Smarter Manufacturing Data Management – Using Software Systems To Drive A Successful CPV Program

Data is prevalent through all functions of the Life Science industry. Its value impacts many disciplines throughout an organization, and while the use of data by discipline varies, it always involves:

• Gathering and aggregating multiple types of data from multiple sources
• Making that data available across an organization
• Subjecting it to statistical analysis
• Extracting knowledge from it, and
• Using those insights to correct problems and capitalize on opportunities

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, 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.

Although the FDA does not specify how an organization should execute CPV, Stage 3 of the Guidance suggests, “A system for detecting departures from the process as designed is essential to accomplish this goal.” While it is possible to meet the requirements of CPV through manual efforts, or use of common Office applications, these approaches are likely sources of errors, can lead to long lead times for report availability, and are labor intensive.

Life Science manufacturers and CMOs who secure and streamline their data management and process control strategy for CPV by leveraging the latest data management systems are on the forefront of ensuring compliance, timeliness and operational efficiency throughout their manufacturing operations.

The current environment of manufacturing data management systems can be complex. Data is collected by different groups, sites and partner organizations. Additionally, data is managed in multiple places – spreadsheets, paper-based systems, and disparate data silos.

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 following content refers to many of the required elements discussed in BPOG’s ‘Continued Process Verification Paper with Example Plan’.

Starting with the basics, a successful CPV program begins with a formal CPV plan. The components of a plan include:

• Process Definition
• Data Collection
• Limits Management
• Process Trending & Analysis