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Technology Transfer From R&D To Production
Technology Transfer From R&D To Production
Technology Transfer From R&D To Production
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INTRODUCTION
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.
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Objectives of Technology Transfer
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
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Reasons for technology transfer
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.
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Technology transfer from various sectors
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Technology transfer process flow chart
Promotion
Commerci
Innovation
alization
Investment R&D
Information
And
Assessment
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Technology Transfer Team
The technology transfer team consists of :
Process Technologist
QA Representative
Production Representative
Engineering representative
QC Representative
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Roles of Technology Transfer Team
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 Reviews process instructions (with process technologist) to verify capacity 8
Roles of Technology Transfer Team
Role Responsibility
4. Engineering Reviews (with production representatives) instrumentation
Representative 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.
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Technology transfer from R&D to Production
(Development Phase)
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.
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Technology transfer from R&D to Production
(Development Phase)
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.
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Success of Technology Transfer
It depends on :
Communication :
Open communication between all team members
Effective and timely communication with regulators
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Checklist for technology transfer
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
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Conclusion
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.
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