SOP for Recording Environmental Monitoring Data – V 2.0

Procedure for Recording Environmental Monitoring Data

Department	Quality Assurance (QA)/Quality Control (QC)/Microbiology
SOP No.	SOP/Ointment/169
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for recording and maintaining environmental monitoring data in pharmaceutical manufacturing. Proper documentation ensures compliance with Good Manufacturing Practices (GMP) and regulatory guidelines, ensuring a controlled manufacturing environment.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Microbiology departments involved in monitoring, recording, and analyzing environmental parameters in manufacturing and storage areas.

3. Responsibilities

Environmental Monitoring Technician: Conducts environmental sampling and records data.
Microbiologist: Analyzes microbiological samples and trends.
QA Officer: Reviews environmental data for compliance.
QA Manager: Approves monitoring reports and ensures regulatory adherence.

4. Accountability

The QA and Microbiology Managers are accountable for ensuring that all environmental monitoring data is properly recorded, reviewed, and maintained in compliance with GMP, FDA, ICH, and WHO regulations.

5. Procedure

5.1 Environmental Monitoring Parameters

The following environmental parameters must be monitored:

Temperature: Recorded in controlled storage and manufacturing areas.
Humidity: Monitored in areas sensitive to moisture.
Microbial Contamination: Assessed using settle plates, air sampling, and surface swabbing.
Particulate Count: Evaluated in classified cleanrooms.
Air Pressure

Differential: Checked between classified areas.

Water and Compressed Air Quality: Monitored for microbial and chemical contamination.

5.2 Frequency of Environmental Monitoring

Daily: Temperature, humidity, and differential pressure readings.
Weekly: Surface and air microbial sampling.
Monthly: Particle count assessment.
Quarterly: Water and compressed air quality testing.
Annual: Comprehensive environmental validation.

5.3 Recording Environmental Monitoring Data

All data must be recorded in the **Environmental Monitoring Log (Annexure-1).**
Entries must be made in **indelible ink** for paper records or in a **validated electronic system.**
Data must include:
- Monitoring date and time.
- Parameter measured.
- Observed value.
- Acceptance criteria.
- Technician’s signature.

5.4 Handling Out-of-Specification (OOS) Environmental Data

If an environmental parameter exceeds its acceptance limit:
- A **Deviation Report (DR)** must be initiated.
- Immediate corrective actions must be taken.
- Repeat testing must be conducted to confirm findings.
The deviation report must be reviewed and approved by QA.

5.5 Data Review and Trend Analysis

QA must conduct **monthly reviews** of environmental monitoring records.
Statistical trend analysis must be performed to identify:
- Increasing microbial contamination levels.
- Fluctuations in temperature and humidity.
- Changes in particulate counts.
Any trends indicating deterioration in environmental control must be investigated.

5.6 Retention of Environmental Monitoring Records

All environmental monitoring records must be retained for **a minimum of 5 years.**
Electronic backups must be performed **weekly.**
Records must be accessible for **regulatory audits and inspections.**

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
QC – Quality Control
OOS – Out of Specification
FDA – Food and Drug Administration
ICH – International Council for Harmonisation

7. Documents

Environmental Monitoring Log (Annexure-1)
Deviation Report Form (Annexure-2)

8. References

ICH Q7 – GMP for Active Pharmaceutical Ingredients
WHO Guidelines on Environmental Monitoring
US FDA Guidance on Cleanroom and Environmental Control

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Environmental Monitoring Log

Date	Parameter	Observed Value	Acceptance Limit	Technician	QA Review
02/02/2025	Temperature	22°C	15-25°C	John Doe	Approved

Annexure-2: Deviation Report Form

Date	Parameter	Observed Value	Root Cause	Corrective Action	QA Approval
02/02/2025	Humidity	80%	HVAC Malfunction	HVAC System Serviced	Approved

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Environmental Monitoring Procedures	Improved Compliance	QA Head