Pharmaceutical Marketing and Promotional Materials Compliance Audit Checklist

These audits should be conducted at least bi-annually, with more frequent reviews for new product launches or significant marketing campaign changes. Additionally, spot checks should be performed regularly on ongoing promotional activities.

This checklist covers review of promotional material content, assessment of fair balance in product information, evaluation of off-label promotion risks, compliance in healthcare professional interactions, social media and digital marketing practices, and regulatory approval processes for promotional materials.

These audits are typically conducted by regulatory affairs specialists, medical affairs professionals, legal compliance officers, or qualified marketing compliance auditors with expertise in pharmaceutical marketing regulations.

The checklist ensures that all marketing and promotional activities adhere to regulatory guidelines, including accurate product claims, proper disclosure of risk information, and compliance with regulations like the FDA's fair balance requirements and global codes of practice.

If non-compliant materials or practices are identified, actions should include immediate withdrawal or correction of the materials, investigation of the approval process breakdown, retraining of relevant personnel, review of similar materials for potential issues, and implementation of enhanced review processes. All actions must be documented and reported to management.