Manufacturing in the Global Pharmaceuticals Industry

Key drivers, company strategies and regulations

Publication Date	April 2003
Publisher	URCH Publishing
Product Type	Report
Pages
ISBN Number	954112148
Product Code	URC00003

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Summary

The range of alternatives open to a company to manufacture their product portfolio is growing all the time. Before selecting a way forward the alternatives should be the subject of rigorous technical and financial examination. Manufacturing in the Global Pharmaceuticals Industry - Key drivers, company strategies and regulations, will help executives make the right decisions for their companies.

This unique 50,000 word report, from leading information provider Urch Publishing, will help you to:

Weigh 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
Effectively develop strategies to manage contract manufacturer relationships
Demonstrate how extra investment in validation will improve performance

The report also tackles the more practical aspects of manufacturing with a review of the main dosage forms being produced and their related technologies. There is a discussion on the relative merits of green field sites versus refurbishment. The growing topic of validation is dealt with in great detail, as this is an area of significant expenditure, often misunderstood by senior management; this section concludes with a presentation of both the costs and benefits of validation.
This report will also serve as a reference text for companies in the emerging markets who are starting out on the journey towards international standards of quality in manufacturing.

Content

1. Key Issues Facing the Pharmaceuticals Industry
2. Manufacturing Versus Sales Of Pharmaceuticals - Worldwide & Western Europe
- World market
- Western Europe
- Austria
- Belgium
- Denmark
- Finland
- France
- Germany
- Greece
- Ireland
- Italy
- Netherlands
- Norway
- Portugal
- Spain
- Sweden
- Switzerland
- UK
- Japan
3. Manufacturing Versus Sales Of Pharmaceuticals - Central & Eastern Europe & The Former Soviet Union
- Czech Republic
- Kazakhstan
- Poland
- Russia
- Slovenia
- Turkey
- Ukraine
4. Manufacturing Versus Sales Of Pharmaceuticals - The Americas
- North America
- Canada
- United States
- Latin America
- Argentina
- Brazil
- Central America and the Dominican Republic
- Chile
- Colombia
- Mexico
- Peru
- Puerto Rico
- Venezuela
5. Manufacturing Versus Sales Of Pharmaceuticals - The Rest Of The World
- Africa
- Morocco
- Nigeria
- South Africa
- Zimbabwe
- Australasia
- Far East
- China
- Singapore
- India
- Middle East
- Saudi Arabia
- Egypt
- Jordan
- Yemen
6. Strategic Options For Pharmaceutical Manufacture
- In-house manufacture
- Global or strategic sites
- Regional sites
- Local sites
- Summary
- Partnerships
- Joint ventures
- Contracting out
- Outsourcing
- Licensing out
- Selling off - the product
- Selling off - the company
- Buying in - 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
7. The Impact Of E-Commerce
- Product registration
- Manufacturing information sources
- Purchasing
- Documentation control
- Sales and marketing
- Electronic communities
- Conclusion
8. Outsourcing
- Why outsource?
- Financial reasons
- Reasons of timing
- Reasons of resource
- Organisational reasons
- Outsourcing providers (the contract takers)
- Prerequisites for successful outsourcing
- The outsourcing provider
- The outsourcing user
- The contract
- Conclusion
9. Key Issues Facing Manufacturing
- Drivers for manufacturing strategy
- Current manufacturing base
- Product portfolio
- Capacity
- Registration
- Source of raw materials and packaging materials Internal factors
- Quality of the product
- Cost of goods
- Timeliness of supply
- Incoming quality of materials
- Productivity
- Yield
- Sales forecast
- 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
- Environmental issues
- Climate
- Disaster management
- Biotechnology manufacturing
- Lack of capacity
- Lack of awareness
- Lack of investment
- Conclusion
10. Quality Management
- 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
- Good Manufacturing Practice guidelines and enforcement around the world
- The US
