
Create CPP / CQA database (PANDA)
Compare CPP / CQA data values to gold standard
and ranges to determine cause of variance.
Provide real time data trending to operators to enable
educated process adjustment.

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.

Continue agitation throughout solvent transfer

Target transfer
weight of the
vessel achieved

Remove inlet
hose and Valve
No.2 from the
vessel and
record weight.

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5) Application Techniques for Technology Transfers

Gate 4. CPP / CQA Matrix
Formulation

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

Based on ICH Q9 Guidelines

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5) Application Techniques for Technology Transfers

Gate 5. QC Documents Completed
QC Documentation must be set prior to process transfer

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

5) Application Techniques for Technology Transfers

Gate 5. QC Documents Completed
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).
Production

Product
Receiving Unit

1st step:
Qualification of laboratory

2nd step:
Equivalency check of
product

(Parallel analysis of reference

substance by SU and RU)

(Comparison of transfer batches

with reference batches)
Production Transfer

Product
Sending Unit

Quality Control
Transfer

Test
Sending Unit

Quality Control

Test
Receiving Unit

5) Application Techniques for Technology Transfers

Gate 5. QC Documents Completed
The 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
Example
fulfillment of the acceptance criteria.

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)

Quality Control
Docs complete

Prepare
Technology Transfer Docs

Establish PTMP

5) Application Techniques for Technology Transfers

Gate 6. Expansion Documents Completed
The technology related part of the transfer is documented in technology transfer
documentation.
Technology Transfer Quality Control
Technology Transfer - Production
1)
Prepare
Specify scope of QC Transfer

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)
3)
Train analytical methods at SU Execute

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)

4)
Prepare
Specify scope of Production Transfer
Define Transfer Campaign Size

TT Protocol Production (TTPP)

Check equivalence of process

CL Process Equipment (CLPE)
5)
Specify equivalency check

TT Equivalency QualificationPart 1 (TTEQ-P1)

Execute
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)

January 17, 2007

5) Application Techniques for Technology Transfers

Gate 6. Expansion Equivalency Check
Knowledge
Range
Proven
Acceptable Range
Normal
Operating Range

Parameter
Scale

Target Value

5) Application Techniques for Technology Transfers

Gate 6. Expansion Equivalency Check
The equivalency check has to be conducted for non critical parameters by min/max
EXAMPLE
comparison.
1) have to be used to demonstrate equivalency.
For
critical parameters
QC Upper
ChartsSpecification
Production RU
Production
SU
Limit (USL)

+ 3 3)

Lower Tolerance Limit (LTL) 2)

Specification

Measured
Value

Upper Tolerance Limit (UTL) 2)

Sample
No

Lower Specification Limit (LSL)

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
30
false decision is 0,3%

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30/102

5) Application Techniques for Technology Transfers

Gate 7. Expansion Completed

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)

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 @ 25C/60% r.H.
101.0

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

5) Application Techniques for Technology Transfers

Gate 9 Post Approval Assessment / Post Mortem
1.
2.
3.
4.

Review deliverables vs. plan

Review budget vs. plan
Review timeline vs. Base Plan
Revise templates accordingly.

6) Technology transfer skill sets

Management, Safety, QA, QC, Finance, Change Management, Engineering, Micro, Validations,
Operations, Customer, Contract Management, DRA

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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

Conclusion
In Compliance
+
On Schedule
+
In Budget
=
SUCCESS !
ProPharma Group is the Best Choice
to balance all three needs!

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Product Design Attribute (PDA) TABLES

Comment

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

2 blister (7-ct push + 10-ct peelpush)

2 bottles 60mL + 120mL
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.

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

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Only single supplier available but

other suppliers can be developed.
Bottle: Gaplast

Single source supply with

patent restrictions against
alternate suppliers.

2+

5+

39

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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 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.

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Appendix A B CD
9 Technology Transfer
Document Flow
Appendix

9 Technology Transfer Document Flow1)

IChC Decision (FID)

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

Specify scope of Technology

Transfer Production

Techn. Transfer Protocol

Production (TTPP)

Check equivalency
of laboratory

Checklist Raw Material

Specifications (CLRMS)

Check adequacy of raw

material specifications RU/SU

Checklist
Shipping (CLS)

Ship reference substances

to RU

Laboratory Qualification
Report Part 1 (TTLQ-P1)

Specify qualification
parameters (RU laboratory)

Training Certificates
(CETQC)

Define Transfer Campaign

Size

Check comparability of
process equipment

Checklist Process
Equipment

Specify equivalency
check

Equivalency Report
Part 1 (TTEQ-P1)

Train analytical methods

at SU
Train manufacturing
process at SU

Coach analytical methods at

RU (optional)
Laboratory Qualification
Report Part 2 (TTLQ-P2)

Execute parallel analysis

at RU

Technology Transfer
Report QC (TTRQC)

Document results of
Technology Transfer - QC

Training Certificates
(CETP)
Coach manufacturing
process at RU

Produce transfer campaign

at RU

Execute equivalency check

Equivalency Report
Part 2 (TTEQ-P2)

Document results of Techn.

Transfer - Production

Techn. Transfer Report

Production (TTRP)

Qualify CP

Execute Regulatory Activities

Product Transfer
Master Report (PTMR)

Document transfer of CP
End

Remarks: CP Chemical Product; 1) for more details please see Handbook

Handbook for Transfer of Chemical Products

Jan 17, 2008

North to Phase V Product Transfers:

Project Phases / Responsibilities

GATE 1

GATE 2
GATE 3
GATE 4

44

North to Phase V Product Transfers:

Project Phases / Responsibilities

GATE 5
GATE 6

GATE 7
GATE 8

45

North to Phase V Product Transfers:

Project Phases / Responsibilities

GATE 9

46

3) Technology transfer deliverables

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Scope of Transfer Process (1)

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.
Release as additional Manufacturer (End)

Tech Transfer

CRC
Application

conceptual

Establish Product Transfer Master

Report
Execute regulatory activities ...
Qualify API (by MP)

Execute Technology Transfer Production

Equivalency of API

MP Approval

Execute Technology Transfer QC Laboratory Qualification 1)

Prepare Technology Transfer Production
Prepare Technology Transfer QC
Establish Product Transfer Master Plan
Manage project
IChC decision (Start)

...
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

Confidential

49