SOW_RFQ-NIAID-24-2210099.pdf

RFQ-NIAID-24-2210099

STATEMENT OF WORK

1) BACKGROUND INFORMATION

The National Institutes of Health (NIH), National Institute of Allergy and Infectious Disease (NIAID), Vaccine Immunology Program (VIP) aids the Vaccine Research Center (VRC) by supporting the development of monoclonal antibodies and vaccines for infectious diseases such as HIV, Influenza, Ebola, and more recently SARS-CoV-2 Coronavirus. Support is through the state-of-the-art laboratory performing pre- clinical as well as Phase 1 and Phase 3 clinical end point testing to inform further study designs, research questions and vaccine modification and design. To be compliant with FDA guidelines for phase 3 testing, the VIP must maintain CFR 21-part 11 compliance, which includes the inspection of the facilities, processes and testing methods to be considered Good Clinical Laboratory Practice (GCLP) compliant.

The VIP has a current requirement for inspection services for GCLP compliance and certification. Current certification expires Ql 2024. The objective is to renew the lab’s compliance certificate.

2) PURPOSE AND OBJECTIVES OF THE ACQUISITION

This acquisition aims to provide inspection and audit of Guidelines on Good Clinical Laboratory Practice (GCLP) areas, procedures, equipment and training records for compliance and certificate.

The current requirements are as follows:

# DESCRIPTION QTY

1 GCLP Compliance Inspection & Certification 1

3) REQUIREMENTS:

The following workflow is required for high GCLP compliance Laboratories.

1. Consultant Remote preparations for the on-site audit:

o Preparation call with the Laboratory to align the audit scope o Familiarization with the company current operations o Preparation of a detailed draft Agenda describing the scope of the audit and how this will be achieved, reference standards, date and time of the audit conduct o Request for comments/approval by the Laboratory to the Agenda o Finalization of Agenda, issue and distribution as agreed o Gain access to required electronic systems for document review o Review the site Standard Operating Procedures (SOP) updated list/index o Travel arrangements (including COVID requirements, if any); transportation, accommodation

2. Audit conduct includes:

o Opening meeting with agreed parties, confirmation of the scope and agenda o Facility tour o Review of documents o Interviews with key site staff identified on the agenda to cover audit scope and answer questions noted during preparation and conduct phase Audit will cover (as relevant):

o Program information, organization and facility o Receipt, handling and storage of samples o Equipment qualification, calibration and maintenance o Analysis Procedures / Methods o Organization and Personnel o Quality Management (Policies and procedures) o SOP management o Study Management o Computerized Systems; Backup and recovery, including server room o Archive and procedures (paper/electric, as relevant) o Study specific procedures and raw data review, if required o Debriefing including communication of findings and comments to agreed site staff

3. Post audit activities include:

o Writing of Draft Audit Report o Distribution of Draft Audit Report to nominated person(s) o Address Laboratory comments/questions o Finalization of the Audit Report o Provide ‘CAPA Template’ for the Laboratory response o Review of CAPAs suggested by the Laboratory and provide feedback o When all CAPA closed/agreed, provide ‘GCLP Compliance Certificate’ valid for two years

4) CONTRACTOR SUPPLIED MATERIALS

The Contractor shall provide all necessary parts and equipment necessary to perform inspection and certification.

5) GOVERNMENT FURNISHED MATERIALS

No Government-furnished materials are provided under this contract.

6) REPORTING REQUIREMENTS AND DELIVERABLES

o Writing of Draft Audit Report o Distribution of Draft Audit Report to nominated person(s) o Address Laboratory comments/questions o Finalization of the Audit Report o Provide ‘CAPA Template’ for the Laboratory response o Review of CAPAs suggested by the Laboratory and provide feedback

7) INSPECTION AND ACCEPTANCE

a) All work will be inspected and approved by the VIP, or designee at the completion of any repairs and at the completion of the annual maintenance.