Continued Process Verification - a Systems Approach Including Tips and Traps

• Activity Number: 566 - Recent Advances in Quality Statistics and Process Validation of Pharmaceuticals
• Type: Topic Contributed
• Date/Time: Wednesday, August 2, 2017 : 2:00 PM to 3:50 PM
• Sponsor: Section on Risk Analysis
• Author(s): Ronald D Snee*
• Companies: Snee Associates, LLC
• Keywords: Statistical Systems ; Continued Process Verification ; Process Variation ; Process Control ; Process Stability ; Statistical Engineering

Abstract

FDA's Process Validation Guidance Stage 3 - Continued Process Verification (CPV) calls for "ongoing assurance is gained through routine production that the process remains in a state of control." Two critical considerations in assessing process behavior are process stability and capability. Tools commonly used to demonstrate that a process is in a state of control include: control charts, process capability indices, analysis of variance and graphics. Unexpected problems are often encountered when using these tools. A systems approach to CPV including "tips and traps" is presented. The system enables users to develop effective process monitoring systems and avoid commonly encountered problems and pitfalls. The issues discussed include: design and implementation of a systems approach, how to reduce false out of control signals, measures of process stability, the identification of causes of out of control signals. The approaches and tools discussed are illustrated with case studies and examples.