全球藥品產業的製造動向：主要促進因素、企業策略及規範（第3版）

全球藥品產業的製造動向：主要促進因素、企業策略及規範（第3版） 是由出版商Urch Publishing, Ltd.在2008年09月所出版的。 這份英文市場調查報告書包含135 pages 價格從美金1365起跳。

簡介

目錄

Abstract

The new edition of this best-selling report offers insight into the manufacturing process, strategy, issues and drivers from an expert author.

Manufacturing in the Global Pharmaceuticals Industry - Key drivers, company strategies and regulations (3rd ed) is the only report available that covers this crucial area of the pharmaceutical industry in such depth. The concentration in recent years on creating organisations that are market or customer-led, or research-driven has taken the focus away from the manufacturing process, although it is clear that the most successful organisations integrate all these activities to remain market leaders.

Global pharmaceutical manufacturing is in a state of flux. There is excess capacity in manufacturing facilities for finished dosage forms and a shortfall for biotechnology manufacturing. The situation in APIs is not so clear-cut, and the trend for multinationals to grow through M & A has led to the need to rationalise facilities. Meanwhile, local companies from emerging markets wishing to expand into new markets and exporting must be able to satisfy ever more stringent quality standards.

This report tackles the challenges of manufacturing in a global marketplace by providing unique insight into the strategies a successful company will adopt. By using examples, case studies and scenarios to aid clarification of the more technical aspects of the manufacturing process, you can be assured your desisions are made with full understanding of the key issues.

This timely third edition will enable you to:

• Assess the pros and cons of outsourcing manufacturing functions and develop key strategies to effectively measure supplier and contractor performance
• Understand and prepare for the latest regulations applicable to manufacturing and their variations globally
• Develop strategies to effectively manage contractor relationships
• Understand the definitions used in validation, and how extra investment in validation will improve performance
• Build competencies for manufacturing that meet the objectives of: speed of delivery, reduction in product cost, overall quality, optimisation of capital spend, maintenance of customer inventory, minimisation of regulatory impact, optimisation in the number of manfacturing sites, maintenance of strategic sourcing for disaster management planning
• Understand the ' New Paradigm' in international manufacturing and how it relates to the pharmaceutical industry.

Use this report help with:

• Planning a global manfacturing strategy
• Regulations and quality assurance issues
• The ' New Paradigm' in manufacturing
• The key drivers and changes in today' s manufacturing environment
• Making the right investment decision

Table of Contents

Executive Summary

Chapter 1: Key Issues Facing the Pharmaceutical Industry

• Structure of the industry
• Global product portfolio
• Pressures
• Structure
• Customers
• Market exclusivity
• Price and operating margins
• The need to change the way the industry works
• Shorter development times
• Focus on key customer areas
• Improve collaboration between functions
• Learn from other industries
• Historical development of manufacturing
• 1960s and 1970s
• 1980s
• 1990s and 2000s
• Conclusion

Chapter 2: Pharmaceutical Manufacturing versus Sales Worldwide, in Europe and in Japan

• World market
• Western Europe
• Austria
• Belgium
• Czech Republic
• Denmark
• Finland
• France
• Germany
• Greece
• Ireland
• Italy
• The Netherlands
• Norway
• Poland
• Portugal
• Slovenia
• Spain
• Sweden
• Switzerland
• The UK
• Japan

Chapter 3: Pharmaceutical Manufacturing versus Sales in Central and Eastern Europe

• Armenia
• Georgia
• Kazakhstan
• Russia
• Turkey
• Ukraine

Chapter 4: Pharmaceutical Manufacturing versus Sales in the Americas

• North America
• Canada
• The US
• Latin America
• Argentina
• Brazil
• Central America and the Dominican Republic
• Chile
• Colombia
• Mexico
• Peru
• Puerto Rico
• Venezuela

Chapter 5: Pharmaceutical Manufacturing versus Sales in the Rest of the World

• Africa
• Morocco
• Nigeria
• South Africa
• Zimbabwe
• Australasia
• Australia
• New Zealand
• Far East
• China
• Singapore
• India
• Middle East
• Saudi Arabia
• Egypt
• Jordan

Chapter 6: Strategic Options for Pharmaceutical Manufacture

• In-house manufacture
• Global or strategic sites
• Regional sites
• Local sites
• The best approach
• Partnerships
• Joint ventures
• Contracting out
• Outsourcing
• Licensing out
• Selling off the product
• Selling off the company
• Acquisitions
• Strategic options for companies in emerging markets
• Internal resourcing
• External resourcing
• Collaboration with the multinationals
• Acquisition by the multinationals
• Facility for rent
• Conclusion

