The document discusses the development and transfer of technology in pharmaceutical manufacturing, focusing on dosage forms such as tablets, capsules, and injections. It highlights the process of tablet development, from formulation to production, and emphasizes the importance of adherence to WHO guidelines for effective technology transfer, ensuring quality and compliance. A risk-based approach is recommended for successful knowledge transfer between development and manufacturing sites to maintain consistent medication quality.

1. Technology Development and Transfer
Dr Sunil Kanvinde
10 August 2023
privileged and confidential - Dr Sunil Kanvinde

2. Technology Development and Transfer
privileged and confidential - Dr Sunil Kanvinde
Index Slide
number
Dosage Forms 3 - 5
Development of Tablets 5 - 11
Transfer of Technology Concept 12 - 14
WHO Guidelines - Principles Transfer of Technology 17 - 24
Summary 25
Reference
World Health Organization WHO Technical Report Series, No. 961, 2011
Annex 7 WHO guidelines on transfer of technology in pharmaceutical
manufacturing

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Dosage Forms
Dosage forms (also called unit doses)
are pharmaceutical drug products
- in the form in which they are marketed for use,
- with a specific mixture of active ingredients (API) and
inactive components (excipients),
- in a particular configuration, and
- apportioned into a particular dose.

4. Dosage Forms and Uses
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Dosage forms (also called unit doses)
are pharmaceutical drug products
Example –
Each Tablet contains 500mg of Paracetamol.
Tablet weight is 800mg but it contains 500mg Paracetamol
Therefore 300 mg is excipient
Applicable to all similar units from same brand name from same manufacturer
in the form in which they are
marketed for use
Tablets, Capsules, Injections, Liquid
Orals, Eye drops
with a specific mixture of
active ingredients (API) and inactive
components (excipients),
Master formula in which API is mixed
with excipients like lactose, MCC, Talc,
Magnesium stearate for Tablets,
Capsules
in a particular configuration Quantities are defined in composition
apportioned into a particular dose Each unit has same configuration or
content of API and excipients

5. Dosage Forms
Dosage Forms Uses
Tablets Oral administration
Capsules Oral administration
Liquid – Syrup, Suspension Oral administration
Injection – Liquid, Dry Powder Parenteral route
Ointment External application
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6. Development of Tablets
Development is the first step where the Tablets are finalized
Appearance, Shape, Embossing, Color, Coating
Type of Tablets – Immediate release, SR, Chewable, Enteric coated etc
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7. Development of Tablets
Development is the first step where the Tablets are finalized
Appearance, Shape, Embossing, Color, Flavor
Trade Dress is commonly used term in Global context
Development is driven by
Content of active, active/ excipient ratio
Bench marking with innovator
QBD concept
Marketing expectations
Patient compliance
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8. Development of Tablets
Development experiments are small lots size experiments
In development laboratory using manual or semi automatic
machines
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9. Development of Tablets
Development experiments are small lots size experiments
In development laboratory using manual or semi automatic
machines
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10. Development of Tablets
Purpose of development is to achieve progressive end point of supply safe
and effective medication to patient with consistent quality
Outcome of various small experiments and testing
Selection of successful experiments by evaluation
Experiments with various processes
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Tablet mass preparation by
dry mixing
Tablet mass preparation by
dry mixing
Tablet mass preparation by
dry mixing and wet
granulation
Properties of powder Properties of granules Properties of granules
Content evaluation Content evaluation Content evaluation
Tablet preparation and
evaluation
Tablet preparation and
evaluation
Tablet preparation and
evaluation
Rating/ Evaluation for
further experiments

11. Development of Tablets
Purpose of development is to achieve progressive end point of
supply safe and effective medication to patient with consistent
quality
Outcome of various small experiments and testing
Selection of successful experiments by evaluation
Development knowledge is therefore important database for
future life cycle
It is a starting point of successful commercial product available
in market.
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12. Technology Transfer of Tablets - Connecting the DOTS
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Development of
Product
Manufacturing of
Product
Research and
Development
Large scale
manufacture
for
commerce

13. Technology Transfer of Tablets - Connecting the DOTS
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Development of
Product
Manufacturing of
Product
Research and
Development
Large scale
manufacture
for
commerce
How to connect small
experiments carried
out in Development
laboratory using small
equipment, manual
processes and end
points with large size
equipment, equipment
have auto controls and
where large batch size
is required due to
commercial needs

