Abstract
The aim of this study was to evaluate the impact of Periodic Product Review (PPR) on improvements in the production process of pharmaceuticals by statistically analyzing the in-process control of the parameters average weight by coating and hardness. Methods. For this purpose, a case study was conducted in a pharmaceutical industry analyzing the statistical PPR data of a coated tablet from 2021 and 2022. Diagrams and tables based on probability and statistical theory were used for the analysis. Results. The data analysis revealed that PPR was effective in helping to identify problems in the production process, which were then resolved. As a result, the production performance of this drug product was significantly improved, as evidenced by the reduction in the variability of analytical results and process performance indicators within the acceptable range. Conclusion. The results of this work show that PPR is an important tool for ensuring the quality of pharmaceutical products. Statistical analysis of PPR data makes it possible to identify trends and patterns that may indicate the need for improvements in the production process.
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