Standard Operating Procedure for Environmental Monitoring in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to outline the procedure for monitoring the environmental conditions in manufacturing areas to ensure compliance with regulatory standards and maintain the quality of ocular dosage forms, such as eye drops, ointments, gels, and inserts.

2) Scope

This SOP applies to all controlled environments within the ocular dosage form manufacturing facility, including clean rooms, aseptic processing areas, and other controlled environments.

3) Responsibilities

QA Department: Responsible for reviewing and approving environmental monitoring data and reports.
Microbiology Laboratory: Responsible for conducting environmental monitoring tests and analyzing samples.
Production Department: Responsible for maintaining the cleanliness and environmental conditions of manufacturing areas.
Facility Management: Responsible for the maintenance and calibration of environmental monitoring equipment.

4) Procedure

4.1 Environmental Monitoring Plan

1. Develop an environmental monitoring plan outlining sampling locations, frequency, and methods.
2. Identify critical monitoring parameters, including particulate counts, microbial counts, temperature, and humidity.
3. Ensure all personnel involved in environmental monitoring are trained on the procedures.

4.2 Sampling

1. Perform air sampling using active air samplers and passive settle plates at designated locations and frequencies.
2. Conduct surface sampling using contact plates or swabs on critical surfaces and equipment.
3. Monitor temperature and humidity using calibrated sensors or data loggers.
4. Document all sampling activities in environmental 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.
3. Analyze particulate counts using calibrated particle counters.
4. Review temperature and humidity data for compliance with specified limits.

4.4 Documentation

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

4.5 Review and Approval

1. Submit environmental 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. Environmental Monitoring Plan
2. Environmental Monitoring Logs
3. Environmental Monitoring Reports
4. Temperature and Humidity Records
5. Calibration Records for Monitoring Equipment

7) Reference, if any

Good Manufacturing Practices (GMP) guidelines
ISO 14644-1: Cleanrooms and associated controlled environments
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

8) SOP Version

Version 1.0