Quality management system for a virtual/non-integrated biotechnology company seeking regulatory approval -- Dissertation

Sign Up Sign In

Biohealthmatics Centers

Home

Jobs Search

Career Center

Networking Center

Company Profiles

Knowledge Center

Industry News

Web Directory

Industry Books

Quality management system for a virtual/non-integrated biotechnology company seeking regulatory approval -- Dissertation

by Beverly R., Wilson

Publisher: ProQuest / UMI
Publication Date: Tuesday, October 31, 2006
Number of Pages: 44
ISBN: 0542017342

Book Summary:
The quality system regulation as described in Part 211 of Title 21 of the Code of Federal Regulations and other guidance and regulatory documents provide the information necessary for an integrated company to determine how to assure the quality, purity, safety and effectiveness of their product. A virtual, non-integrated organization manufacturing through contract manufacturing and seeking to develop their quality system may find that these same documents are deficient. They may be lacking in the detail necessary to ensure an effective quality management system that relies on the quality system of contract manufacturing organizations. The standard operating procedure that has been developed as a result of this project is designed to provide a quality management system that will assure that the quality system of the sponsor is aligned and integrated with the quality system of the contract manufacturing operations that support the sponsor\'s product.

Book Reviews

Post a book review for this title

No reviews for this title. Be the first to post a review.

More Biotechnology Books

More Biotechnology Books ...

Can't find what you are looking for? View our Site Map

Last Updated: 24 November 2007.