What is technology Transfer
Technology transfers is the transferring of knowledge, systems, processes, and products from one site or organization to another. It is a legal and systematic approach that defines the role of each site in the entire product life cycle, supported by relevant documentation, regulatory approvals, and necessary facilities.
Technology transfer can occur between different types of pharma business operators until they follow the required processes and relevant regulatory regulations.
Sending Unit and Receiving Unit
There are two main entities during the technology transfer process in pharma industry, irrespective of the business operations type – Sending Unit and Receiving Unit
The sending unit transfers the intended process, product, or development to the Receiving Unit . The sending unit is primarily responsible for developing and transferring all the relevant necessities, such as documentation, technology, training, and manufacturing processes.
The receiving Unit is the entity where the sending Unit transfers the desired product or technology. The receiving Unit must be able to perform all parts of the transferred technology or process independently, within quality and/or regulatory regulation limits.
The sending and receiving Unit can be under the same organizations or be under different organizations. Within the same organization, the technology transfer occurs between its R&D and manufacturing site.
Whereas under different organizations, technology transfer occurs between the R&D lab and Contract Manufacturers for commercial-scale production
What is included in the technology transfer?
Technology transfer in the pharma industry is a comprehensive activity that involves carefully selecting all components of the entire product cycle. If not chosen critically, the technology transfer process could fail and/or face regulatory fines.
Some steps involved in a typical technology transfer include, but are not limited to
Planning
Planning is the critical stage of technology transfer that defines the transfer's goals, and what route it will take during the entire technology transfer.
In this stage, decisions such as
· What involves the technology transfer, i.e., manufacturing, packaging, or analytical methods
· Need for technology transfer
· Target market
· Responsibilities of the Sender Unit and Receiving Unit
· Expectation from the receiving unit
Any other areas that justify the need for technology transfer are included, and forms the basis of the entire transfer process
Capabilities Assessment
In this step, the capabilities of the receiving Unit are assessed. It is determined whether it can fulfill all requirements and manufacture products as per the sending unit recommendation and quality standards. The assessment is carried out regarding all aspects of pharma manufacturing stages.
The main aim of the assessment is to highlight any issues before the technology is transferred and resolve them to prevent problems and faults in the product.
For example,
· The sending unit assesses the RU regarding equipment and suggests improvement, such as overhauling of equipment or adding a new one.
· Evaluating the RU's capability to handle, quality issues and how they can resolved.
After the assessment is complete, the team submits its recommendations, which form the basis of whether the RU can handle the technology transfer.
Analytical Assessments transfer
Analytical assessment include the analytical function involved in the pharma process. It focuses on implementing analytical strategies, and it intends to fulfill the analytical requirements,
The sending unit must transfer all the analytical methods and relevant information to the receiving unit. The SU is also responsible for providing training, assisting in testing, defining all product-specific testing procedures, sampling methods, acceptance criteria, validation reports and equipment details...
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