Facility Design for Sustainable Global Compliance
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Transcript of Facility Design for Sustainable Global Compliance
ISPE-CCPIE CHINA CONFERENCE 2010
October 26-29 2010 Beijing
New Facility & Process Strategies
Facility Design for
Sustainable Global Compliance Brian White
Manager of Business Development
CDI-Life Sciences
ISPE-CCPIE CHINA CONFERENCE 2010
New Facility & Process Strategies
Today’s Pharmaceutical Industry is increasingly driven by Cost Pressure.From consumers (people, governments, insurers)From a growing list of qualified global competitorsFrom rising costs of resources (energy, labor, material)
Powerful Tools to fight Cost Pressure:Lean ManufacturingQuality by DesignSustainable Design
ISPE-CCPIE CHINA CONFERENCE 2010
New Facility & Process StrategiesLean Manufacturing
Lean Manufacturing.Production Practice that recognizes that expending any resource toward any goal that does not add value is wastefulValue is defined as any action or process that the customer would be willing to pay for.Lean is a set of tools that help to eliminate wasteValue Stream Mapping (process flow, man/material flow)Kan-Ban (pull systems)Poko-Yoke (error proofing)
Lean is Cost Reduction through the Elimination of Waste
ISPE-CCPIE CHINA CONFERENCE 2010
New Facility & Process Strategies▪Quality by Design
Quality by Design.
•The belief that “Quality can be Planned” and that most “Quality problems relate to the way that quality was planned”.
•Quality by Design principles have been used to advance product and process quality in every industry, and particularly the automotive industry.
ISPE-CCPIE CHINA CONFERENCE 2010
New Facility & Process Strategies - Quality by Design
Quality by Design.
•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.
•This FDA imperative is best outlined in its report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach.”
ISPE-CCPIE CHINA CONFERENCE 2010
New Facility & Process Strategies - Sustainable Design
Sustainable Design.
•Sustainability is improving the quality of human life while living within the carrying capacity of supporting eco-systems
ISPE-CCPIE CHINA CONFERENCE 2010
New Facility & Process Strategies - Sustainable Design
• Sustainable Design Renewable
Materials of Construction
Efficient Systems Minimizing Waste Maximize Recovery
ISPE-CCPIE CHINA CONFERENCE 2010
Case StudyConfidential Client, Southern China
Highlights New Oral Dosage Manufacturing Facility Redevelopment zone (brown-field site) Quality by Design
Impact Assessment with Preliminary Design to Identify Critical Systems
Risk Analysis for Critical Systems
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study Confidential Client, Southern China
Project Team - The Client US Based Firm bringing…
familiarity w/Formulation Manufacturing Expertise QA/QC & Regulatory Requirements Marketing & Distribution Chinese JV Partner Financing & Construction Site Key site-support staff
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study Confidential Client, Southern China
Project Team – Design & Construction Economic Design Solution US Engineer – CDI Life Sciences
Brings GMP expertise Process & Facility Expertise in Pharmacutical
Manufacturing Coordinate FDA review of design basis Conceptual Design through BOD Procurement Support for Critical Process Systems
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study Confidential Client, Southern China
Project Team – Design & Construction China Engineer & Constructor – Maison Worley Parsons
Detail Design – Local Expertise Procurement & Construction Management Qualify Local Suppliers & Contractors (International
Grade) Coordinate Government Submittals (PEP)
ISPE-CCPIE CHINA CONFERENCE 2010
Case StudyConfidential Client, Southern China
Project Approach Lean Manufacturing – Value Stream Mapping
Manage Adjacencies from a Lean Perspective Material & Personnel Flow Analysis Reduce low-value movement of materials & personnel
Quality by Design Manage Adjacencies - reduce risk of contamination Impact Assessment after Preliminary Design Risk Analysis
Sustainability Minimizing Classified Space – (energy savings) And Maximizing Adjacencies
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study Confidential Client, Southern China
Site Master-Plan
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study Confidential Client, Southern China
Floor-Plan
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study Confidential Client, Southern China
Material Flow
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study Confidential Client, Southern China
Personnel & Gowning Flow
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study Confidential Client, Southern China
Equipment & Waste Flow
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study – Confidential Client, Southern ChinaMinimize Classified Space
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study – Confidential Client, Southern China
Project Approach – Lean Considerations These Studies at the Conceptual/Preliminary Phase Meet
Lean Objectives by eliminating waste. Wasted Movement - movement of materials &
people can be minimized by analyzing Material and Personnel Flows and organizing the facility to maximize adjacencies
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
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study – Confidential Client, Southern China
Project Approach – Lean Considerations Inventory - all components, work-in-process and
finished product not being processed 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)
Again an MRP system is used to minimize excess inventory
Waiting - waiting for the next production step (a type of WIP)
Overproduction - production ahead of demand (can be WIP or finished goods)
ISPE-CCPIE CHINA CONFERENCE 2010
Case Study – Confidential Client, Southern China
Project Approach – Lean Considerations Motion - people or equipment moving or walking more
than is required to perform the processing Managed in the design process by improving
adjacencies Over Processing - resulting from poor tool or product
design creating activity Includes effort expended producing better quality
than required to meet specifications Managed in the design process by specifying
appropriate processes, equipment and systems Defects - the effort involved in inspecting for and fixing
defects
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Impact Assessment
• 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.” • 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. • 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.
