Technology Transfer B.Pharmacy 7th Semester 2023 (2022-2023) Previous Year's Question Papers/Notes Download - HK Technical PGIMS

Explain about technology transfer.
Introduction:
• Transfer of technology is defined as a “logical procedure that controls the
transfer of any process together with its documentation and professional
expertise between developments or manufacturing sites.”
• Technology transfer is both integral and critical to the drug discovery and
development process for new medical products.
• It is a systematic procedure that is followed in order to pass the documented
knowledge and experience gained during development and or
commercialization.

 Fig-Different stages of technology transfer
Terminologies used in technology Transfer:
Quality risk Management (QRM):
Quality risk management is a systematic process for the assessment, control,
communication and review of risks to the quality of the pharmaceutical product
throughout the product life-cycle.
Receiving unit (RU):
An organisation where a designed product, process or method is expected to be
transferred.
Sending unit (SU):
An organisation from where a designed product, process or method is expected
to be transferred.
Standard operating procedure (SOP):
SOP is a written instruction that is documented for routine and repetitive activity.
Technology transfer report:
A documented summary of a specific technology transfer project listing
procedures, acceptance criteria, results achieved and conclusions.
Example of Technology Transfer in the Pharmaceutical Industry:
*Let's consider the development and technology transfer of a new tablet
formulation of a common pain reliever, "Pain-X."*
1. Development Phase:
• Source Unit: Research and development (R&D) department within a
pharmaceutical company.
• Receiving Unit: A manufacturing facility in a different location or a
CMO.
• Knowledge Transfer: The R&D team develops the formulation for PainX, along with detailed process specifications and analytical methods for
quality control. They also conduct stability studies to determine the
product's shelf-life.
• Documentation and Records: SOPs for formulation, process, and quality
control are created. Batch records for pilot-scale batches are prepared, and
the analytical methods are validated.
2. Transfer Phase:
• Knowledge Transfer: The R&D team and the manufacturing team hold
regular meetings to transfer the knowledge and address any questions or
concerns. This may involve training sessions and exchange of technical
documents.
• Documentation and Records: All documentation, including batch
records, validation reports, and SOPs, is transferred to the manufacturing
unit.
• Quality and Regulatory Compliance: The manufacturing unit ensures
that it follows the procedures according to the documentation to maintain
quality and regulatory compliance.
3. Scale-Up and Validation Phase:
• Receiving Unit: The manufacturing unit scales up production to
commercial levels, using the transferred knowledge and documentation.
• Quality and Regulatory Compliance: Validation studies, including
process validation and analytical method validation, are conducted to
demonstrate the product's consistency and compliance with regulatory
standards.
4. Commercial Production Phase:
• Receiving Unit: The manufacturing unit commences commercial
production of Pain-X.
• Quality and Regulatory Compliance: Continuous monitoring and
quality control ensure that the product meets the required quality and
regulatory standards.