14. Technology Transfer of Tablets - Connecting the DOTS
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Development of
Product
Manufacturing of
Product
Research and
Development
Large scale
manufacture
for
commerce
Transfer the
process from R&D
Technology
Transfer

15. WHO guidelines - Principles
Transfer of technology is defined as “a logical procedure that
controls the transfer of any process together with its
documentation and professional expertise between
development and manufacture or between manufacture
sites”
“a systematic procedure that is followed in order to pass the
documented knowledge and experience gained during
development and or commercialization to an appropriate,
responsible and authorized party”
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16. WHO guidelines - Principles
Transfer of technology is from
Development lab to manufacturing site OR
One manufacturing site to other manufacturing site
It can happen during life cycle
Planned activity driven by documentation, GMP, Quality
system, skilled teams
Risk based approach is adopted
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17. WHO guidelines – Principles of Transfer of Technology
Principle explanation
The Transfer of
technology
project should
encompass the
quality aspects
of the project
Quality defined for Product based on process developed.
Quality – Physical parameters Appearance, Thickness, Friability, DT,
Dissolution
In process quality parameters - Bulk Density, Moisture content, Sieve
analysis
Process –
Mixing speed, Time, end point measurement
Drying – Temperature, Time
Compression parameters
Chemical test parameters assay, content uniformity, impurity, RS
Stability evaluation
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18. WHO guidelines – Principles of Transfer of Technology
Principle explanation
Transfer of technology should be based
upon the principles of quality risk
management
Mixing – mixing time is defied as 10 -15
min. During experimentation it is observed
that if mixing time is less than 10 min
uniformity is not obtained, granules are
not formed properly
Risk – Severity, Probability and
Detectability
If mixing time is more than 15 min
granules are hard and difficult
Equipment used for drying FBD/ Tray drier
Effect on granules, temperature Time
effect in two drying operations
Risk analysis of area used for mixing for
temperature, humidity
Risk analysis for light sensitive product
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19. WHO guidelines – Principles of Transfer of Technology
Principle explanation
facilities and equipment in SU and RU
should operate according to similar
operating principles
FBD vs Tray drier
SU – sending unit Milling equipment at two sites
RU – receiving unit Compression machines used for tablet
compression
Development facility has smaller machines
whereas manufacturing facilities have high
speed machines, similarity in operating
principles
Analytical equipment are also important
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20. WHO guidelines – Principles of Transfer of Technology
Principle explanation
a comprehensive technical gap analysis
between the SU and RU including technical
risk assessment and potential regulatory
gaps, should be performed as needed
In product transfer it is observed that
equipment is similar but required setting
parameters are not achievable
Roll compactor pressure setting, screen
size
Coating machine temperature setting
range
Process parameters need critical analysis
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21. WHO guidelines – Principles of Transfer of Technology
Principle explanation
adequately trained staff should be
available or should be trained at the RU
Knowledge transfer is important part of
Transfer of technology
SU documents are reviewed, evaluated for
any queries, more information need,
sample evaluation
Critical evaluation is possible only with
adequate training and experience
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22. WHO guidelines – Principles of Transfer of Technology
Principle explanation
RU should reproduce the documented
evidence of transferred product, process
or manufacturing method against the
predetermined specifications of SU.
VALIDATION Experimentation for the
product is very critical. Continuous
manufacturing is possible only is validation
is executed properly.
there should be effective process and
product knowledge transfer.
Clarity of transfer process
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23. WHO guidelines – Principles of Transfer of Technology
Principle explanation
Reporting of out of specifications results
and errors by the RU to SU.
Analysis of results is very important.
OOS results indicate process control and
product parameters control
Example – DT results variation during
compression stage
Cause analysis
Hardness values
Analytical OOS
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24. WHO guidelines –Transfer of Technology
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Scope –
Applies to API – Manufacturing and packaging
Applies to all dosage forms - Manufacturing and
packaging
Risk based approach – should be applied
GMP compliance during transfer
Documentation, Qualification, Validation, People
training

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Summary
Transfer of Technology is important intermediate step
connecting development and manufacturing site or one
manufacturing site with other
It is knowledge based approach supported by documentation
and Risk based evaluation of processes
People play important role in knowledge creation and sharing
Guidelines help to formulate Transfer of Technology process
by providing Principles and practices to define systems and
evaluation criteria