Standard Operating Procedure for Quality Monitoring in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to outline the procedures for ensuring consistent quality monitoring of ocular dosage forms, including eye drops, ointments, gels, and inserts, during the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the production and quality assurance of ocular dosage forms within the pharmaceutical manufacturing facility, covering all stages from raw material receipt to final product release.

3) Responsibilities

Quality Assurance (QA) Department: Responsible for overseeing the quality monitoring process, reviewing records, and ensuring compliance with regulatory requirements.
Production Department: Responsible for implementing quality monitoring procedures during manufacturing.
Operators: Responsible for performing quality checks and recording data as per this SOP.
Quality Control (QC) Laboratory: Responsible for conducting quality tests on product samples.

4) Procedure

4.1 Establishing Quality Monitoring Parameters

1. Identify critical quality attributes (CQAs) for each ocular dosage form, such as sterility, pH, viscosity, particle size, and active ingredient concentration.
2. Determine acceptable ranges and specifications for each CQA based on regulatory guidelines and product requirements.

4.2 Routine Quality Monitoring

1. Conduct routine quality checks at predefined stages of the manufacturing process, including raw material inspection, in-process monitoring, and final product testing.
2. Use validated methods and calibrated instruments for all quality checks to ensure accuracy and reliability.
3. Document all observations, test results, and any deviations in the quality monitoring log.

4.3 Sampling and Testing

1. Collect samples at specified stages of production as per the sampling plan.
2. Perform physical, chemical, and microbiological tests on samples to ensure they meet established specifications.
3. Record test results and compare them against acceptance criteria.

4.4 Deviation Management

1. Document any deviations observed during quality monitoring in the deviation log.
2. Report deviations to the QA department for investigation and corrective action.
3. Implement corrective actions and document their effectiveness in resolving the deviation.

4.5 Documentation and Reporting

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

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
CQA: Critical Quality Attributes

6) Documents, if any

1. Quality Monitoring Logs
2. Quality Control Test Records
3. Deviation Logs
4. Quality Monitoring Reports

7) Reference, if any

Good Manufacturing Practices (GMP) guidelines
ICH Q10: Pharmaceutical Quality System
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

8) SOP Version

Version 1.0