Facility Design for Sustainable Global Compliance

1,191 views

Published on

Presented at ISPE China Conference, Beijing 2010-10-15.

  • Be the first to comment

Facility Design for Sustainable Global Compliance

  1. 1. New Facility & Process Strategies Facility Design for Sustainable Global Compliance Brian White Manager of Business Development CDI-Life Sciences
  2. 2. New Facility & Process Strategies <ul><li>Today’s Pharmaceutical Industry is increasingly driven by Cost Pressure. </li></ul><ul><li>From consumers (people, governments, insurers) </li></ul><ul><li>From a growing list of qualified global competitors </li></ul><ul><li>From rising costs of resources (energy, labor, material) </li></ul><ul><li>Powerful Tools to fight Cost Pressure: </li></ul><ul><li>Lean Manufacturing </li></ul><ul><li>Quality by Design </li></ul><ul><li>Sustainable Design </li></ul>
  3. 3. New Facility & Process Strategies <ul><li>Today’s Pharmaceutical Industry is witness to unprecedented globalization </li></ul><ul><li>Driven by cost pressures. </li></ul><ul><ul><li>From consumers (people, governments, insurers) </li></ul></ul><ul><ul><li>From a growing list of qualified global competitors </li></ul></ul><ul><ul><li>From rising costs of resources (energy, labor, material) </li></ul></ul><ul><li>We see increasing demand in emerging markets </li></ul><ul><ul><li>Rising standards of living </li></ul></ul><ul><ul><li>Diminishing cost of goods </li></ul></ul><ul><li>We enjoy increased access to global markets </li></ul><ul><ul><li>Facilitated by Harmonization of global quality standards </li></ul></ul><ul><ul><li>Driven by local demand and cost pressure </li></ul></ul>
  4. 4. New Facility & Process Strategies Lean Manufacturing <ul><li>Lean Manufacturing. </li></ul><ul><li>Production Practice that recognizes that expending any resource toward any goal that does not add value is wasteful </li></ul><ul><li>Value is defined as any action or process that the customer would be willing to pay for. </li></ul><ul><li>Lean is a set of tools that help to eliminate waste </li></ul><ul><li>Value Stream Mapping (process flow, man/material flow) </li></ul><ul><li>Kan-Ban (pull systems) </li></ul><ul><li>Poko-Yoke (error proofing) </li></ul><ul><li>Lean is Cost Reduction through the Elimination of Waste </li></ul>
  5. 5. New Facility & Process Strategies ▪ Quality by Design <ul><li>Quality by Design. </li></ul><ul><li>The belief that “Quality can be Planned” and that most “Quality problems relate to the way that quality was planned”. </li></ul><ul><li>Quality by Design principles have been used to advance product and process quality in every industry, and particularly the automotive industry. </li></ul>
  6. 6. New Facility & Process Strategies - Quality by Design <ul><li>Quality by Design. </li></ul><ul><li>Recently has been adopted by the U.S. Food and Drug Administration (FDA) as a vehicle for the transformation of how drugs are discovered, developed, and commercially manufactured. </li></ul><ul><li>This FDA imperative is best outlined in its report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach.” </li></ul>
  7. 7. New Facility & Process Strategies - Sustainable Design <ul><li>Sustainable Design. </li></ul><ul><li>Sustainability is improving the quality of human life while living within the carrying capacity of supporting eco-systems </li></ul>
  8. 8. New Facility & Process Strategies - Sustainable Design <ul><li>Sustainable Design </li></ul><ul><ul><li>Renewable Materials of Construction </li></ul></ul><ul><ul><li>Efficient Systems </li></ul></ul><ul><ul><li>Minimizing Waste </li></ul></ul><ul><ul><li>Maximize Recovery </li></ul></ul>
  9. 9. Case Study Confidential Client, Southern China <ul><li>Highlights </li></ul><ul><li>New Oral Dosage Manufacturing Facility </li></ul><ul><li>Redevelopment zone (brown-field site) </li></ul><ul><li>Quality by Design </li></ul><ul><ul><li>Impact Assessment with Preliminary Design to Identify Critical Systems </li></ul></ul><ul><ul><li>Risk Analysis for Critical Systems </li></ul></ul>
