Engineer Forward - Transform Pharma Manufacturing
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This document proposes a systems approach to transforming the pharmaceutical manufacturing chain through the use of process analytic technology (PAT), industry standards like ISA-95, and systems engineering principles. It advocates applying these concepts holistically across the entire manufacturing lifecycle from raw materials to distribution in order to optimize processes, reduce costs and risks, and drive innovation through capabilities-based engineering.
Engineer Forward - Transform Pharma Manufacturing
- 1. Engineer Forward Principal Consultant david.daniel@casewise.com David Daniel A Systems Approach to Transforming the Pharmaceutical Manufacturing Chain
- 2. 2 © 2015 Casewise - confidential Solution Overview Holistic Model to Drive Optimization and Innovation Industry Standards PAT Framework System Engineering Principles Validation Standards Discover, Plan, Control and Implement Innovation in Pharmaceutical Manufacturing Corporate Insight Operational Data Industry Best Practices
- 3. 3 © 2015 Casewise - confidential Other Terms: • Good Automated Manufacturing Practice (GAMP) Set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry The Good Automated Manufacturing Practice Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes principles and procedures to help ensure pharmaceutical products have the required quality. KeyTerms and Standards Building Blocks for the Complete Analytic Solution Process Analytic Technology (PAT) is an FDA approved framework to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).* ANSI/ISA-95 is an international standard for developing interfaces between enterprise and control systems. (ISA-88 is a related control standard) * Adopted widely throughout the global pharmaceutical industry
- 4. 4 © 2015 Casewise - confidential FDA’s CallTo Action and Innovation Document Lays Out the Roadmap for the Future PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070305.pdf Recognizes the need for innovative thought, through engineering, to improve the pharmaceutical industry Lays the foundation for method in product process engineering (i.e. manufacturing) Sets the stage for holistic engineering from supply chain to manufacturing to distribution. Ties process engineering to requirements management. Ties holistic systems engineering to the risk- based approach of manufacturing.
- 5. 5 © 2015 Casewise - confidential InitialTransformation Reduces Risk Divide RiskAcross the Entire Manufacturing Lifecycle Raw Materials Process/Manufacture Batch Testing Distribution “Traditional” Manufacturing Process Risk Cost Time Raw Materials Process/ManufactureTest Test Distribution PAT (Inline) Manufacturing Process Risk Cost Time
- 6. 6 © 2015 Casewise - confidential ISA-95 Overview HolisticView OptimizesVertically and Horizontally Enterprise Site/Plant Site/Plant Site/Plant Area Area Area Batch Batch Continuous Continuous Discrete Discrete Area Area Area Batch Continuous Continuous Continuous Batch Discrete Area Area Area Batch Batch Batch Continuous Discrete Discrete Levels0–4(+2) Enterprise Work Site Work Area Work Center Work Unit Work Equipment Work Asset 0 1 2 3 4 (1) (2) Business Planning and Logistics Manufacturing and Operations Control Batch Control Continuous Control Discrete Control ISA-88 Controls Level Data Span of Control
- 7. 7 © 2015 Casewise - confidential One CommonView Casewise Captures AllAspects of the Business in a Unified Repository Standards, Principles and Best Practices Business Process Technology Data RequirementsPerformersOrganization Strategy External Systems Resources Capital and Operational Planning Capability Infrastructure Network
- 8. 8 © 2015 Casewise - confidential Model to Capabilities Unique Configurations of Process, Actions, Resources, and People Capability One Process 1 Process 2 Process 3 Test X Test Y Capability Two Process A Process B Process C Test Alpha Test Beta
- 9. 9 © 2015 Casewise - confidential Capabilities Control and Optimize Process Operational Optimization Drives Efficient Use of Resources Raw Materials Process/ManufactureTest Test Distribution PAT (Inline) Manufacturing Process Risk Cost Time Capabilities Available to Combine and Recombine Raw Materials Process/ManufactureTest Test Distribution Optimized Manufacturing Process Risk Cost Time
- 10. 10 © 2015 Casewise - confidential Engineered Innovation Building Blocks for the Science of Innovation = Optimized Process/Existing Product ± = Improved Process/Product + = New Process/Products + = Innovative Process/Products Underpinning Analysis Standards Based Manufacturing Controls Sound Systems Engineering Auditable Results Strategic Alignment Organizational Change Management Resource Management Product Portfolio Management
Editor's Notes
- #3: What's the problem that you're solving? Method to build a pharma manufacturing enterprise in the abstract, using FDA’s PAT framework leveraging ISA-95 (industry standard), to model future process states and validate against GAMP standards. Why is the problem important and what is the business value? Provide a unique method to assist pharma’s to transition existing processes to the new FDA approved process optimizing their production lines glean new products from existing capabilities engineer innovation in the production area. Why is your solution better than other solution that exist State of the art in the industry uses real time and historical SCADA data to tailor production lines. Because this situation limits possibilities to the known, it limits engineering innovation to the boundaries of the ‘real world’, not theoretical as you can do in the abstract. Additionally, by including the other domains of enterprise architecture, a holistic look at the pharma allows Organizational change Supply chain optimization External systems optimization
- #4: One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.