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April 13, 2026SHILAP Revista de lepidopterologíaOpen Access

Risk analysis in the production of hard capsules under the conditional name “Praziquantel plus” using the Ishikawa diagram method

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Authors

KSK.V. SemchenkoVIV.K. IakovenkoOSO.O. Shmalko

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Overview

This analysis identifies production risks in hard capsules using the Ishikawa diagram, highlighting process improvements.

Key Points

  • The research analyzes risks in producing hard capsules called 'Praziquantel Plus' through the Ishikawa diagram method.
  • Applied the Ishikawa diagram for risk assessment
  • Followed ISO 9001, GMP, and ICH Q10 standards
  • Conducted cluster analysis and cause-and-effect analysis
  • Developed risk assessment tables for raw materials and processes
  • Created a tailored Ishikawa diagram for production risks
  • Identified critical risk factors in active ingredients and production processes
  • Outlined precautionary measures to mitigate risks
  • Structured the Ishikawa diagram around six primary risk categories
  • Mapped interrelations between key risk factors
  • Provided a framework for quality management and process optimization

Cite This Study

Semchenko et al. (2026) studied this question.

synapsesocial.com/papers/69dc874a3afacbeac03e9b53https://doi.org/10.26641/2307-0404.2026.1.356985
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