SOP-16: Inspections from Authorities and Partners defines how your company prepares for, manages, and follows up on inspections conducted by health authorities or external partners. It provides a clear, compliant process for communication, documentation, coordination, and corrective actions, ensuring full alignment with GMP/GDP expectations.
 
This SOP is professionally written and pre-filled (~95% complete), requiring only company-specific details before approval.
Developed by QA specialists with real inspection experience, the template outlines responsibilities for the Quality Manager, operational personnel, and contractors — covering both onsite inspections and those occurring at GMP/GDP service providers.
 
Includes:
• Procedures for announced inspections
• Responsibilities during opening & closing meetings
• Documentation handling and note-taking requirements
• Guidance for responding to inspector questions
• Follow-up, deviation handling, and corrective actions
• Oversight of inspections at contractors
 
Why it matters:
Effective inspection management is essential for maintaining regulatory trust and avoiding compliance issues. This pre-filled SOP ensures your organisation handles inspections professionally, consistently, and in accordance with regulatory expectations.