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Organization and support of analytical transfers
Analytical transfer
Analytical transfer in a pharmaceutical enterprise is the process of transferring methods of analysis developed in a laboratory to a manufacturing unit. The purpose of analytical transfer is to ensure the same level of product quality at all stages of its production.
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Technology transfer
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.
It is important to note
Analytical and technological transfer in a pharmaceutical enterprise must be carried out in accordance with the requirements of regulatory authorities and quality standards. This ensures that the products are safe and effective for patients.
Transfer target
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.
What does the transfer include?
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.
The transfer covers the transfer of documentation, production processes, skills and knowledge from the transferring party and practical confirmation of the ability of the receiving party to effectively perform the critical operations of the transferred technology in order to ensure the traceability of this process for all interested parties and authorized bodies (expert organizations).
Process
The main stages of the transfer:
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Organization, management and planning
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Definition of success criteria
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Formation of a group (team) of the project
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Consolidation of knowledge, analysis of discrepancies
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Identification of key skills and training of personnel (if necessary)
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Conducting risk analysis and assessment
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Development of a transfer protocol
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Qualification of industrial premises, equipment, engineering systems (if necessary)
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Transfer of analytical methods (if necessary as part of technology transfer or as an independent process)
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Production of pilot (pilot) and (or) engineering series
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Process validation, cleaning validation
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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.
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Registration
Development of registration dossier, registration, licensing and certification
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Clinical and preclinical studies
Organization and support of preclinical and clinical studies
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OLFARM LLC is an independent accredited laboratory and research center. The scope of accreditation of the testing laboratory includes a wide range of physicochemical, microbiological, virological and biological methods.
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