The Center for Tobacco Products (CTP) Tobacco Products
Laboratory (TPL) requires a preventative maintenance agreement and operational qualification for two Agilent **** HPLC/UHPLC instruments. The period of performance is one year, from 07/01/2025 to 06/30/2026, Monday through Friday, excluding federal holidays. The contractor must provide at least one preventative maintenance inspection visit per instrument per 12-month period, scheduled by the technical point of contact (TPOC) at least seven business days in advance. The service must comply with manufacturer specifications and local quality assurance standards (ISO ****). The contractor must provide unlimited telephone and email access to instrument technical support, a minimum of two service calls per year, and documentation of all performed maintenance and repair activities. The contractor must provide qualification service after planned PM and repairs, including operation qualification/performance verification (OQ/PV). The service must be performed onsite at the FDA, or at the new location (**** Hardee Ave, Atlanta, GA ****) if applicable. The contractor is responsible for all packaging, shipping, and transportation costs for offsite repairs. The contractor must provide documentation of temperature verification, calibrations, and instrument performance runs. If a system fails a test during qualification service, the contractor must provide onsite service to remedy the failure and reexecute the qualification service. The contractor must provide a field service report/ticket for each service call, including equipment details, reason for the service call, work performed, test instruments used, technician information, onsite hours, and parts replaced. Monthly reports summarizing all maintenance and repair activities, including warranty work, must be provided to the FDA project
officer and contract specialist by the 5th workday of the following month.