TECHNOLOGY TRANSFER PROCESS IN PHARMACEUTICAL INDUSTRY: AN OVERVIEW

 

Technology Transfer Team:
The technology transfer team consists of the following members and their responsibilities are given below:

Table 1: constitution of technology transfer team and their responsibilities

Technology Transfer Team Member

Responsibilities

Process Technologist

a.       Central focus for transfer activities.

b.      Collates documentation from donor site

c.       Performs initial assessment of transferred project for Feasibility, Compatibility with site capabilities and Establishes resource requirements.

 

Technology Transfer Team Member

Responsibilities

QA Representative

a.       Reviews documentation to determine compliance with marketing authorization (MA).

b.      Reviews analytical methods with QC to determine capability, equipment training requirements.

c.       Initiates conversion of donor site documentation into local systems or format.

d.      Initiates or confirms regulatory requirements, e.g., change to manufacturing license; variations to MA if process changes needed, etc.

Production Representative

a.       Reviews process instructions (with process technologist) to confirm capacity and capability.

b.      Considers any safety implications, e.g., solvents; toxic; sanitizing materials.

c.       Considers impact on local standard operating procedures (SOPs).

d.      Considers training requirements of supervisors or operators.

Engineering Representative

a.       Reviews (with production representative) equipment requirement.

b.      Initiates required engineering modifications, change or part purchase.

c.       Reviews preventative maintenance and calibration impact, e.g., use of more aggressive ingredients; more temperature sensitive process, and modifies accordingly.

QC Representative

a.       Reviews analytical requirement.

b.      Availability with instruments.

c.       Responsible for analytical method transfer for drug substance and drug product.

Technology Transfer Checklist:
A checklist that summarizes the details that should be collated during the process, the majority of which have already been referenced.
Copy of Part 2 of marketing authorization, Production master formula, Manufacturing instructions, Dispensing instructions, Analytical methods, Previous process validation, Previous analytical validation, Cleaning instructions and previous cleaning validation, Stability reports, Excipient specifications and source, Active specifications and source, Primary packaging material specifications and source, Packaging instructions, Customer complaints, Process deviations file, Analytical deviations file, Reject and rework file, Specimen manufacturing batch record, Specimen cartons, labels, leaflets.

Factors affecting the Success of Technology Transfer:
*  Unlike the greenfield R & D project, the technology transfer is the importation of a developed R & D product from outside the company. Therefore, a complete background of technology with it’s possible strengths & weaknesses need to be understood in the beginning.
*   Issues related to costs, royalty, royalty payment, milestone payments need to be considered before the technology transfer is to be opted. If this due diligence is not done correctly, the project may loose it’s priority within the company.
*  Regulatory issues including ‘difficult to ressolve’ issues need to be correctly addressed while the project is on.
*  Accurate calculations of time-lines with enough margins for development/ scale-up related issues, country of licencing, regulatory guidelines existing in the country of origin, need to be taken into account.
*  Lastly, the major factor is a team which accepts the technology & the team that offers the technology should have complete understanding of the entire project & needs to develop a personal raport besides official project structure.

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