cGMP Quality Oversight and Signature Authority for Quality Agreements Policy

University Policy

Title

University of North Carolina at Chapel Hill Policy on cGMP Quality Oversight and Signature Authority for Quality Agreements

Introduction

Purpose

To define the authority of the Clinical Research Compliance Office (CRCO) in:

  • Determining whether current Good Manufacturing Practices (cGMP) requirements apply to a given project or activity;
  • Overseeing cGMP compliance in all applicable scenarios;
  • Exercising signature authority for Quality Agreements and similar research agreements related to quality expectations and regulatory compliance pertaining to cGMP activities.

Scope

This Policy applies to all University employees involved in any activity potentially subject to cGMP, including but not limited to manufacturing, testing, packaging, storage, and distribution.

Policy

Policy Statement

All Covered Individuals are required to engage CRCO early in the project lifecycle to confirm cGMP applicability and maintain compliance. If cGMP applies in connection with a project, the CRCO must review, and the Covered Individual must receive approval from the CRCO regarding implementation of cGMP processes prior to proceeding with the project.

All Quality Agreements or similar research agreements related to quality expectations and regulatory compliance pertaining to cGMP activities must undergo CRCO review and approval. Only individuals duly authorized by the Office of the Vice Chancellor for Research may sign such agreements.

Consequences for Policy Violations                                          

Failure to follow this policy may result in unauthorized agreements, regulatory non-compliance, and project delays. The CRCO may suspend or modify project activities to address compliance risks. Violations will be reviewed in accordance with applicable policy and procedures and may result in corrective actions or disciplinary measures up to and including termination.

Definitions

cGMP – Current Good Manufacturing Practices – regulations and guidelines intended to ensure the consistent production and control of products to quality standards appropriate for their intended use and as required by the U.S. Food and Drug Administration (FDA).

Covered Individuals - University employees who are engaged in, or whose responsibilities include, any activity that may be subject to current Good Manufacturing Practices (cGMP).

Quality Agreement – a formal written agreement that defines the roles and responsibilities of each party involved in cGMP-related activities, including manufacturing, testing, and distribution.

Related Requirements

External Regulations

University Policies, Standards, and Procedures

Contact Information

Primary Contact

Name: Jamie Kauwell, Interim Director

Unit: Clinical Research Compliance

Email: clinrescomp@unc.edu

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