1) SOP for Environmental Monitoring

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for monitoring and recording environmental conditions in the manufacturing area to ensure compliance with regulatory requirements and maintain product quality.

3) Scope

This SOP applies to all areas within the manufacturing facility where pharmaceutical products are processed, stored, or packaged.

4) Responsibilities

• Quality Assurance (QA) Department: Responsible for implementing and overseeing environmental monitoring activities.
• Production Department: Responsible for providing access to production areas and supporting environmental monitoring.
• Facilities Management: Responsible for maintaining monitoring equipment and calibration.
• Regulatory Affairs: Responsible for ensuring compliance with regulatory guidelines related to environmental monitoring.

5) Procedure

1. Monitoring Parameters
   1. Identify critical monitoring points based on risk assessment (e.g., cleanrooms, critical production areas).
   2. Determine parameters to monitor (e.g., temperature, humidity, airborne particles).
2. Monitoring Schedule
   1. Establish a monitoring schedule based on regulatory requirements and internal policies.
   2. Define frequency of monitoring (e.g., continuous, daily, weekly).
3. Monitoring Procedures
   1. Use calibrated monitoring equipment to measure environmental parameters accurately.
   2. Follow documented procedures for taking samples or measurements.
   3. Record monitoring data promptly and accurately.
4. Data Analysis and Reporting
   1. Analyze monitoring data to identify trends or deviations from established limits.
   2. Investigate any out-of-specification results and document investigations.
   3. Report findings to relevant departments and management as required.
5. Documentation and Records
   1. Maintain records of environmental monitoring activities, including raw data, summaries, and reports.
   2. Archive records according to company procedures and regulatory requirements.
   3. Review and approve environmental monitoring records periodically.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Environmental Monitoring Plan
• Monitoring Equipment Calibration Records
• Environmental Monitoring Reports

8) Reference, if any

• Good Manufacturing Practice (GMP) Guidelines
• ISO standards for environmental monitoring
• Company-specific environmental monitoring procedures

9) SOP Version

Version 1.0