SOP for Operation, Calibration, and Verification of Disintegration Test Apparatus
STANDARD OPERATING PROCEDURE Operation, Calibration, and Verification of Disintegration Test Apparatus 1.0 Purpose To define a standardized procedure for operation, calibration, and verification of the disintegration test apparatus to ensure reproducible and pharmacopoeial-compliant disintegration times of tablets and capsules as per IP, BP, USP <701>, and EP 2.9.1. 2.0 Scope Applicable to all disintegration test apparatus used in the Quality Control Laboratory for solid oral dosage forms. 3.0 Responsibility Designation Responsibility QC Analyst Perform operation, sample preparation, calibration, verification, and record data QC Supervisor Review and verification of results and calibration records QC Manager Approval and overall compliance with pharmacopoeia Engineering Preventive maintenance, servicing, and troubleshooting 4.0 References Indian Pharmacopoeia (IP) British Pharmacopoeia (BP) USP <701> Disintegration Europea...