Technology transfer from R&D to production

Rutuja Dattatray Chougale,
Research Scholar,
M. Pharm Semester I,
Tatyasaheb Kore College of Pharmacy, Warananagar.
1

 Technology transfer is transferring of details of concerning
formulation and analytical strategies from one area to another area
that’s from R&D to Production department and succeeding drug
product from the laboratory scale to the production scale.
 Technology transfer is the process by which a developer of
technology makes its technology available to a commercial partner
that will exploit the technology.
 In pharmaceutical industry, “Technology transfer” refers to the
process of successful progress from drug discovery to product
development, clinical trials and ultimately full-scale
commercialization.
2

 To explain the processing information to transfer technology
from R&D to production site by listing out information
gathered during R&D.
 To explain the processing information to transfer technology
of already existing drug product between various places.
 To illustrate specific procedures and points to be considered
for the above two types of technology transfer to contribute
smooth technology transfer.
3

 Due to lack of manufacturing capacity.
 Due to lack of resources to launch product commercially.
 Due to lack of marketing distribution and distribution
capability
 Forming alliance with partners
 Exploitation in a different field of application
 List of institutes assisting technology transfer-
Asia Pacific Centre for Transfer of Technology (APCTT)
Technology Bureau for small enterprise (TBSE)
National research and development co-operation.
4

Promotion
Innovation
R&D
Information
And
Assessment
Investment
Commerci
alization
6

The technology transfer team consists of :
 Process Technologist
 QA Representative
 Production Representative
 Engineering representative
 QC Representative
7

Role Responsibilities
1. Process Technologists Central focus for transfer activities.
Collates documentation from the donor site.
Performs initial assessment of the transferred project for feasibility,
compatibility with site capabilities and establishes resource needs.
2. QA Representative Reviews documentation to work out compliance with marketing
authorization.
Reviews analytical strategies with QC to work out capabilities,
instrumentation training requirements.
Initiates conversion of donor site documentation into local systems or
format.
Initiates or confirms regulatory needs, e.g., an amendment to
manufacturing license; variations to marketing authorization if method
change needed, etc.
3. Production
Representative
Reviews process instructions (with process technologist) to verify capacity
and capability.
Consider any safety implications e.g., solvents, toxicity, sanitizing
material.
Considers the training requirements of supervisors or operators.
8

Role Responsibility
4. Engineering
Representative
Reviews (with production representatives) instrumentation
requirement.
Initiates required engineering modifications, change or part
purchase.
Reviews preventative maintenance and calibration impact, e.g., use
of a lot of aggressive ingredients; more temperature-sensitivity
method, and modifies consequently.
5. QC Representative Reviews analytical requirement
Availability with instruments
Responsible for analytical technique transfer for drug substance and
drug product.
9

Development of technology by R&D (Research phase)
Technology transfer from R&D to production
Optimization and production (Production phase)
Technology transfer documentation
10

R&D provides technology transfer dossier (TTD)
document to a product development laboratory that contains
all data of formulation and drug product as given below :
1. Master Formula Card (MFC) – It includes product name along
with its strength, generic name, MFC number, page number,
effective date, shelf life, and market.
2. Master Packaging Card – It provides data regarding
packaging sort, the material used for packaging, stability
profile of packaging and shelf life of packaging.
11

3. Master Formula – It describes formulation order and
manufacturing instructions. Formulation order and
Manufacturing instructions offer the plan of process order,
surroundings conditions needed and manufacturing
instructions for the development of dosage form.
4. Specifications and Standard Test Procedures (STPs) – These
help to know active ingredients and excipients profile, in-
process parameters and specifications, product release
specifications and finished product.
12

It depends on :
 Communication :
 Open communication between all team members
 Effective and timely communication with regulators
 Sending and receiving unit
 Technology transfer is not a “one way street”
 The sending unit and receiving unit must be equally involved
in the process to ensure success
 Team work at all time
13

 Production master formula
 Manufacturing and Dispensing instructions
 Analytical methods
 Cleaning instructions and previous cleaning validation
 Active specifications and source
 Primary packaging material specifications and source
 Packaging instructions
 Process deviations file, Analytical deviation file
 Specimen manufacturing batch record
14

 Technology transfer creates a bridge between the R&D and
production as it helps in creating more efficient and safe
medications.
 The technology transfer does not mean one-time actions
taken by the transferring party toward the transferred party
however, suggest that continuous information exchange
between the parties to maintain the product manufacturing.
 Development, transfer, production and documentation are the
phases of technology transfer.
 There are certain checklist materials which are followed
during technology transfer.
15

Technology transfer from R&D to production

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