Аңдатпа
Relevance. Direct compression enables lozenge manufacturing without wet granulation and drying. However, variability in the properties of herbal extracts may affect the reproducibil-ity of critical quality attributes. Quality risk management within the Quality by Design frame-work supports systematic identification of variability sources and justification of a control strate-gy. Objective. To identify and assess quality risks during the development of a direct com-pression technology for lozenges containing dry Ajania fruticulosa (Ledeb.) Poljak extract. Materials and methods. Potential sources of variability were structured using an Ishika-wa cause-and-effect diagram. Risks were ranked using Failure Mode and Effects Analysis. Se-verity, occurrence, and detectability were assessed using five-point scales, and Risk Priority Numbers (RPNs) were calculated. Residual risks were predicted by expert reassessment of oc-currence and detectability under the proposed mitigation scenario, while severity scores re-mained unchanged. Results. Thirty-six potential variability factors were identified, and seven priority failure modes were selected for Failure Mode and Effects Analysis. Initial RPNs ranged from 18 to 48. Powder blend segregation during feeding into the hopper zone had the highest initial RPN. Un-der the proposed mitigation scenario, predicted residual RPNs ranged from 6 to 24. Six of the seven failure modes were classified as low risk, including five initially classified as medium risk. Powder blend segregation remained a medium risk requiring continued monitoring. Conclusions. The proposed control strategy provides a basis for further process devel-opment, technology transfer, and scale-up. Risk reduction represents an expert prediction and requires experimental confirmation through measurement of the corresponding critical quality attributes.