Quality Management in Pharmaceutical Development of Biotechnology-Derived Medicinal Products: Implementation and Evaluation

نویسندگان

چکیده

Scientific relevance. One of the challenges associated with development medicines lies in creating a quality management system (QMS) and tools to assess its performance. Aim. The study aimed propose QMS model for biotechnology-derived medicinal products performance evaluation tool this universally applicable research centre company regardless specific activities individual divisions. Materials methods. analysed internal audit outcomes, non-compliance responses, document flow centre. Parameter values index (QI) calculations were entered into validated Microsoft Excel spreadsheets. Data analysis visualisation involved using Power Business Intelligence (BI) business analytics platform (mainly, BI Desktop Service components). Results. was implemented, authors proposed their all divisions Conclusions. QI collecting digital data, carrying out standardised monitoring, tracking status changes. is universal departments requirements, easy use, customisable by adding company-specific parameters. This makes not only drug but also other units.

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ژورنال

عنوان ژورنال: Vedomosti Nau?nogo centra èkspertizy sredstv medicinskogo primeneniâ

سال: 2023

ISSN: ['1991-2919', '2619-1172']

DOI: https://doi.org/10.30895/1991-2919-2023-549