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

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.