SOP for Operation, Calibration, and Verification of Dissolution Test Apparatus
STANDARD OPERATING PROCEDURE Operation, Calibration, and Verification of Dissolution Test Apparatus 1.0 Purpose To establish a harmonized and standardized procedure for operation, physical (mechanical) calibration, chemical calibration (Performance Verification Test), and verification of the dissolution test apparatus to ensure accurate, reproducible, and pharmacopoeial-compliant dissolution testing as per IP, BP, USP <711>, and EP 2.9.3. 2.0 Scope This SOP is applicable to all dissolution test apparatus (USP Apparatus I – Basket and USP Apparatus II – Paddle) used in the Quality Control Laboratory for testing tablets and capsules. 3.0 Responsibility Designation Responsibility QC Analyst Operation, calibration, PVT execution, testing, and documentation QC Supervisor Review of calibration, PVT, and test results QC Manager Approval and compliance with IP/BP/USP/EP Engineering Preventive maintenance and servicing 4.0 References Indian ...