Best Practices in Statistical Process Monitoring ... - IBC Life Sciences

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2. How to Respond to OOT Signals: Specification, Action, and Statistical Control Limits Specification Limit: “Voice of Customer” Set based on process capability, regulatory expectations and product safety concerns Action Limits: PV Acceptance Criteria, Batch record limits Statistical Control Limit: “Voice of Process” +/- 3 for n> 15 and/or PpK ≥ 1.33 Set based on process characterization and/or large scale data Paul MaCormac
2. How to Respond to OOT Signals: Potential Map from PCS Classification to Signal Response Variable Acceptable Range Normal Operating Range Statistical Control Limits Attributes CQAs* Specification/IS In-Process Control (IPC) Consistency Indicator (later) Process Indicator (real-time) Critical Deviation Major Deviation deviation N/A N/A Technical review DCS Alarm OOT/ APR Review Immediate alert OOT / APR Review Immediate alert Technical review Immediate alert Aggregate as CI Potential MVA** Parameters Critical Process Parameter (CPP)* Key process parameter (highly controlled) Non-KPP(nKPP) (no step impact) Major Deviation deviation DCS Alarm DCS Alarm Technical review Potential MVA Technical review Potential MVA *Defined in ICH Q8 **Multivariate Analysis
Page 1 and 2: IBC Process2Product Oct 4 th , 2011
Page 3 and 4: Origins: BPOG Data Analysis Working
Page 5 and 6: SPC Driver - FDA Validation Guidanc
Page 7 and 8: Goals of Effective SPC Program ●
Page 9: 1. How to Choose which Variables to
Page 13 and 14: 3. How to Manage OOT Response Team
Page 15 and 16: 5. How and When to Define Control L
Page 17 and 18: 7. When & How to use Western Electr
Page 19: Summary: Key Success Factors in SPC

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