ABSTRACT
This chapter describes key statistical tools used in Continued Process Verification (CPV), Stage 3 of the Process Validation Life Cycle described in the 2011 FDA Guidance for Industry Process Validation: General Principles and Practices. The chapter provides the statistical basis for these tools and characteristics of typical biopharmaceutical CPV data and practices that influence their use. The goals of CPV are defined, and the importance of incorporation of these goals into analysis and interpretation is made clear.
The distinction between Phase 1 and Phase 2 SPC applications is defined. The alignment of CPV with a Phase 1 application, and the critical implications for the design of a CPV program are explained. The importance of proper interpretation of standard quality control terms such as common and special cause variation, and statistical/process control in the context of CPV is discussed, including recommendations for related actions. Control chart discussions focus mainly on the most commonly used chart, the Shewhart control chart. The chapter incudes a section on other charts that could be employed. In addition to statistical considerations, practical guidance on the development and implementation of other elements of a CPV program is provided.
