SOP: Release of Products with Marketing Authorisation Manufactured at CMO

This SOP: Release of Products with Marketing Authorisation Manufactured at CMO describes the full, GMP-compliant process for batch release when manufacturing is outsourced to a Contract Manufacturing Organization (CMO). It outlines the Qualified Person’s (QP) responsibilities, documentation requirements, release criteria, and oversight obligations to ensure each batch meets GMP, Marketing Authorisation and specification standards before entering the market.
 
This SOP is professionally written and pre-filled (~95% complete), requiring only company-specific details before approval.
Developed for virtual, outsourced, or lean pharmaceutical companies, the template covers QP qualification, CMO oversight, documentation review, batch certification, and quarantine/release status requirements. It reflects EU GMP Volume 4, Annex 13, Annex 16, and regulatory expectations for QP certification.
 
Includes:
• QP responsibilities and regulatory requirements
• Release criteria and required documentation (CoA, CoC, MA compliance, deviations)
• Oversight of CMOs and supply chain traceability
• Quarantine, release and rejection definitions
• Batch Release Certificate structure (Annex 13 content)
• Requirements for maintaining batch registers
 
Why it matters:
Batch release is one of the most scrutinised GMP processes. This SOP ensures your organisation meets all QP obligations, maintains regulatory compliance, and demonstrates full control over outsourced manufacturing operations.