Standard Operating Procedure for Personnel Monitoring in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a procedure for monitoring personnel involved in the manufacturing of ocular dosage forms, such as eye drops, ointments, gels, and inserts, to ensure compliance with hygiene and contamination control standards.

2) Scope

This SOP applies to all personnel working in the ocular dosage form manufacturing areas, including clean rooms and aseptic processing areas, to maintain product quality and regulatory compliance.

3) Responsibilities

QA Department: Responsible for reviewing and approving personnel monitoring data and reports.
Microbiology Laboratory: Responsible for analyzing personnel monitoring samples.
Production Department: Responsible for ensuring personnel adhere to hygiene and gowning procedures.
Personnel: Responsible for complying with hygiene and gowning requirements and participating in monitoring activities.

4) Procedure

4.1 Personnel Hygiene and Gowning

1. Ensure all personnel are trained on proper hygiene and gowning procedures.
2. Provide appropriate gowning materials, including gloves, masks, hairnets, and sterile garments.
3. Verify that personnel follow hand washing and sanitization procedures before entering controlled areas.

4.2 Monitoring Procedure

1. Conduct routine personnel monitoring to assess compliance with hygiene and gowning standards.
2. Perform contact plate sampling on hands, gloves, and gowns of personnel at regular intervals.
3. Document sampling activities in personnel monitoring logs.

4.3 Analysis

1. Transport collected samples to the microbiology laboratory for analysis within specified time frames.
2. Incubate microbial samples under appropriate conditions to detect and quantify microbial contamination.

4.4 Documentation

1. Document all test results, observations, and deviations in the personnel monitoring records.
2. Prepare personnel monitoring reports summarizing the data and any corrective actions taken.

4.5 Review and Approval

1. Submit personnel monitoring reports to QA for review and approval.
2. Implement corrective actions for any deviations or non-compliances identified during monitoring.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

1. Personnel Monitoring Logs
2. Personnel 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