IQ/OQ/PQ Qualification and Validation Services

The contract seeks qualified small businesses to perform Installation, Operational, and Performance Qualification (IQ/OQ/PQ) services to validate that systems meet the stringent compliance requirements of FDA 21 CFR Part 610, which governs the standards for biological products. The work involves rigorous documentation and testing procedures to ensure that equipment and processes function correctly, consistently, and in alignment with regulatory expectations for safety, efficacy, and quality control in biologics manufacturing. All activities must be conducted in accordance with current Good Manufacturing Practices and documented to support FDA inspection readiness. This is a Total Small Business Set-Aside under NAICS code 541380, reserved exclusively for small businesses as defined by the SBA, and is solicited by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services. The contract is to be performed at a designated location in Silver Spring, Maryland, with a response deadline of July 31, 2026. The nature of the work requires specialized expertise in regulatory validation, with an emphasis on adherence to federal biologics standards and comprehensive recordkeeping to demonstrate conformity and traceability throughout the qualification lifecycle.