SOP: Quality Agreement for Drug Product Manufactured at CMO

This Quality Agreement for Drug Product Manufactured at CMO defines the GMP responsibilities, quality activities, and compliance obligations between a product owner (BUYER) and a Contract Manufacturing Organization (CMO). It ensures regulatory alignment, product quality, and clear accountability throughout outsourced manufacturing operations in accordance with EU GMP, WHO GMP, and applicable regulatory requirements.
Quality agreement for drug prod…
The document is professionally written and pre-filled (~95% complete), requiring only company-specific details before execution.
Developed for biotech and pharmaceutical companies outsourcing manufacturing, testing, packaging, and storage, the agreement clearly defines responsibilities for deviations, change control, batch release, complaints, recalls, audits, and regulatory inspections.
 
Includes:
• GMP responsibility split between BUYER and SUPPLIER (CMO).
• Oversight of manufacturing, packaging, testing, and storage
• Batch release and Qualified Person (QP) requirements
• Deviation, OOS, CAPA, complaint, and recall management
• Change control and regulatory communication
• Audit rights and inspection handling
• Detailed responsibility matrix and structured appendices
 
Why it matters:
A robust Quality Agreement is a regulatory requirement when outsourcing GMP activities. This template ensures inspection-ready documentation, clear governance, and effective quality oversight of CMO operations.