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