The FDA’s Process Validation Guidance calls for “Continued Process Verification” in Stage 3 of the Guidance which focuses on continual assessment of process performance and product quality throughout the life of the product. Combining process control with process improvement creates a system that satisfies the direction of ICH Q8 (R2) and FDA’s guidance for continued process verification, continuous improvement and life cycle management. This presentation describes a disciplined and structured “Quality by Design” approach to achieve this objective.
The QbD “Design Space” concept has been given much attention by pharma and biotech industries but much less attention has been given to implementation of “process control” systems needed to keep the process in-control and consistently producing quality product. Process data are routinely analyzed at two levels to assess process stability and capability. During the production of each batch data are collected by the process operators and Quality Control to assure within batch stability and capability and that appropriate actions are taken when needed. On a monthly or quarterly basis, the batch-to-batch variation in product parameters is analyzed to assess the long-term stability and capability of the process. This system is illustrated and discussed in detail. Critical questions and challenges are identified. Connections of this system to process robustness are also addressed.
Areas Covered in the Session :
FDA Guidance regarding Process Validation and Continued Process Verification
Building Blocks of QbD – Design Space, Process Control and Assessing Risk
Process Control Strategy – Stability and Capability Methods
Process Performance and Product Quality – A Systems Approach
The Vision for Process Monitoring and Control Building Blocks
Successful Deployment, Getting Started and Sustaining the Initiative
Tips and traps – What to watch out for
Who Should Attend:
Executives and Managers of Pharma and Biotech Companies
Process and Manufacturing Engineers
Quality Assurance Departments
Regulatory Affairs Departments
Quality Control Lab Personnel
Quality Engineers
Research and Development Departments
Biologists and Microbiologists
Chemists and Chemical Engineers