ANALYSIS OF QUALITY INDICATORS AND PARAMETRS OF SYRUP AMBROXOL PRODUCTION USING STATISTICAL METHODS

S. N. Egorova, M. R. Mtsariashvili, V. A. Sevodin, S. Yu. Garmonov
2019 Drug development & registration  
The quality review procedure, which is an essential improvement of the quality system by manufacturers, was used for monitoring the stability of the production process and quality of Ambroxol syrup. The quality review of Ambroxol syrup was carried out, using Shewhart's control charts. Reproducibility and stability of the manufacturing process of the drug product were evaluated with respect to a set of parameters.
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