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