Микробиологические аспекты разработки и производства железосодержащих таблеток «Аферол»
Microbiological aspects of the development and manufacturing of Aferol iron-containing tablets
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The article presents the results of the analysis of microbiological risks during the development of the technology of non-sterile iron-containing tablets based on ferrous fumarate (drug «Aferol»). During the process development, critical points were identified, practical numerical guidelines for residual moisture and bioburden were established, microbiological control of excipients and finished product was performed, and measures to ensure microbiological purity in accordance with GMP requirements were formulated.
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