SOLICITATION NOTICE
H -- cGMP Compliance Audit of Operations
- Notice Date
- 9/10/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-NCI-20155-NV
- Point of Contact
- Deborah Moore, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, - David Keefer, Contracting Officer, Phone (301) 435-3801, Fax (301) 480-0309,
- E-Mail Address
-
dm170b@nih.gov, dk63h@nih.gov
- Description
- The National Cancer Institute proposes to enter into a sole source purchase order with Phoenix Imperative Inc., of Frederick, MD 21704, to perform a Current Good Manufacturing Practice (cGMP) compliance audit of the NCI-SAIC Biopharmaceutical Development Program (BDP) at the Frederick Cancer Research and Development Center (FCRDC). The NCI Biological Resources Branch (BRB) is supported by the BDP who provides research, development and cGMP production of biologics for cancer treatment and other diseases. BRP is responsible for the oversight of the BDP, including ensuring that the facility and its programs remain in compliance with the Food and Drug Administration?s regulations governing such programs. These compliance audits fulfill regulatory obligations to determine the laboratory?s level of compliance with Federal regulations and cGMP and satisfies, in part, BRP?s oversight responsibility. Phoenix Imperative Inc. (PII) has reviewed the BDP on two separate occasions, October 1999 and April 2000. They have made several recommendations and suggestions for improvement of the BDP functions and it is essential to have an assessment of the present status of the BDP with specific comparison to those previous findings. In addition, due to their previous involvement and reviews with the BDP, PII has gained an excellent base of knowledge of the programs and research of BDP and BRP which will facilitate a quick and efficient review of the program. The final report for the audit will be required NLT 3 weeks after issuance of the order. This notice of intent is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The capability statement and any information must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can fully meet this requirement. An original and one copy of the Capability Statements must be received in the contracting office by 1:00 PM EDT (local Washington, D.C. time) on September 19, 2002. All questions must be in writing and can be faxed to (301) 402-4513 or emailed to dm170b@nih.gov . It is the vendors responsibility to call (301) 402-4509 to insure questions have been received. A determination by the Government not to compete this requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted.
- Record
- SN00162167-W 20020912/020910213247 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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