  10. 10. Case Study Confidential Client, Southern China <ul><li>Project Team - The Client </li></ul><ul><li>US Based Firm bringing… </li></ul><ul><ul><li>familiarity w/Formulation </li></ul></ul><ul><ul><li>Manufacturing Expertise </li></ul></ul><ul><ul><li>QA/QC & Regulatory Requirements </li></ul></ul><ul><ul><li>Marketing & Distribution </li></ul></ul><ul><ul><li>Chinese JV Partner </li></ul></ul><ul><ul><li>Financing & Construction Site </li></ul></ul><ul><ul><li>Key site-support staff </li></ul></ul>
  11. 11. Case Study Confidential Client, Southern China <ul><li>Project Team – Design & Construction </li></ul><ul><li>Economic Design Solution </li></ul><ul><li>US Engineer – CDI Life Sciences </li></ul><ul><ul><li>Brings GMP expertise </li></ul></ul><ul><ul><li>Process & Facility Expertise in Pharmacutical Manufacturing </li></ul></ul><ul><ul><li>Coordinate FDA review of design basis </li></ul></ul><ul><ul><li>Conceptual Design through BOD </li></ul></ul><ul><ul><li>Procurement Support for Critical Process Systems </li></ul></ul>
  12. 12. Case Study Confidential Client, Southern China <ul><li>Project Team – Design & Construction </li></ul><ul><li>China Engineer & Constructor – Maison Worley Parsons </li></ul><ul><ul><li>Detail Design – Local Expertise </li></ul></ul><ul><ul><li>Procurement & Construction Management </li></ul></ul><ul><ul><li>Qualify Local Suppliers & Contractors (International Grade) </li></ul></ul><ul><ul><li>Coordinate Government Submittals (PEP) </li></ul></ul>
  13. 13. Case Study Confidential Client, Southern China <ul><li>Project Approach </li></ul><ul><li>Lean Manufacturing – Value Stream Mapping </li></ul><ul><ul><li>Manage Adjacencies from a Lean Perspective </li></ul></ul><ul><ul><li>Material & Personnel Flow Analysis </li></ul></ul><ul><ul><li>Reduce low-value movement of materials & personnel </li></ul></ul><ul><li>Quality by Design </li></ul><ul><ul><li>Manage Adjacencies - reduce risk of contamination </li></ul></ul><ul><ul><li>Impact Assessment after Preliminary Design </li></ul></ul><ul><ul><li>Risk Analysis </li></ul></ul><ul><li>Sustainability </li></ul><ul><ul><li>Minimizing Classified Space – (energy savings) </li></ul></ul><ul><ul><li>And Maximizing Adjacencies </li></ul></ul>
  14. 14. Case Study Confidential Client, Southern China Site Master-Plan
  15. 15. Case Study Confidential Client, Southern China Floor-Plan
  16. 16. Case Study Confidential Client, Southern China Material Flow
  17. 17. Case Study Confidential Client, Southern China Personnel & Gowning Flow
  18. 18. Case Study Confidential Client, Southern China Equipment & Waste Flow
  19. 19. Case Study – Confidential Client, Southern China Minimize Classified Space
  20. 20. Case Study – Confidential Client, Southern China <ul><li>Project Approach – Lean Considerations </li></ul><ul><li>These Studies at the Conceptual/Preliminary Phase Meet Lean Objectives by eliminating waste. </li></ul><ul><ul><li>Wasted Movement - movement of materials & people can be minimized by analyzing Material and Personnel Flows and organizing the facility to maximize adjacencies </li></ul></ul><ul><ul><li>Transport - moving products that is not actually required to perform the processing can be minimized by employing an MRP System assures that the correct materials are available in the correct quantities at the correct time </li></ul></ul>
  21. 21. Case Study – Confidential Client, Southern China <ul><li>Project Approach – Lean Considerations </li></ul><ul><li>Inventory - all components, work-in-process and finished product not being processed </li></ul><ul><ul><li>The customer does not want to pay for inventory carrying costs as such a major lean objective is to minimize inventories (raw material, work-in-process or WIP, finished goods) </li></ul></ul><ul><ul><li>Again an MRP system is used to minimize excess inventory </li></ul></ul><ul><li>Waiting - waiting for the next production step (a type of WIP) </li></ul><ul><li>Overproduction - production ahead of demand (can be WIP or finished goods) </li></ul>
