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Reportlinker Adds Pharmaceutical Contract Manufacturing: Industry and Market Prospects 2010-2025

egulatory Considerations in Outsourced Manufacturing

3.2 Summary of GMP Requirements

3.3 Compliance with FDA Provisions is Vital

3.4 EU Regulations and the Qualified Person Role

3.5 Q7A Guidance for Active Pharmaceutical Ingredient (API) and Excipient Production

3.6 Harmonisation of GMP Standards

3.7 EU API Makers for Good Manufacturing Practices Inspections

3.8 Enforcing cGMP Compliance for APIs in EU

3.9 EU Requirements for Outsourcing Services

3.10 Good Manufacturing Practice (GMP) Compliance

3.11 API Requirements Challenge Outsourcing Services from China

3.12 Summary: Globalisation Benefits Pharma Harmonisation

4. The Outsourcing Decision

4.1 Reasons to Outsource

4.1.1 Outsourcing as a Tactical Decision

4.1.2 Outsourcing as a Strategic Decision

4.2 Cost-Benefit Analysis of Outsourcing

4.3 Risks Associated with Outsourcing Incur Hidden Costs

4.3.1 Errors and Delays Can Cost Millions

4.3.2 Regulatory Compliance Must be Assured

4.3.3 IP and Other Sensitive Data May be at Risk

4.3.4 Management of Outsourcing Requires Continued Monitoring

4.4 Technology Transfer Considerations

4.5 The Virtual Company

4.5.1 'Virtuality' Helps Control Rising Costs

4.5.2 Strong Project and Operations Management is Vital

4.5.3 The Challenges of Virtual Companies are Relevant Across the Industry

4.6 Key Requirements for Successful Outsourcing

4.6.1 Trust and Accountability

4.7 Summary: Planning the Guiding Principle for Outsourcing

5. Pharma Contract Manufacturing Industry and Market 2010-2025

5.1 The World Contract Manufacturing Market in 2010

5.2 Growing Market for Contract Manufacturing Services

5.2.1 Revenue Forecast for Total Pharma Contract Manufacturing Market, 2010-2016

5.2.2 Revenue Forecast for Total Pharma Contract Manufacturing Market, 2017-20

SOURCE Reportlinker
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