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Quality Assurance and Batch Release Testing

Active
Federal

Contract Overview

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This contract involves independent quality assurance testing of AMYVID batches, focusing on ensuring radiochemical purity, sterility, endotoxin levels, and accurate dose calibration. The testing is required to confirm compliance with current Good Manufacturing Practices (cGMP) and FDA standards, thereby ensuring the safety and effectiveness of the product before release. The work is set as a subcontract under the Department of Veterans Affairs, specifically managed by the 242-NETWORK Contract Office 02 (36C242). The contract falls under the NAICS code 541380, which pertains to testing laboratories, indicating the specialized nature of the services requested. Although specific details about the place of performance or point of contact are not provided, the contract posting date is May 26, 2026. The overall purpose is to maintain strict regulatory adherence and quality standards through rigorous testing protocols, supporting the safe distribution and use of AMYVID in clinical and medical settings.

General Info

Independent quality assurance testing of AMYVID for cGMP, FDA compliance under VA subcontract.

NAICS

541380 - Testing Laboratories and Services

Place of Performance

NY

Set-Aside

NONE

Documents

This scope was carved out of 36C24226Q0580.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

6505--AMYVID RADIOPHARMACEUTICAL CONTRACT

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Timeline

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subcontract

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 242-NETWORK Contract Office 02 (36C242)
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Independent testing of AMYVID batches for radiochemical purity, sterility, endotoxins, and dose calibration to ensure cGMP and FDA compliance.

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