  22. 22. Case Study – Confidential Client, Southern China <ul><li>Project Approach – Lean Considerations </li></ul><ul><li>Motion - people or equipment moving or walking more than is required to perform the processing </li></ul><ul><ul><li>Managed in the design process by improving adjacencies </li></ul></ul><ul><li>Over Processing - resulting from poor tool or product design creating activity </li></ul><ul><ul><li>Includes effort expended producing better quality than required to meet specifications </li></ul></ul><ul><ul><li>Managed in the design process by specifying appropriate processes, equipment and systems </li></ul></ul><ul><li>Defects - the effort involved in inspecting for and fixing defects </li></ul>
  23. 23. Quality by Design - Impact Assessment <ul><ul><ul><li>The ISPE Commissioning Guide considers the Impact Assessment as “one of the most important activities in defining the Commissioning and Qualification scope of a project.” </li></ul></ul></ul><ul><ul><ul><li>The Impact Assessment identifies the various systems : process, process support, utility and facility and miscellaneous equipment in a manufacturing facility and determines if the operating, controlling, alarming or failure of a system or an equipment component of that system has an impact on product quality. </li></ul></ul></ul><ul><ul><ul><li>Of special concern is identifying those systems that have a Direct Impact on quality and the equipment items within those Direct Impact systems that should be considered Critical Components of the manufacturing facility. </li></ul></ul></ul>
  24. 24. Quality by Design - Impact Assessment <ul><li>Considering… </li></ul><ul><ul><ul><li>Operation </li></ul></ul></ul><ul><ul><ul><li>Control </li></ul></ul></ul><ul><ul><ul><li>Alarm </li></ul></ul></ul><ul><ul><ul><li>Failure </li></ul></ul></ul><ul><li>To assign impact on product quality as either </li></ul><ul><ul><ul><li>Direct </li></ul></ul></ul><ul><ul><ul><li>Indirect </li></ul></ul></ul><ul><ul><ul><li>No Impact </li></ul></ul></ul><ul><li>Evaluating Systems including </li></ul><ul><ul><ul><li>Process </li></ul></ul></ul><ul><ul><ul><li>Process Support </li></ul></ul></ul><ul><ul><ul><li>Utility & Facility </li></ul></ul></ul><ul><ul><ul><li>Miscellaneous </li></ul></ul></ul>Step-1: Impact Assessment
  25. 25. Quality by Design - Impact Assessment <ul><ul><li>Direct Impact Systems </li></ul></ul><ul><ul><ul><li>Process Equipment </li></ul></ul></ul><ul><ul><ul><li>Critical Utilities </li></ul></ul></ul>
  26. 26. Quality by Design - Impact Assessment <ul><ul><li>Indirect Impact Systems </li></ul></ul><ul><ul><ul><li>Air-Handlers </li></ul></ul></ul><ul><ul><ul><li>Utility Systems </li></ul></ul></ul><ul><ul><li>No Impact </li></ul></ul><ul><ul><ul><li>General Heating/Cooling </li></ul></ul></ul><ul><ul><ul><li>Office / Lab Equipment </li></ul></ul></ul><ul><ul><ul><li>Waste Treatment </li></ul></ul></ul>
  27. 27. Quality by Design - Impact Assessment <ul><li>For direct impact systems </li></ul><ul><ul><li>Identify critical components </li></ul></ul><ul><li>Assign validation requirements </li></ul><ul><ul><li>Commissioning all systems: Direct, Indirect, None </li></ul></ul><ul><ul><li>Qualification for systems w/Impact: Direct & Indirect </li></ul></ul><ul><ul><li>PQ: Direct Impact Systems </li></ul></ul>
  28. 28. <ul><li>Built Upon Equipment List </li></ul>Quality by Design - Impact Assessment
  29. 29. <ul><li>The Value of the Impact Assessment </li></ul><ul><ul><li>Defines limit of full validation (usually less than 100%) </li></ul></ul><ul><ul><li>Defines subjects of risk analysis (usually critical systems or components only) </li></ul></ul><ul><ul><li>Documents validation requirements and their basis </li></ul></ul>Quality by Design - Impact Assessment
  30. 30. Quality by Design - Risk Analysis <ul><li>Underlying Documents </li></ul><ul><ul><li>ICH Q8 </li></ul></ul><ul><ul><li>ICH Q9 </li></ul></ul><ul><ul><li>ASTM E2500-07 </li></ul></ul><ul><ul><li>Impact Assessment </li></ul></ul><ul><li>Analysis Objectives </li></ul><ul><ul><li>Focus on direct impact components </li></ul></ul><ul><ul><li>Correlate risk directly to product integrity or patient health </li></ul></ul><ul><ul><li>Establish or vindicate design requirements </li></ul></ul>Step-2: Risk Analysis
