Temperature Deviation Request Form

TEMPERATURE DEVIATION REQUEST FORM

Parties and Identification

Client Name:

Recitals

WHEREAS, the Requesting Party is responsible for storage, handling and distribution of temperature-sensitive product(s) at the Facility identified above; and

WHEREAS, a deviation from the established temperature control limits has occurred or is anticipated and the Requesting Party seeks formal authorization to document, investigate and approve corrective and preventive actions in accordance with applicable quality procedures; and

WHEREAS, the Parties intend to document the scope, risk assessment, required actions, approval and any contractual or payment implications arising from the temperature deviation.

Deviation Details

Production / Receipt Date:

Observed Temperature (start):    Time:

Observed Temperature (end):    Time:

Scope of Work

Scope: The Parties agree that the scope of work for this deviation comprises the investigation, containment, disposition decision, implementation of CAPA and documentation required to reach a disposition consistent with quality and safety requirements. The Requesting Party will perform the investigation and the Approving Party will review and render a disposition decision as set forth below.

Risk Assessment

Product Impact (select all that apply):

Product loss or compromised potency    Potential patient safety impact    Shelf-life / expiry impact    No material impact identified

Payment Terms

Where deviation handling requires charges to be allocated or additional services procured, the Parties agree as follows.

Late Fee: If invoiced amounts are not paid within days of invoice, a late fee of per month will accrue on the unpaid balance.

Term and Termination

This agreement governing the deviation review and remedial services commences on and shall continue until unless earlier terminated in accordance with this section.

Either Party may terminate this agreement for convenience by providing written notice at least days prior to the effective termination date. Termination shall not relieve either Party of obligations accrued prior to the effective termination date, including payment obligations.

Confidentiality

Each Party agrees to maintain as confidential all non-public information disclosed in connection with this deviation request, including investigation findings, risk assessments, test results and CAPA details, and to use such information solely for purposes of addressing the deviation. Disclosure is permitted only to the extent required by law or regulatory authority and then only after prior written notice to the disclosing Party where legally permissible.

Governing Law

This Request and any resulting agreement or disposition shall be governed by and construed in accordance with the laws of the state specified below, without regard to its conflict of laws rules.

Entire Agreement

This document, including its attachments and any disposition instructions duly executed by the Parties, constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior discussions, negotiations and understandings, whether oral or written. Any amendment must be in writing and executed by authorized representatives of both Parties.

Approvals and Disposition

Approver Title:    Date:

Acknowledgement

By submitting this Temperature Deviation Request Form, the Requesting Party certifies that the information provided is true and complete to the best of their knowledge, and that they will cooperate with the Approver and any testing laboratories to facilitate a timely disposition. The Parties acknowledge that disposition decisions may require additional documentation, sampling, testing, and cost allocation as set forth above.

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