SOP-18: Responsibility and Organization of Operational and Quality Areas defines how your company structures, manages, and oversees responsibilities across operational and quality functions — especially when activities are outsourced. It ensures alignment between internal leadership, QA, QP, and contracted partners to maintain product quality, patient safety, and regulatory compliance.
 
This SOP is professionally written and pre-filled (~95% complete), requiring only company-specific details before approval.
Developed for virtual, lean, or fully outsourced pharmaceutical models, the template outlines roles for General Management, QA, the Qualified Person (QP), Operations Outsourcing Lead, and all external partners involved in GMP/GDP activities such as manufacturing, testing, warehousing, and distribution.
 
Includes:
• Organisational structure for outsourced operations
• Responsibilities of internal leadership, QA, and QP
• Oversight of manufacturing, QC, warehousing, and distribution partners
• Requirements for Quality Agreements
• Governance of communication, escalation, and decision-making authority
 
Why it matters:
Clear responsibility distribution is essential in outsourced pharmaceutical setups. This SOP ensures your company maintains full regulatory accountability while enabling efficient collaboration with GMP/GDP service providers — a critical requirement during audits and inspections.