  31. 31. Quality by Design - Risk Analysis <ul><li>Risk Methodology </li></ul><ul><ul><li>Modified FMECA (Failure Mode, Effects and Criticality Analysis) Method </li></ul></ul><ul><li>Risk = Severity x Frequency x Anticipation </li></ul>
  32. 32. Quality by Design - Risk Analysis <ul><li>Severity is Science -Based </li></ul><ul><ul><li>Design space sets operating limits </li></ul></ul><ul><ul><li>Critical process parameters affect quality </li></ul></ul><ul><ul><li>Consequences of straying outside design space </li></ul></ul><ul><ul><li>Quality effects on patient health </li></ul></ul>
  33. 33. Quality by Design - Risk Analysis <ul><li>Frequency is Engineering -Based </li></ul><ul><ul><li>F – Value = Frequency of Failure </li></ul></ul><ul><ul><li>Influences equipment selection </li></ul></ul>
  34. 34. <ul><li>Anticipation is Engineering -Based </li></ul><ul><ul><li>A – Value = Anticipation of Failure </li></ul></ul><ul><ul><li>Influences control selection </li></ul></ul><ul><li>F x A, Not S, is Engineering -Based </li></ul>Quality by Design - Risk Analysis
  35. 35. Quality by Design - Risk Analysis <ul><li>Worksheet aids analysis </li></ul><ul><ul><li>One for each direct impact system record of </li></ul></ul><ul><ul><ul><li>Selected critical process parameters </li></ul></ul></ul><ul><ul><ul><li>Design spaces </li></ul></ul></ul><ul><ul><ul><li>Consequences on product quality severities </li></ul></ul></ul><ul><ul><li>Recommends </li></ul></ul><ul><ul><ul><li>Allowable F-Values </li></ul></ul></ul><ul><ul><ul><li>Allowable A-Values </li></ul></ul></ul><ul><li>Direct results </li></ul><ul><ul><li>No prioritization required </li></ul></ul><ul><ul><li>Work within allowable F - & A - Values </li></ul></ul>
  36. 36. Quality by Design - Risk Analysis <ul><li>Value of the risk analysis </li></ul><ul><ul><li>Early identification of design requirements </li></ul></ul><ul><ul><li>Minimizes over-design </li></ul></ul><ul><ul><li>Minimize re-work due to under-design </li></ul></ul>
  37. 37. Summary <ul><li>For all New Facilities and Major Renovations: </li></ul><ul><ul><li>Manufacturers must consider the benefits of designing a facility to meet Global Regulatory Expectations (SFDA, FDA, EMEA) </li></ul></ul><ul><ul><li>And the potential Savings afforded by QbD, Lean and a Risk Based Approach to Validation. </li></ul></ul>
  38. 38. About The Presenter <ul><li>Brian White </li></ul><ul><li>Brian White is Manager of Business Development for CDI-Life Sciences. He has over 20 years of experience working in various technical, sales and marketing roles supporting facilities, equipment, systems and services for the pharmaceutical & biotech industry and the broader healthcare market. Experience includes the design, construction, installation, commissioning and validation of process and utility systems. He is active at the regional and international level of ISPE (International Society for Pharmaceutical Engineering) and is currently the VP of Programs for the Delaware Valley Chapter. </li></ul><ul><li>About CDI - </li></ul><ul><ul><li>CDI-Life Sciences is a full-service engineering group supporting the entire life cycle of a client’s pharmaceutical or biotech production and/or research and development facility from initial concept to construction and qualification. CDI-Life Sciences’ professionals have expertise in the design, construction and validation of a diverse array of Life Sciences facilities, including API, Biologics, Vaccines, Sterile Liquids, Oral Solid Dosage manufacturing and R&D facilities. CDI-Life Sciences has extensive experience performing work that complies with USFDA, EU and other worldwide regulatory agencies. </li></ul></ul><ul><li>About MWP – </li></ul><ul><li>MaisonWorleyParsons is the largest international EPC & EPCM Contractor in China, serving Pharmaceutical, Oil & Gas, Refining, Chemicals, Power, Infrastructure & Environmental sectors. With major offices in Beijing, Shanghai, Tianjin, Lianyungang, Nanjing and Shenyang, MaisonWorleyParsons has successfully executed over 300 projects in the past 10 years and maintains a remarkable record of more than 48 million safe field man-hours without a single lost time injury in China. </li></ul>

×