Abstract
Introduction. In the process of pharmaceutical development of a medicinal product, it is necessary to substantiate the composition of the medicinal product; develop a technology for a finished dosage form (including a primary packaging system); create documentation for various stages of product development; validate analytical methods and technological processes. Information obtained in the course of experimental research and development of a medicinal product is included in the registration dossier. Documenting a pharmaceutical development allows you to systematize knowledge about monitoring technological processes, product quality indicators, and present the integrity of the data obtained.Aim. Creation of documentation for pharmaceutical development within the pharmaceutical quality system of the enterprise.Materials and methods. In the course of the research, the following methods were used: content analysis; system analysis; systems approach.Results and discussion. On the pharmaceutical development of two-component suppositories within the FGC, based on the knowledge gained about the process and the product and taking into account the risk analysis, we have created documents that were adapted to the enterprise's document flow to optimize the documentation process at the subsequent stages of the drug's life cycle. For optimal documentation of the first stage of drug development, a list of documents is proposed, including: Report on the pharmaceutical development of two-component suppositories; specifications for raw materials and materials, intermediate products, finished products; standard operating procedures during the pharmaceutical development phase; Guidelines for monitoring processes and product quality; Instructions for corrective and preventive actions (CAPA), change management, management review; report on the analysis of the effectiveness of the quality assurance system in the pharmaceutical development of two-component suppositories. The proposed set of documents makes it possible to form a single base of knowledge and results obtained at this stage, to systematize and structure them.Conclusion. In the course of the pharmaceutical development of two-component suppositories, knowledge has been generated about the process of creating a product of proper quality. A set of documents has been developed, consisting of reports, specifications, standard operating procedures, instructions, for an enterprise planning to produce two-component suppositories. Pharmaceutical development documentation is adapted to the enterprise document flow to optimize the documenting process at the subsequent stages of the drug product life cycle.
Highlights
In the process of pharmaceutical development of a medicinal product, it is necessary to substantiate the composition of the medicinal product; develop a technology for a finished dosage form; create documentation for various stages of product development; validate analytical methods and technological processes
On the pharmaceutical development of two-component suppositories within the FGC, based on the knowledge gained about the process and the product and taking into account the risk analysis, we have created documents that were adapted to the enterprise's document flow to optimize the documentation process at the subsequent stages of the drug's life cycle
Pharmaceutical development documentation is adapted to the enterprise document flow to optimize the documenting process at the subsequent stages of the drug product life cycle
Summary
В качестве модели для документирования нами было выбрано предприятие, планирующее выпуск двухкомпонентных ректальных суппозиториев. Системный анализ служил основой для логического и последовательного подхода к решению поставленных задач исследования. Системный подход применялся при создании документации на суппозитории в рамках ФСК. На этапе фармацевтической разработки ЛП для достижения поставленной цели в области качества следует реализовывать соответствующие элементы ФСК (таблица 1). При последовательной реализации элементов ФСК создается продукт с надлежащим качеством, который соответствует потребностям пациентов и отвечает требованиям регуляторных органов. Руководство ICH Q10 «Фармацевтическая система качества» для структурирования системы документации предлагает использовать процессный подход, который предполагает включение документа, описывающего конкретный процесс, в определенный уровень документации [7]. Классификация документов по уровням при фармацевтической разработке ЛП представлена в таблице 2. По структуре и содержанию документов можно судить о деятельности организации в целом, о корпоративной культуре качества, о процессе управления знаниями, а также фактическом соблюдении персоналом принципов надлежащих практик
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