🔍 SOP for Internal Audit / Self-Inspection This Standard Operating Procedure (SOP) outlines the process for conducting Internal Audits and Self-Inspections in laboratories, QA/QC, R&D, and production areas. It ensures compliance with GLP/GMP regulations, ICH Q10, and internal SOPs, covering audit planning, execution, reporting, CAPA implementation, and continuous improvement of quality systems. 1. Introduction Internal Audit, also known as Self-Inspection, is a systematic, independent, and documented process used to verify compliance with approved SOPs, GLP/GMP requirements, and regulatory guidelines. Internal audits help identify weaknesses, non-conformances, and improvement opportunities before regulatory inspections. An effective internal audit system strengthens quality culture, ensures data integrity, and supports continuous improvement. 2. Purpose To define a structured and controlled process for planning, conducting, reporting, and followi...
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Self-Inspection SOP
Audit Procedure SOP