SOURCES SOUGHT
R -- cGMP/GLP Site Visits and Audits
- Notice Date
- 5/5/2006
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Program Support Center, Division of Acquisition Management, Parklawn Building Room 5-101 5600 Fishers Lane, Rockville, MD, 20857
- ZIP Code
- 20857
- Solicitation Number
- Reference-Number-RFI-ORDC-PAJ-001
- Response Due
- 5/31/2006
- Archive Date
- 10/31/2006
- Description
- The Office of Research and Development Coordination (ORDC) within the Department of Health and Human Services through the Program Support Center, Strategic Acquisition Service is soliciting capability statements to perform Pre-award site reviews. Vaccines, Drugs, Bio-Therapeutics and Diagnostics are manufactured using many physical operations to bring together components, containers and closures into a product that is ready for use. Activities found in these firms can be organized into systems that are sets of operations and related activities. Control of all systems helps to ensure the firm will produce medical countermeasures that are safe, have the identity and strength, and meet the quality and purity characteristics as required by the FDA. These site visits and audits will be required to cover of 2 or more systems, with mandatory coverage of the Quality System (see system definitions below). The visits or audits options include different numbers of systems to be covered depending on whether it is a visit or audit. The site visit/audit report generated from inspecting the minimum number of systems, or more systems as deemed necessary by the visit/audit team, will provide the basis for an overall cGMP/GLP status decision. The attached document provides the basis for any proposed solicitation that will be issued in the future. Please review this document and provide written input or comments to William.Hummer@hhs.gov by May 31, 2006. If your firm has capability in this area, please provide a capability statement to William.Hummer@hhs.gov by May 31, 2006. The ORDC contact person for this project is William Hummer. No decision has been made on whether a solicitation will be issued or the manner of any future procurement for this requirement.
- Record
- SN01042651-W 20060507/060505221548 (fbodaily.com)
- Source
-
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