Provision Language
Section B: General Terms and Conditions
30) Manufacturing Standards: The Managing Entity requires Portfolio Company to comply with cGMP guidelines (21 CFR Parts 210-211, 600) for manufacturing, processing and packing of drugs, chemicals, biological, and reagents. The Managing Entity requires Portfolio Company to advise the HHS OTAO and OTAR immediately of any relocation of their prime manufacturing facility or the relocation of any performance site’s facility. Managing Entity requires Portfolio Company to advise the HHS OTAO’s and Contracting Officer’s Representative immediately if at any time during the life of the contract, the items under this contract fail to comply with cGMP guidelines and/or the facility receives a negative FDA Quality Assurance Evaluation (Form 483).
Attachment 4: Reporting Requirements
Clinical Reporting Requirements
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FDA or EMA Audits
In the event of an FDA or EMA inspection which occurs that relates to products under this Agreement, or for any other FDA or EMA inspection that has the reasonable potential to impact the performance of this Agreement, Portfolio Company shall provide CARB-X with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR) (or the corresponding forms from the EMA). Portfolio Company shall provide CARB-X with copies of the plan for addressing areas of non-conformance to FDA or EMA regulations for GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plan’s execution and a copy of all final responses to the FDA or EMA.
a. Portfolio Company shall notify CARB-X within 5 business days of a scheduled FDA or EMA audit or within 12 hours of an ad hoc site visit/audit if the FDA or EMA does not provide advanced notice.
b. Portfolio Company shall provide copies of any FDA or EMA audit report received from sub-recipients that occur as a result of this agreement or for products funded hereunder within three (3) business days of receiving correspondence from the FDA or EMA.
c. Within five (5) business days of audit report, Portfolio Company shall provide CARB-X with a plan for addressing areas of nonconformance, if any are identified.
d. For the purposes of this Attachment, “EMA” includes all constituent national drug regulatory authorities.
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Non-Routine Reports and Notifications
The section below includes non-routine (Ad hoc) reporting requirements. These reports are event driven and are due contingent upon such events occurring. All reports should be submitted to the CARB-X Chief of R&D and Alliance Lead (see Attachment 3A). Additional report recipients are as indicated below.
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QA Audits and Reports
Managing Entity reserves the right to participate in QA audits at the Portfolio Company. Upon completion of the audit/site visit the Portfolio Company shall provide a report capturing the findings, results and next steps in proceeding. If action is requested of the Portfolio Company, detailed concerns for addressing areas of non-conformance to FDA or EMA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to Managing Entity. The Portfolio Company shall provide responses from the site to address these concerns and plans for corrective action execution.