On December 10, 2021, the Recommendation of the Board of the Eurasian Economic Commission dated June 8, 2021 No. 11 “On the Guidelines for the Transfer of Technologies and (or) Analytical Methods in the Production of Medicines” comes into force.
The Guidelines contains instructions for drug manufacturers, testing laboratories, pharmaceutical inspectorates and expert organizations of the EAEU member states regarding the actions necessary to carry out a successful transfer of technologies and (or) analytical methods between structural units within one production site, or several production sites, or testing laboratories.
The purpose of technology transfer is to transfer information about a medicinal product, its production process and quality control within one production place or between production places, including when transferring a pharmaceutical development to production, as well as transfer of analytical methods from the production site to an accredited testing laboratory.
The transfer involves the transfer of any process, together with the relevant documentation and professional expertise, from the transferring party to the receiving party. It is a systematic procedure that is performed with the aim of transferring documented information and experience gained during pharmaceutical development to the receiving party.
The Guidelines introduces the following main technology transfer stages:
- planning, organization, management;
- determination of the criteria for the success of the transfer;
- formation of a group (team) of the project;
- consolidation of knowledge, analysis of discrepancies;
- identification of key skills and training of personnel (if necessary);
- analysis and risk assessment;
- development of the transfer protocol;
- qualification of production facilities, equipment, engineering systems (if necessary);
- transfer of analytical methods as part of technology transfer or as an independent process (if necessary);
- production of pilot industrial (pilot) and (or) engineering series;
- process validation;
- cleaning validation;
- registration of results and evaluation of the transfer efficiency based on the achievement of the established success criteria.
Not all of the indicated transfer stages are applicable to every type of transfer. Manufacturers can choose the steps that are applicable to the procedure being carried out.
The main participants in the transfer are the sending and receiving parties. If necessary, a coordinating party is additionally determined, which can be an independent person (process administrator). With regard to the transfer of production under a contract, it is necessary to follow the Rules of Good Manufacturing Practice.
For a successful technology transfer, the following requirements must be met:
- during the transfer, all aspects of quality in relation to the production of medicines should be controlled;
- transfer should be based on quality risk management principles;
- capabilities of the transmitting and receiving parties should be similar, but not necessarily identical, and the premises and equipment should be operated in accordance with the same operating principles;
- comprehensive analysis of discrepancies between the transmitting and receiving parties should include an assessment of technical risks and potential discrepancies with the requirements of regulatory documents;
- personnel of the receiving party must be properly trained, qualified, trained at the site of the transmitting and (or) receiving party, in accordance with the transfer plan;
- during the entire transfer procedure, it is necessary to take into account and uniformly interpret the regulatory requirements of the authorized bodies of the states in which the transmitting and receiving parties are located, as well as the authorized bodies of third countries to which the drug is planned to be supplied;
- effective transfer of processes, skills and knowledge about the drug should be carried out.
The Guidelines also contain such forms of documents as the protocol for the transfer of technologies and the protocol for the transfer of analytical methods, as well as the forms for the transfer reports.
The EAEU members are recommended to apply the Guidelines after 6 months from the date of its publication (published on the official website of the EAEU on June 10, 2021).
July 11, 2021