Standard Operating Procedure for Environmental Monitoring

1) Purpose

The purpose of this SOP is to establish procedures for environmental monitoring within the manufacturing facility to ensure cleanliness, control of contaminants, and compliance with regulatory requirements.

2) Scope

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

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Environmental Monitoring Team:

Responsible for conducting environmental monitoring activities as per the established procedures.

3.2 Quality Control (QC) Personnel:

Responsible for analyzing environmental monitoring samples and reporting results.

3.3 Facility Manager:

Responsible for ensuring environmental monitoring equipment is maintained and calibrated.

4) Procedure

4.1 Environmental Monitoring Plan:

4.1.1 Develop an environmental monitoring plan based on facility design, operational activities, and regulatory requirements.
4.1.2 Obtain approval for the environmental monitoring plan from Quality Assurance (QA).

4.2 Sampling Locations and Frequency:

4.2.1 Identify critical sampling locations within the facility.
4.2.2 Determine the frequency of environmental monitoring based on risk assessment and regulatory guidelines.
4.2.3 Document sampling locations and monitoring frequency in the Environmental Monitoring Schedule.

4.3 Sample Collection:

4.3.1 Collect environmental monitoring samples using aseptic techniques and appropriate sampling methods.
4.3.2 Record sample collection details, including location, date, time, and personnel involved.
4.3.3 Transport samples to the laboratory for analysis promptly.

4.4 Laboratory Analysis:

4.4.1 Analyze environmental monitoring samples for microbial and non-microbial contaminants.
4.4.2 Record and report analysis results in the Environmental Monitoring Report.
4.4.3 Investigate and document any excursions or deviations from established limits.

4.5 Corrective Actions and Follow-Up:

4.5.1 Initiate corrective actions for any identified excursions or deviations.
4.5.2 Implement preventive actions to mitigate the risk of recurrence.
4.5.3 Document all actions taken and review effectiveness of corrective actions.

5) Abbreviations, if any

QA – Quality Assurance
QC – Quality Control

6) Documents, if any

1. Environmental Monitoring Plan
2. Environmental Monitoring Schedule
3. Environmental Monitoring Report
4. Corrective and Preventive Action (CAPA) Records

7) Reference, if any

1. FDA Guidance on Training of Personnel
2. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0