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Impact Assessment
• Considering…• Operation• Control• Alarm• Failure
• To assign impact on product quality as either • Direct• Indirect• No Impact
• Evaluating Systems including• Process• Process Support• Utility & Facility• Miscellaneous
Step-1: Impact Assessment
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Impact Assessment
• Direct Impact Systems• Process Equipment• Critical Utilities
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Impact Assessment
• Indirect Impact Systems• Air-Handlers• Utility Systems
• No Impact• General
Heating/Cooling• Office / Lab Equipment• Waste Treatment
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Impact Assessment
• For direct impact systems• Identify critical components
• Assign validation requirements• Commissioning all systems: Direct, Indirect, None• Qualification for systems w/Impact: Direct & Indirect• PQ: Direct Impact Systems
ISPE-CCPIE CHINA CONFERENCE 2010
• Built Upon Equipment List
Quality by Design - Impact Assessment
ISPE-CCPIE CHINA CONFERENCE 2010
• The Value of the Impact Assessment • Defines limit of full validation (usually less than 100%)• Defines subjects of risk analysis (usually critical systems or
components only)• Documents validation requirements and their basis
Quality by Design - Impact Assessment
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Risk Analysis
• Underlying Documents• ICH Q8• ICH Q9• ASTM E2500-07• Impact Assessment
• Analysis Objectives• Focus on direct impact components • Correlate risk directly to product
integrity or patient health• Establish or vindicate design
requirements
Step-2: Risk Analysis
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Risk Analysis
• Risk Methodology• Modified FMECA (Failure Mode, Effects and Criticality Analysis) Method
• Risk = Severity x Frequency x Anticipation
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Risk Analysis
• Severity is Science-Based• Design space sets operating
limits
• Critical process parameters affect quality
• Consequences of straying outside design space
• Quality effects on patient health
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Risk Analysis
• Frequency is Engineering-Based• F – Value = Frequency of
Failure
• Influences equipment selection
ISPE-CCPIE CHINA CONFERENCE 2010
• Anticipation is Engineering-Based• A – Value = Anticipation of
Failure
• Influences control selection
• F x A, Not S, is Engineering-Based
Quality by Design - Risk Analysis
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Risk Analysis
• Worksheet aids analysis• One for each direct impact system record of
• Selected critical process parameters• Design spaces• Consequences on product quality severities
• Recommends• Allowable F-Values• Allowable A-Values
• Direct results• No prioritization required
• Work within allowable F - & A - Values
ISPE-CCPIE CHINA CONFERENCE 2010
Quality by Design - Risk Analysis
• Value of the risk analysis • Early identification of design requirements
• Minimizes over-design• Minimize re-work due to under-design
ISPE-CCPIE CHINA CONFERENCE 2010
Summary
• For all New Facilities and Major Renovations:• Manufacturers must consider the benefits of designing a facility
to meet Global Regulatory Expectations (SFDA, FDA, EMEA)• And the potential Savings afforded by QbD, Lean and a Risk
Based Approach to Validation.
ISPE-CCPIE CHINA CONFERENCE 2010
About The Presenter
• Brian White 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.
• About CDI - 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.
• About MWP – 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.