Abstract
The International Council for Harmonization (ICH) “Q10 Pharmaceutical Quality Systems” (ICH Q10) guidance was introduced to address the growing gap between current good manufacturing practices and pharmaceutical manufacturing quality systems. This study evaluated the impact of the ICH Q10 guidance on the PQS of pharmaceutical manufacturers. Data were obtained from the enabler questionnaire from pharmaceutical manufacturers surveyed by the St. Gallen OPEX Benchmarking Program. These results represent the degree of implementation for enabler-focused questions based on a 5-point Likert scale self-assessment. Data analysis included a comparison of means and medians before and after the release of the ICH Q10 guidance and annual changes. There was a statistically significant difference for enabler implementation as a whole (p value < 0.0000), before and after the release of ICH Q10. Furthermore, statistically significant differences were observed for four of the five enabler categories (p values <0.05). In particular, the EMS enabler category showed a decrease in mean enabler score, suggesting the Management Responsibilities ICH Q10 PQS element was not effectively described or implemented. These results indicate that the release of ICH Q10 had a positive impact on the PQSs of pharmaceutical manufacturers. This was driven primarily by the changes observed in the TQM and JIT enabler categories and complimented by the TPM and BE categories. This would suggest that the Management Review, Change Management System, and Process Performance and Product Quality Monitoring System ICH Q10 PQS elements were all effectively described and implemented.
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Acknowledgements
The authors would like to thank Professor Thomas Friedli and his co-workers at the University of St. Gallen, Institute of Technology Management, for giving access to the OPEX benchmarking survey results.
Funding
This work was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR002378. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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Sean VanDuyse: Conceptualization, methodology, investigation, formal analysis, writing—original draft—visualization. Michael Fulford: methodology, writing—review and editing. Michael Bartlett: Conceptualization, methodology, writing—review and editing.
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VanDuyse, S.A., Fulford, M.J. & Bartlett, M.G. ICH Q10 Pharmaceutical Quality System Guidance: Understanding Its Impact on Pharmaceutical Quality. AAPS J 23, 117 (2021). https://doi.org/10.1208/s12248-021-00657-y
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DOI: https://doi.org/10.1208/s12248-021-00657-y