Standard Operating Procedure for Product Monitoring in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for monitoring the quality and consistency of ocular dosage forms, including eye drops, ointments, gels, and inserts, throughout the manufacturing process.

2) Scope

This SOP applies to all stages of production for ocular dosage forms within the pharmaceutical manufacturing facility, ensuring compliance with quality standards and regulatory requirements.

3) Responsibilities

QA Department: Responsible for reviewing and approving product monitoring records and reports.
Production Department: Responsible for conducting product monitoring activities during manufacturing.
Operators: Responsible for performing product checks and recording data as per the SOP.
Laboratory Technicians: Responsible for conducting quality control tests on product samples.

4) Procedure

4.1 Routine Product Monitoring

1. Establish a monitoring schedule for all stages of production for ocular dosage forms.
2. Conduct routine inspections and tests on in-process and finished products as per the schedule.
3. Document all observations, test results, and any deviations in the product monitoring log.

4.2 Monitoring Parameters

1. Identify key quality attributes to be monitored for each ocular dosage form, such as pH, viscosity, sterility, and content uniformity.
2. Use calibrated instruments and validated methods to measure these parameters accurately.

4.3 Corrective Actions

1. Document any deviations or issues observed during monitoring in the product 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 Sampling and Testing

1. Collect samples of in-process and finished products as per the sampling plan.
2. Perform quality control tests on samples, including physical, chemical, and microbiological tests.
3. Document test results and compare them against established specifications.

4.5 Documentation

1. Maintain a product monitoring log for each batch of ocular dosage forms, documenting all inspections, tests, and corrective actions.
2. Prepare product monitoring reports summarizing the data and any corrective actions taken.
3. Submit product monitoring reports to QA for review and approval.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

1. Product Monitoring Logs
2. Product Quality Control Test Records
3. Product 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