Standard Operating Procedure for Process Monitoring in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for monitoring the manufacturing processes of ocular dosage forms, including eye drops, ointments, gels, and inserts, to ensure product quality and regulatory compliance.

2) Scope

This SOP applies to all manufacturing processes involved in the production of ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

QA Department: Responsible for reviewing and approving process monitoring records and reports.
Production Department: Responsible for conducting routine monitoring of manufacturing processes.
Operators: Responsible for performing process checks and recording data as per the SOP.
Maintenance Department: Responsible for ensuring equipment used in the processes is maintained and functioning correctly.

4) Procedure

4.1 Routine Process Monitoring

1. Establish a monitoring schedule for all critical processes involved in the manufacturing of ocular dosage forms.
2. Conduct routine inspections and performance checks as per the schedule.
3. Document all observations, measurements, and any deviations in the process monitoring log.

4.2 Monitoring Parameters

1. Identify key parameters to be monitored for each manufacturing process, such as temperature, mixing time, pH, and viscosity.
2. Use calibrated instruments to measure these parameters accurately.

4.3 Corrective Actions

1. Document any deviations or issues observed during monitoring in the process monitoring log.
2. Report deviations to the production and QA departments 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 a process monitoring log for each critical process, documenting all inspections, measurements, and maintenance activities.
2. Prepare process monitoring reports summarizing the data and any corrective actions taken.
3. Submit process monitoring reports to QA for review and approval.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

1. Process Monitoring Logs
2. Process Calibration Records
3. Process Maintenance Records
4. Process 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