Technology transfer in a pharmaceutical enterprise is the process of transferring production technologies developed in a laboratory to a production unit. The purpose of technology transfer is to ensure the same level of product quality at all stages of its production.
In accordance with the current requirements of the EAEU, the purpose of transfer of technologies and (or) analytical methods is the transfer of information about a medicinal product, the process of its production and control within one production site or between production sites, including when transferring a pharmaceutical development to production, in order to achieve the purpose of production of industrial batches of the medicinal product, as well as the transfer of analytical methods from the production site to an accredited testing laboratory.
Transfer involves the transfer of any process, along with its documentation and professional expertise, from the transferring party to the receiving party.
Transfer is a systematic procedure that is carried out in order to transfer to the receiving party the documented information and experience gained during the pharmaceutical development and (or) release of medicines into circulation.
Organization, management and planning
Definition of success criteria
Formation of a group (team) of the project
Consolidation of knowledge, analysis of discrepancies
Identification of key skills and training of personnel (if necessary)
Conducting risk analysis and assessment
Development of a transfer protocol
Qualification of industrial premises, equipment, engineering systems (if necessary)
Transfer of analytical methods (if necessary as part of technology transfer or as an independent process)
Production of pilot (pilot) and (or) engineering series
Process validation, cleaning validation
Documenting the results and evaluating the effectiveness of the transfer to achieve the established success criteria
Transfer requires a documented, planned approach using trained and qualified personnel working within a quality system, with documented data covering all aspects of drug development, production and quality control. When carrying out the transfer, the principles of data integrity must be observed.
Transfer projects (for example, projects between different companies) have legal and economic implications. In the event that issues that may include intellectual property rights, copyrights, pricing, conflicts of interest and confidentiality will in any way affect the open nature of the communication of technical information, then these issues should be considered before and during planning and implementation of the transfer.