TY  - JOUR
A1  - Flawn Orpana, Ian
T1  - Manufacturing pharmaceutical medicines in a regulated environment - an auditor’s perspective
T2  - Procedia manufacturing
N2  - 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.
KW  - Pharmaceutical
KW  - Trend Analysis
KW  - Statisitcal Process Control Chart
KW  - SPC
KW  - Process Capability
KW  - Cp
KW  - Cpk
KW  - Process Performance
KW  - Pp
KW  - Ppk
KW  - Process Validation
KW  - Continuous Process Verification
KW  - State of Control
KW  - Performance Metrics
KW  - Statisitcal Control
Y1  - 2020
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/77557
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-775578
SN  - 2351-9789
VL  - 39.2019
SP  - 1773
EP  - 1782
PB  - Elsevier
CY  - Amsterdam
ER  -