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Case Studies

BACKGROUND

• Deployment and validation of multiple PAT analysers
• PAT analyser integration with Global PAT management tool
• Deployment across world-wide manufacturing and R&D facilities
• Data management, integrity and security processes

OBJECTIVES

• Enhance process understanding, streamline technical transfer, increase production throughput and reduce off-line laboratory testing
• Meet regulatory expectations i.e. FDA’s 21st Century GMP Guidance
• Facilitate greater understanding of process design space through implementation of Quality by Design (QbD)
• Ensure deployed technologies are validated and supported

ROLE

• Determine PAT techniques that yield maximum benefit
• Design integration of PAT toolset with production processes
• Validate PAT toolset
• Facilitate senior management commitment to PAT proposals and deployment of improvements
• Update QMS policies/standards/processes to adopt PAT

OUTCOMES

• Greater understanding of unit operations
• Increased manufacturing throughput
• Reduced reliance on laboratory confirmation testing
• Reduction in failed batches leading to an increase in OEE

CHALLENGES

• Integration with existing processing equipment
• QMS policies/standards/processes not designed to work with PAT
• Establishing cross functional / discipline teams
• Engagement of Business ,  IS/IT and Quality leadership
• Relationship and conflicts with parallel business initiatives

BENEFITS

• Product quality and performance are assured
• Product and process specifications based on formulation process understanding
• PAT risk-based approach accepted by regulators
• Continuous quality assurance, real time release possibilities