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 |