Current Good Manufacturing Practices (CGMPs) enforced by the FDA require that all manufacturing processes be validated. Validation ensures that controlling the inputs (i.e. parameters) within an acceptable range will consistently produce outputs (i.e. products) of acceptable quality. The current FDA view of CGMPs emphasizes a risk and science-based approach to biopharmaceutical manufacturing. As a result, Process Validation is viewed as a lifecycle, not a one-and-done activity. The FDA Guidance document “Process Validation: General Principles and Practices” presents Process Validation as a lifecycle with three stages or phases:
- Process Design
- Process Performance Qualification (PPQ)
- Continued Process Verification
Kymanox utilizes its broad technical and compliance expertise to successfully manage all aspects of Process Validation lifecycles for its clients. Some of the various sub-projects managed during the Process Validation lifecycle are:
- Analytical methods must be verified or validated to support process development and process control.
- Equipment, facilities, and utilities must be qualified before PPQ runs can begin.
- A well-defined control scheme must be developed to ensure the process consistently produces quality product. The control scheme must be defined prior to PPQ and verified during PPQ.
- The process must be well-characterized to assist with developing an appropriate sampling plan. The sampling plan will be used during PPQ and must produce data that is statistically significant.
Keeping all aspects of a Process Validation on track requires a combination of engineering, project management, and regulatory expertise. By using an integrated team in these three areas of expertise, Kymanox is able to quickly and efficiently execute validation activities that can and will exceed client expectations.