Using Software Systems to Drive a Successful CPV Program

Whitepaper

Want smarter manufacturing data management? The key is using software systems to drive a successful CPV program.

This paper will help you streamline your search for the right system. It provides key insights on how purpose-built data management systems can be incorporated into your CPV program to meet FDA requirements and protect and improve your business. The whitepaper refers to many of the required elements discussed in BPOG’s ‘Continued Process Verification Paper with Example Plan’

Key points: 

  • CPV requires proper planning
  • The right product data management system collects and transforms the specific data required for CPV into the requisite outputs with the least amount of resources
  • Get the most value from a system by understanding the components of CPV planning

Why is continued process verification important?

An area of life science that has recently received significant attention around data, its integrity and management processes, is manufacturing. One key contributor to this focus is the 2011 publication of the FDA’s “Process Validation: General Principles and Practices.” Within this guideline for process validation, the third and final stage of process validation – “Continued Process Verification (CPV)” – states that manufacturers must provide continual assurance that their manufacturing process remains in control over time. Each manufacturer must put plans and processes in place to collect and analyze end-to-end production and process data to ensure product outputs are within predetermined quality limits. The plan must also ensure the process remains in statistical process control (SPC) – noting that while there may not be “failures” of an individual batch, a process may start to drift out of control, leading to the likelihood of future batch failures. The goal of SPC, and its incorporation into CPV, is to prevent those failures from occurring.

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