Проведена валидация технологического процесса препарата «Глюконил®, таблетки, покрытые оболочкой, 1000 мг». Для каждой критической стадии процесса определены оптимальные параметры технологического процесса, установлен перечень контролируемых показателей качества, влияющих на безопасность и эффективность лекарственного препарата, и критерии их приемлемости, разработана рациональная схема отбора образцов, обеспечивающая их репрезентативность. Результаты, полученные при производстве трех промышленных валидационных серий, доказывают постоянство и надежность процесса производства лекарственного препарата от серии к серии и для каждой единицы дозированной лекарственной формы. The technological process of the preparation «Gluconil®, coated tablets, 1000 mg» was validated. For each critical stage of the process, the optimal parameters of the technological process are determined, a list of controlled quality indicators affecting the safety and efficacy of the medicinal product, and the criteria for their acceptability are established, a rational scheme for sampling is developed, ensuring their representativeness. The results obtained in the production of three industrial validation batches prove the consistency and reliability of the production process of the medicinal product from batch to batch and for each unit of the dosage form.
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