Chapter 7: The Impact of e-Business on the Pharmaceutical Industry

• Product registration
• Manufacturing information sources
• Purchasing
• Documentation control
• Sales and marketing
• Electronic communities
• Conclusion

Chapter 8: Outsourcing Pharmaceutical Manufacturing

• Why outsource?
• Financial reasons
• Timing reasons
• Resource reasons
• Organisational reasons
• Outsourcing providers (the contract takers)
• Prerequisites for successful outsourcing
• The outsourcing provider
• The outsourcing user
• The contract
• Researching the outsourcing market
• Outsourcing market
• Research targets
• Levels of outsourcing
• Why outsource?
• Choosing a contract acceptor
• Conclusion

Chapter 9: Key Issues Facing Pharmaceutical Manufacturing

• Drivers for manufacturing strategy
• Current manufacturing base
• Product portfolio
• Capacity
• Registrations
• Source of raw materials and packaging materials
• Internal factors
• Quality of the product
• Cost of goods
• Timeliness of supply
• Quality of incoming materials
• Productivity
• Yield
• Sales forecasts
• Relationship with R&D and marketing
• Technology
• Available personnel
• Formulations
• Level of decision making
• Summary
• Economic factors
• Cost of manufacture
• Cost of transport
• Capital expenditure
• Running costs
• Closing plants
• Tax advantages
• Economies of scale versus flexibility
• Exit costs versus re-entry costs
• Political factors
• Stability of the country
• Influence on prices
• Influence on product licences
• Trade barriers
• Geographical factors
• Demography - portfolio versus the marketplace
• Importance of the market
• Regional groupings
• Regulatory factors
• Climate
• Environmental issues
• Disaster management
• Biotechnology manufacturing
• Lack of capacity
• Lack of awareness
• Lack of investment
• Conclusion

Chapter 10: Quality Management in Pharmaceutical Manufacturing

• Quality assurance
• Good manufacturing practice
• Defined processes
• Validated processes
• Suitable facilities
• Clear instructions/procedures
• Trained operators
• Full and accurate records
• Batch traceability
• Quality maintained during distribution
• Complaints procedure
• Recall procedure
• Quality control
• Electronic records and electronic signatures
• GMP for starting materials
• GMP guidelines and enforcement around the world
• The US
• Western Europe
• Pacific Rim
• Australia
• Japan
• Latin America
• Central and Eastern Europe and the Former Soviet Union (FSU)
• Central Asian Republics and the Caucasus
• New EU Member States
• Russia
• Ukraine
• Middle East and Africa
• Israel
• Jordan
• Nigeria
• Saudi Arabia
• South Africa
• Yemen
• Zimbabwe
• Asia
• China
• India
• Singapore
• The role of the World Health Organization
• WHO codes and guidelines
• GMP and the multinationals
• Harmonisation of standards
• PIC/S
• Mutual recognition between the EU and North America
• Mutual recognition between the EU and third countries
• ICH
• Regional harmonisation initiatives
• PANDRH
• COMESA
• Other harmonisation programmes
• Conclusion

Chapter 11: Certification of Factories to GMP Compliance

• Determining the appropriate standard
• Factory inspection - the Food and Drug
• Administration (FDA) approach
• Pre-approval inspections
• Follow-up inspections
• Routine inspections
• WHO certification scheme
• Training of inspectors
• WHO prequalification scheme
• ISO 9000
• Quality Systems Inspection Technique
• Conclusion

Chapter 12: Designing and Building a Manufacturing Facility

• Obtaining the correct environmental standards
• Classification systems
• Product types, dosage forms and related technologies
• General comments
• Dry products
• Tablets
• Capsules
• Powders
• Environmental requirements
• Semi-solid products
• Ointments
• Creams
• Environmental requirements
• Liquid products
• Manufacture and filling
• Environmental requirements
• Sterile products
• Environmental requirements
• Methods of sterilisation
• High-potency products
• Antibiotics
• Biopharmaceutical products
• Packaging
• Types of packaging
• Batch identification
• Environmental requirements
• Other dosage forms and technologies
• API manufacturing
• Trends in facility design
• Introduction
• Horizontal flow
• Vertical flow
• Lights-out operation
• Volume versus flexibility
• Basic Minimum Standard versus Best Practice
• Greenfield site development versus refurbishment
• Getting the design right from the start
• Conclusion

