Standard Operating Procedure for Equipment Monitoring in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a systematic procedure for monitoring equipment used in the manufacturing of ocular dosage forms, such as eye drops, ointments, gels, and inserts, to ensure consistent performance and compliance with regulatory standards.

2) Scope

This SOP applies to all equipment used in the production, storage, and handling of ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

QA Department: Responsible for the review and approval of monitoring records and reports.
Maintenance Department: Responsible for conducting routine monitoring and maintenance of equipment.
Production Department: Responsible for reporting any equipment issues or deviations.
Operators: Responsible for daily checks and proper usage of equipment as per SOPs.

4) Procedure

4.1 Routine Equipment Monitoring

1. Establish a monitoring schedule for all critical equipment used in the manufacturing process.
2. Conduct routine inspections and performance checks as per the schedule.
3. Document all observations, measurements, and any deviations in the equipment monitoring log.

4.2 Monitoring Parameters

1. Identify key parameters to be monitored for each piece of equipment, such as temperature, pressure, and operational hours.
2. Use calibrated instruments to measure these parameters accurately.

4.3 Corrective Actions

1. Document any deviations or issues observed during monitoring in the equipment monitoring log.
2. Report deviations to the maintenance department for immediate corrective action.
3. Record all corrective actions taken and verify the effectiveness of the corrective measures.

4.4 Calibration and Maintenance

1. Ensure all monitoring instruments and equipment are calibrated as per the calibration schedule.
2. Perform routine maintenance on equipment to ensure optimal performance and compliance.
3. Maintain records of all calibration and maintenance activities.

4.5 Documentation

1. Maintain an equipment monitoring log for each piece of equipment, documenting all inspections, measurements, and maintenance activities.
2. Prepare equipment monitoring reports summarizing the data and any corrective actions taken.
3. Submit equipment monitoring reports to QA for review and approval.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

1. Equipment Monitoring Logs
2. Equipment Calibration Records
3. Equipment Maintenance Records
4. Equipment Monitoring Reports

7) Reference, if any

Good Manufacturing Practices (GMP) guidelines
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

8) SOP Version

Version 1.0