- Western Europe
- The Pacific Rim
- Latin America
- Central and eastern Europe and the Former Soviet Union
- Poland
- Ukraine
- Russia
- Central Asian republics
- Middle East and Africa
- Asia
- The role of the World Health Organization
- WHO codes and guidelines
- GMP and the multinationals
- Harmonisation of standards
- PIC/s
- Mutual recognition between Europe and North America
- Mutual recognition between Europe and other countries
- ICH
- Other harmonisation programmes
- Conclusion
11. Certification Of Factories To Gmp Compliance
- Determining the appropriate standard
- Factory inspection - the FDA approach
- Pre-approval inspections
- Follow-up inspections
- Routine inspections
- WHO certification scheme
- Training of inspectors
- ISO 9000
- Quality Systems Inspection Technique
- Conclusion
12. Designing And Building A Manufacturing Facility
- Introduction
- Obtaining the correct environmental standards
- Classification systems
- Product types, dosage forms and related technologies
- General comments
- Dry products
- Semi-solid products
- Liquid products
- 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
- Trends in facility design
- Introduction
- Horizontal 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
13. Validation In Pharmaceuticals Manufacturing
- Definitions
- Design qualification
- Installation qualification
- Operational qualification
- Performance qualification
- Process validation
- Design qualification
- Production of the URs
- Validation master plan
- Project design brief
- Family tree
- Design qualification checklist
- Formal design qualification review
- Installation qualification
- Determining validation requirements
- Carrying out and completing installation qualification
- Operational qualification
- Determining validation requirements
- Carrying out and completing operational qualification
- Performance qualification
- Performance testing
- Health and safety review
- Training records
- Pilot production
- Process validation
- Retrospective validation
- Cleaning validation
- Analytical validation
- The cost of validation
- The benefits of validation
- Example of the benefit of a fully integrated validation programme
- Conclusion
14. The Future For Pharmaceutical Manufacturing
- Trends
- Demography
- 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
Bibliography And Sources
Abbreviations
List of Tables
- Table 1.1 Worldwide leading pharmaceutical companies
- Table 1.2 Cumulative market share of 50 pharmaceutical companies 1989, 1997 and 1999
- Table 1.3 Leading therapy classes by global pharmaceutical sales, 2001
- Table 1.4 Leading products by global pharmaceutical sales, 2001
- Table 1.5 The fall in market exclusivity over time
- Table 1.6 R&D spend by the 10 leading companies, 2000
- Table 2.1 World market growth, 1991-2001
- Table 2.2 Global pharmaceutical sales by market 2001
- Table 2.3 Top 10 markets for pharmaceuticals in 1999
- Table 2.4 International pharmaceutical trade in western Europe
- Table 2.5 Belgium - manufacturing and sales, 1996-9 ($bn)
- Table 2.6 Domestic sales versus imports in France
- Table 2.7 Domestic sales versus exports in France
- Table 2.8 Changes in French market size, 1996-2001
- Table 2.9 Changes in German market size, 1996-2001
- Table 2.10 Changes in Italian market size, 1996-2000
- Table 2.11 Changes in Spanish market size, 1996-2000
- Table 2.12 Changes in UK market size, 1996-9
- Table 3.1 Russian pharmaceutical market 1997-2005
- Table 6.1 Advantages and disadvantages of options for pharmaceutical manufacturing
- Table 9.1 Summary of key manufacturing issues facing pharmaceutical companies
- Table 12.1 Facility construction costs
- Table 12.2 Air classification system for manufacture of sterile products
- Table 12.3 Comparison of classes of environmental standards
- Table 12.4 Area classifications for sterile production
- Table 12.5 Cost elements in a construction project
- Table 12.6 Typical URS questionnaire
- Table 13.1 Comparison of validation terminology
- Table 13.1 Resource investment in validation
- Table 13.2 Benefits of validation
List of Figures
- Figure 12.1 Horizontal flow I
- Figure 12.2 Horizontal flow II
- Figure 12.3 Vertical flow