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Article: The quality agreement: Compliance considerations in selecting a contract manufacturer
- Article from:
- Biopharm International
- Article date:
- February 1, 2001
- Author:
CopyrightCopyright Advanstar Communications, Inc. Feb 2001. Provided by ProQuest LLC. (Hide copyright information)
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Outsourcing does not absolve the "virtual" company of responsibility for OMP compliance. This business model may save money in the short term (especially if a product eventually falls in clinical trials), but it can present difficulties of Its own. Whether a company is looking for Its first contract manufacturer or moving to a new one, written plans and agreements are key to achieving the goals of both parties involved.
People who are most concerned with financial matters love the concept of outsourcing. It allows a company to enter clinical trials quickly, without the staggering cost of building a plant. Contract manufacturers usually have great expertise in process sciences, analytical ...