cGMP Cleaning Supplies from VWR International for Pharmacy Department (Notice of Intent to sole source)
Closed Pre-Solicitation Posted
- Solicitation number
- NOI-CC-25-010512
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325998 All Other Miscellaneous Chemical Product and Preparation Manufacturing
- Place of performance
- Bethesda, Maryland 20814, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Clinical Center is issuing a Notice of Intent to procure cGMP cleaning supplies from VWR International through sole source negotiation. The requirement encompasses specialized contamination control cleaning supplies for NIH biologics manufacturing sites and aseptic processing areas at Building 10 on the Bethesda, Maryland campus. Critical contract requirements include provision of Certificates of Analysis, Certificates of Conformance, and Packing Inserts with each packaged case of supplies to ensure compliance with Joint Commission and FDA certifications for cGMP pharmaceutical development practices. The justification states that VWR International is uniquely positioned as the only company capable of providing the required Certificate of Acceptance, Certificate of Compliance, packing slip documentation, and website access with their specialized tracking system. This pre-solicitation notice was posted on September 16, 2025, with a due date of September 19, 2025, providing interested parties a brief three-day window to respond.
This procurement does not utilize any set-aside designations and identifies VWR International as both the intended sole source contractor and apparent incumbent provider. The Bill of Materials specifies seven different product types including DECON-AHOL 70% trigger spray, Vesphene III and LPH III disinfectants, bucket liners, mops, and sterile wipers across multiple case quantities. The cleaning supplies are essential for supporting the NIH Clinical Center's MMESD Storage & Distribution Section in maintaining GMP standards for laboratory, research, and medical facilities. No specific contract value or budget range is disclosed in the notice, though the specialized nature of these cGMP-compliant supplies suggests a significant procurement investment. The timeline emphasizes immediate need, as these supplies are critical for ongoing pharmaceutical development operations and regulatory compliance maintenance.
Notice text
Acquisition Description:
This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with VWR International.
cGMP Cleaning Supplies from VWR International for Pharmacy Department
The National Institute of Health (NIH)’s MMESD, Storage & Distribution Section has a requirement for contamination control cleaning supplies for NIH biologics manufacturing sites and aseptic processing areas at the NIH CC (Bldg. 10) on the Bethesda, MD campus. It is vital that the Contractor provides Certificates for Analysis (COA), Certificates of Conformance and Packing Inserts in each packaged case of supplies. The requirement is to obtain cleaning supplies for the NIH, Clinical Center pharmacy departments. It is critical to adequately clean these rooms with the needed Government approved cleaning supplies to be able to pass the Joint Commission and FDA Certifications for cGMP pharmaceutical development practices.
Justification:
The NIH Clinical Center MMESD, Storage & Distribution Section is the sponsoring institution at the National Institutes of Health responsible for providing medical/surgical and cleaning supplies in support of the GMP. These GMP Cleaning Supplies plays a pivotal role in direct support of GMP and patient care. It is critical to adequately clean the NIH’s laboratory, research, medical etc. rooms with the needed Government approved cleaning supplies to be able to pass the Joint Commission and FDA Certifications for cGMP pharmaceutical development practices. Program Management states VWR International is the only company that can provide the requested Certificate of Acceptance (COA), Certificate of Compliance (COC), Packing Slip and website access. VWR items comply with Joint Commission and FDA Certifications for cGMP, and VWR products have certificates and a unique VWR tracking system that confirms their products are suitable to be used in laboratory clean rooms.
Requirement:
Pharmacy cGMP Cleaning Supplies.
See Bill of Materials.
Place of Performance or Delivery:
The Period of Performance is: 09/19/2025 – 09/18/2026
Delivery within 30 days.
Place of Performance: NIH Clinical Center in Bethesda, MD
The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-25-010512) by 09:00 AM eastern standard time on 09/19/2025 to: lu-chang.lu@nih.gov
All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.
Files
| File | Type | Posted |
|---|---|---|
| 1. Bill of Materials.docx | DOCX document |
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