Environmental Monitoring Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for monitoring and controlling the manufacturing environment to ensure it meets specified quality standards.

2) Scope

This SOP applies to all areas within the pharmaceutical manufacturing facility where environmental monitoring is required.

3) Responsibilities

– QC personnel are responsible for conducting environmental monitoring.
– Maintenance personnel are responsible for ensuring that environmental control systems are functioning properly.
– QA personnel are responsible for reviewing and approving monitoring results and ensuring compliance with regulatory standards.

4) Procedure

1. Monitoring Plan
1.1. Develop an environmental monitoring plan that includes the frequency and locations of sampling.
1.2. Define the parameters to be monitored, such as temperature, humidity, airborne particulates, and microbial contamination.
2. Sampling Methods
2.1. Use appropriate sampling methods for each parameter:
2.1.1. Temperature and humidity: Use calibrated thermohygrometers.
2.1.2. Airborne particulates: Use particle counters.
2.1.3. Microbial contamination: Use settle plates, contact plates, and air samplers.
3. Sample Collection
3.1. Collect samples according to the defined monitoring plan.
3.2. Ensure that sampling equipment is properly calibrated and maintained.
3.3. Label each sample with the date, time, location, and parameter being monitored.
4. Sample Analysis
4.1. Analyze samples in the QC laboratory using validated methods.
4.2. Record the results of the analysis, including any deviations from acceptable limits.
5. Data Recording and Trending
5.1. Record all monitoring results in the environmental monitoring log.
5.2. Perform trend analysis to identify patterns or recurring issues.
6. Deviations and Out-of-Specification Results
6.1. Investigate any deviations or out-of-specification (OOS) results immediately.
6.2. Identify the root cause of the deviation or OOS result.
6.3. Implement corrective and preventive actions (CAPA) to address the issue.
7. Review and Approval
7.1. Submit the environmental monitoring log and any deviation reports to the QA department for review.
7.2. QA will review and approve the results, ensuring that all necessary actions have been taken and that the environment meets specified quality standards.
8. Reporting
8.1. Prepare periodic reports summarizing the environmental monitoring data and trends.
8.2. Share reports with relevant departments and regulatory authorities as required.
9. Maintenance of Control Systems
9.1. Ensure that HVAC systems, HEPA filters, and other environmental control systems are regularly maintained and calibrated.
9.2. Document all maintenance activities and repairs.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– OOS: Out-of-Specification
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Environmental Monitoring Plan
– Environmental Monitoring Log
– Deviation Report Form
– CAPA Report Form

7) Reference, if any

– FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing
– ISO 14644-1:2015 – Cleanrooms and Associated Controlled Environments

8) SOP Version

Version 1.0