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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...

STANDARD OPERATING PROCEDURE Operation and Calibration of Conductivity Meter 1.0 Purpose To describe the standardized procedure for operation, calibration, and verification of the conductivity meter using USP conductivity buffer solutions to ensure accurate measurement of conductivity in pharmaceutical samples in accordance with USP <645>. 2.0 Scope This SOP applies to all conductivity meters used in the Quality Control Laboratory for analysis of aqueous solutions, raw materials, and finished pharmaceutical products. 3.0 Responsibility Designation Responsibility QC Analyst Operation, calibration, verification, and documentation QC Supervisor Review and verification of results QC Manager Overall compliance and approval Engineering Maintenance and servicing 4.0 Accountability The QC Manager is accountable for implementation and compliance with this SOP. 5.0 References USP <645> Conductivity Indian Pharmacopoeia British ...

STANDARD OPERATING PROCEDURE Operation and Calibration of pH Meter 1.0 Purpose To describe the standardized procedure for operation, calibration, and verification of the pH meter using USP buffer solutions to ensure accurate pH measurement in accordance with USP <791>, IP, BP, and EP. 2.0 Scope This SOP applies to all pH meters used in the Quality Control Laboratory for analysis of raw materials, intermediates, and finished pharmaceutical products. 3.0 Responsibility Designation Responsibility QC Analyst Operation, calibration, verification, slope check, and documentation QC Supervisor Review and verification of results QC Manager Overall compliance and approval Engineering Maintenance and servicing 4.0 Accountability The QC Manager is accountable for implementation and compliance with this SOP. 5.0 References USP <791> pH Indian Pharmacopoeia British Pharmacopoeia European Pharmacopoeia 2.2.3 pH Meter Manufacture...

STANDARD OPERATING PROCEDURE Operation and Calibration of Refractometer 1.0 Purpose To describe the procedure for operation, calibration, and verification of the refractometer to ensure accurate determination of refractive index in accordance with IP, BP, USP <831>, and EP 2.2.6. 2.0 Scope This SOP applies to all refractometers used in the Quality Control Laboratory for testing of raw materials, intermediates, and finished pharmaceutical products. 3.0 Responsibility Designation Responsibility QC Analyst Operation, calibration, testing, and documentation QC Supervisor Review and verification of results QC Manager Overall compliance and approval Engineering Maintenance and servicing 4.0 Accountability The QC Manager shall be accountable for implementation and compliance of this SOP. 5.0 References Indian Pharmacopoeia British Pharmacopoeia USP <831> Refractive Index European Pharmacopoeia 2.2.6 Refractometer Manufac...

STANDARD OPERATING PROCEDURE Operation and Calibration of Polarimeter 1.0 Purpose To establish a detailed procedure for the operation, calibration, verification, and routine performance check of the polarimeter to ensure accurate and reproducible measurement of optical rotation in accordance with IP, BP, USP <781>, and EP 2.2.7. 2.0 Scope This SOP is applicable to all polarimeters installed in the Quality Control Laboratory used for analysis of raw materials, intermediates, and finished pharmaceutical products. 3.0 Responsibility Designation Responsibility QC Analyst Instrument operation, solution preparation, calibration, recording data QC Supervisor Review and verification of results QC Manager Approval and compliance with pharmacopoeia Engineering Preventive maintenance and servicing 4.0 References Indian Pharmacopoeia British Pharmacopoeia USP <781> Optical Rotation European Pharmacopoeia 2.2.7 Polarimeter Manufactu...