Manufacturing pharmaceutical medicines in a regulated environment - an auditor’s perspective

  • The impact of the appropriate and inappropriately applied statistical metrics to verify the State of Control of pharmaceutical manufacturing has been reviewed from an auditor’s perspective. Good and bad statistical practices have been presented in an attempt for manufactures to appreciate the risks of using these metrics. Conclusions concerning (1) control charts to be used instead of line/run charts for trend analysis, (2) Ppk as the preferred capability index (but still with an ambition to get processes into statistical control), (3) show process capability indices along with their respective control charts (4) determine which Manufacturing State of Control the product/process lies in (5) an effective Control Strategy can only be implemented if the Manufacturing State of Control is understood, (6) when presenting data consider what is truly representative of the product/process and not the average (7) Management should align with ICH Q10 more effectively to provide statistical resources for their personnel.

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Author:Ian Flawn OrpanaORCiD
Parent Title (English):Procedia manufacturing
Place of publication:Amsterdam
Document Type:Article
Date of Publication (online):2020/02/25
Date of first Publication:2020/02/25
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Contributing Corporation:International Conference on Production Research Innovation (25. : 2019 : Chicago, Ill.)
Release Date:2023/10/23
Tag:Continuous Process Verification; Cp; Cpk; Performance Metrics; Pharmaceutical; Pp; Ppk; Process Capability; Process Performance; Process Validation; SPC; State of Control; Statisitcal Control; Statisitcal Process Control Chart; Trend Analysis
Page Number:10
First Page:1773
Last Page:1782
Institutes:Fachübergreifende Einrichtungen / Buchmann Institut für Molekulare Lebenswissenschaften (BMLS)
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - CC BY-NC-ND - Namensnennung - Nicht kommerziell - Keine Bearbeitungen 4.0 International