GMP Vendor Audits

A complete GMP vendor audit program — covering audit planning, on-site and virtual audit execution, finding classification, and closure, built for sponsors managing outsourced manufacturing and testing.

Who it's for: Virtual sponsors responsible for auditing CMOs, CROs, and other GMP vendors, with or without an internal audit team.

What's included:

• Annual Audit Plan development and audit frequency requirements (minimum every 3 years)
• Full audit procedure: preparation, opening meeting, on-site/virtual execution, and close-out meeting
• Finding classification system (Critical, Major, Minor) and CAPA follow-up expectations
• Audit reporting requirements and required report elements
• Audit closure and tracking procedures

Format: Fully editable Word document (.docx).

Regulatory alignment: References FDA 21 CFR Parts 210 and 211.