Department Of Health And Human Services, Program Support Center, Supply Service Center, Perry Point, MD 21902

H -- VALIDATION AND QUALIFICATION SERVICES SOL RFP 284-R-99-0001 DUE 011499 POC Deborah G. McCavitt, Contract Specialist, (410) 642-6023 VALIDATION AND QUALIFICATION SERVICES: Perform validation and qualification services for all existing equipment and processes for FDA licensed pharmaceutical repackaging facility at Department of Health and Human Services, Program Support Center, Supply Service Center, Perry Point, Maryland. Services will be for Phase I to include Cleaning Validation, Label Generation/Verification System Validation and Compressed Air Validation of the Pharmacy Section. Contract will also contain an option for Phase II for Installation Qualification(IQ), Operation Qualification(OQ), and Process Qualification(PQ for all Pharmacy machinery, and an option for Phase III for IQ, OQ and PQ for Heating, Ventilation and Air Conditioning(HVAC) systems. Services will include, but are not limited to, providing assurance for compliance with all Federal(FDA) guidelines and Current Good Manufacturing Practices(CGMP); writing and/or revising SOP's; developing flow charts and/or documentation to facilitate implementation and consistence compliance to assure all processes have proper supporting documents in place; determining overall safety, quality and cost effectiveness of the repackaging process; and qualification against defined requirements and specifications of facilities systems and equipment. Issue Date for RFP 284-R-99-0001 is December 2, 1998. A site visit for all prospective offerors is scheduled for December 9, 1998, 10:00 AM (EST). Offers must be received by COB (4:30 PM, EST) on January 14, 1999. No telephonic requests will be accepted. Written requests for solicitation may be addressed to Contracting Officer, PSC, HHS Supply Service Center, Bldg. 14, Perry Point, MD 21902 or faxed to (410) 641-3566. Posted 11/16/98 (W-SN271697). (0320)

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