Chapter 13: Validation in Manufacturing

• Definitions
• Design qualification
• Installation qualification
• Operational qualification
• Performance qualification
• Process validation
• Design qualification
• Production of the URS
• Validation master plan (VMP)
• Project design brief
• Family tree
• Design qualification checklist
• Formal DQ review
• Installation qualification
• Determining validation requirements
• Carrying out and completing the IQ
• Operational qualification
• Determining validation requirements
• Carrying out and completing OQ
• Performance qualification
• Performance testing
• Health & safety review
• Training records
• Pilot production
• Process validation
• Retrospective validation
• Cleaning validation
• Analytical validation
• Validation - a cost-benefit analysis
• The cost of validation
• The benefits of validation
• Examples of the benefits of validation
• Prospective validation of process equipment
• Retrospective validation of a steriliser
• Retrospective validation of cleaning validation
• Conclusion

Chapter 14: The New Paradigm

• Twenty-first-century pharmaceutical manufacturing
• New terminology
• Quality risk management (QRM)
• Quality by design (QbD)
• Design space
• Process analytical technology (PAT)
• Parametric release
• Putting it all together
• ICH and the ' New Paradigm'
• ICH Q8 Pharmaceutical Development
• ICH Q9 Quality Risk Management
• ICH Q10 Pharmaceutical Quality System
• Mandatory versus optional activities

Chapter 15: The Future for Pharmaceutical Manufacturing

• Trends
• Demography
• Changing medical needs
• Changing science and technology
• Increasing cost pressures
• Future of the multinationals
• Reduction in excess capacity
• Improvement in national quality standards
• Harmonisation
• Global GMP certificate
• The shape of the manufacturing industry
• Conclusion
• Glossary
• Bibliography and Sources

LIST OF FIGURES

• Figure 12.1 Horizontal flow I
• Figure 12.2 Horizontal flow II
• Figure 12.3 Vertical flow

LIST OF TABLES

• Table 1.1 Worldwide leading pharmaceutical companies
• Table 1.2 Cumulative market share of 50 pharmaceutical companies, 1989, 1999 and 2007
• Table 1.3 Leading therapy classes by global pharmaceutical sales, 2007
• Table 1.4 Leading products by global pharmaceutical sales, 2007 (2001)
• Table 1.5 The fall in market exclusivity over time
• Table 1.6 R&D spend by the 10 leading companies, 2006
• Table 2.1 World market growth, 2000-2007
• Table 2.2 Global pharmaceutical sales by market, 2001
• Table 2.3 Global pharmaceutical sales by market, 2007
• Table 2.4 Top 10 markets for retail sales, March 2007-February 2008
• Table 2.5 International pharmaceutical trade in Western Europe, 2006 ($bn)
• Table 2.6 Austria - pharmaceutical trade balance ($bn)
• Table 2.7 Domestic sales versus imports in France
• Table 2.8 Domestic sales versus exports in France
• Table 2.9 Changes in the size of the French market in recent years
• Table 2.10 Changes in German pharmaceutical sales ($bn)
• Table 2.11 Trade balance in pharmaceuticals, Greece ($bn)
• Table 2.12 Changes in the Irish export market in recent years
• Table 2.13 Trade balance in pharmaceuticals, the Netherlands ($bn)
• Table 2.14 Changes in the Japanese share of the global market
• Table 2.15 Changes in Japanese trade
• Table 3.1 Estimated pharmaceutical market, Russia and FSU countries, 2004
• Table 3.2 Pharmaceutical market, Kazakhstan ($m)
• Table 3.3 Pharmaceutical market, Russia, 1997-2005
• Table 3.4 Pharmaceutical market, Turkey, 1997-2007
• Table 3.5 Ukrainian pharmaceutical suppliers
• Table 4.1 Share of global pharmaceutical sales, North America
• Table 4.2 The US market as a percentage of global pharmaceutical sales
• Table 4.3 The Argentinean market by value and volume
• Table 4.4 Argentinean trade in pharmaceuticals ($m)
• Table 4.5 Argentinean production versus imports ($bn)
• Table 5.1 Market growth, China, 1991-2007
• Table 5.2 Market growth, selected markets, 2003-2007
• Table 6.1 Advantages and disadvantages of options for pharmaceutical manufacturing
• Table 9.1 Summary of key manufacturing issues facing pharmaceutical companies in general
• Table 12.1 Facility construction costs in Western Europe
• Table 12.2 Air classification system for the manufacture of sterile products
• Table 12.3 Comparison of classes of environmental standards
• Table 12.4 ISO 14644 Cleanrooms and Associated Controlled Environments
• Table 12.5 Area classifications for sterile production
• Table 12.6 Cost elements in a construction project
• Table 12.7 Typical URS questionnaire
• Table 13.1 Comparison of validation terminology
• Table 13.2 Resource investment in validation
• Table 13.3 Benefits of validation

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