Working with a Contract Manufacturer: Key Considerations - After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a pro

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Working with a Contract Manufacturer: Key Considerations
After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider, and preparing quality agreements.


BioPharm International Supplements


References

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2. Standard & Poor's. Industry Surveys, Healthcare: Pharmaceuticals Industry Survey. New York: Standard & Poor's. 2006 May 25, p. 4

3. Express Scripts. Generic Drugs Slow Rise in Prescription Drug Costs, Saving $5.2 Billion in 2007. 2008 Feb 29 Available from: phx.corporate-ir.net/phoenix.zhtml?c=69641&p=irol-newsArticle&ID=1113936&highlight.

4. Richardson ER. Partnering with complementary companies for more efficient drug development. Amer Pharm Outsourcing. 2003 Nov/Dec;4(6):8–17.

5. Zaret EH. It's all about communication. Amer Pharm Outsourcing. 2002 Jan/Feb;3(1): 30–34.

6. Blasini R. Quality agreements in pharmaceutical/biopharmaceutical outsourcing. Amer Pharm Outsourcing. 2006 Sept/Oct;7(5):30–37.

7. Rosenkrantz D. Quality considerations for managing contract service providers. Amer Pharm Outsourcing. 2002 May/June;3(3):20–25.

8. Hedgecock V. Preparing for pre-approval inspections at contract manufacturers. Amer Pharm Outsourcing. 2002 Nov/Dec; 3(6); 28–35.

9. Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding, 21 CFR Chapter 1, Subchapter C. (1979). Available from http://www.fda.gov/cder/dmpq/preamble.txt

10. Langer ES. Biomanufacturing Capacity Flat in 2006. Contract Pharma. 2006 Nov/Dec, p. 36.

11. Roth G. 2007 Annual Outsourcing Survey. Contract Pharma. 2007 May. Available from: http:// http://contractpharma.com/articles/2007/05/2007-annual-outsourcing-survey>as of 3/15/08

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