Access the full text.
Sign up today, get DeepDyve free for 14 days.
U . S Food and Drug Administration . Pharmaceutical cGMPs for the 21 st Century - A Risk - Based Approach Final Report
Andre Blanc, Loadmq TlME (1993)
Total Productive MaintenanceInternational Symposium on Semiconductor Manufacturing
Quality System (QS) Regulation/Medical Device Good Manufacturing Practices2018 02/06/21
T. Friedli, P. Basu, D. Bellm, J. Werani (2013)
Leading Pharmaceutical Operational Excellence
T. Cheng, S. Podolsky (1992)
Just-in-Time Manufacturing: An introduction
(2019)
FDA 483 Observations and Warning Letter Trends: Crowell & Moring
(2006)
Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
(2021)
https:// www
Javier García-Bernal, Marisa Ramírez-Alesón (2015)
Why and How TQM Leads to Performance ImprovementsQuality Management Journal, 22
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.Graphical abstract[graphic not available: see fulltext]
"The AAPS Journal" – Springer Journals
Published: Nov 12, 2021
Keywords: good manufacturing practices; ICH Q10; Pharmaceutical Quality Systems; The International Council for Harmonization
Read and print from thousands of top scholarly journals.
Already have an account? Log in
Bookmark this article. You can see your Bookmarks on your DeepDyve Library.
To save an article, log in first, or sign up for a DeepDyve account if you don’t already have one.
Copy and paste the desired citation format or use the link below to download a file formatted for EndNote
Access the full text.
Sign up today, get DeepDyve free for 14 days.
All DeepDyve websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.