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

ADVERTISEMENT

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

1. Reymond E. Contract manufacturing biz to exceed $26bn. http://Outsourcing-Pharma.com/, 2006 Oct 30. Available from: http://www.outsourcing-pharma.com/news/ng.asp?id=71680.

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

12. Barnes K. New webcam gives Cook competitive edge. Outsourcing Pharma. 2005 Nov 11. Available from http://www.outsourcing-pharma.com/news/ng.asp?id=63801.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

UPS' Pain in the Supply Chain Results
September 23, 2014
Merck KGaA Announces Acquisition of Sigma-Aldrich for $17 Billion
September 22, 2014
Pandemic Vaccine Facility Dedicated in Texas
September 19, 2014
GSK Fined in China Bribery Scandal
September 19, 2014
Guideline Delineates How to Implement GS1 Standards to Support DSCSA
September 19, 2014
Author Guidelines
Source: BioPharm International Supplements,
Click here