designated EM team in controlled API manufacturing environments. It includes monitoring of viable and non-viable particulates, surface swabs, settle plates, air samples, and personnel monitoring.

3. Responsibilities

• EM Team (QC): Performs environmental monitoring, compiles data, and submits reports to QA.
• QA Officer/Executive: Reviews EM results for trends, deviations, and potential contamination events.
• QA Manager: Approves final review reports, recommends CAPA (if required), and ensures compliance.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that environmental monitoring data are reviewed periodically and that appropriate action is taken when out-of-limit conditions are observed.

5. Procedure

5.1 Receipt of EM Data

1. The EM Team shall submit compiled data sheets and summary reports to QA on a weekly/monthly basis depending on the monitoring schedule.
2. Data must include:
   • Date and time of monitoring
   • Sampling locations
   • Method (settle plate, air sampler, swab)
   • CFU counts or particle count readings
   • Acceptance limits

5.2 Review Criteria by QA

1. QA shall review for:
   • Completeness of records
   • Correct entry of data and units
   • Adherence to predefined frequency and locations
   • Results within alert and action limits
   • Consistency with historical trends
2. QA shall use the EM Review Checklist (Annexure-1) to document the review process.

5.3 Trend Analysis

1. QA shall perform periodic (monthly/quarterly) trend analysis:
   • Prepare trend charts or graphs (Annexure-2)
   • Identify gradual increases or recurring high readings
   • Evaluate seasonality or specific shifts/locations with elevated counts
2. Any upward trend beyond alert limit shall trigger investigation.

5.4 Out-of-Limit Results

1. For any EM result exceeding action limits:
   • QA shall initiate a deviation/investigation report
   • Assess cleaning records, maintenance logs, and personnel hygiene data
   • Request resampling (if justified)
   • Raise CAPA as required and document corrective steps

5.5 Reporting and Communication

1. QA shall prepare a QA Review Summary Report for EM data (Annexure-3) including:
   • Total samples reviewed
   • Number of samples within limit, alert, action
   • Deviations reported
   • Corrective actions suggested
2. QA Manager shall sign and distribute the summary to relevant departments (Production, Engineering, QC).

5.6 Annual Review of EM Program

1. QA shall support or lead the annual review of the environmental monitoring program to assess:
   • Effectiveness of monitoring plan
   • Changes in classification or operations
   • Need for revision in sampling locations or frequencies

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• CFU: Colony Forming Units
• EM: Environmental Monitoring
• CAPA: Corrective and Preventive Action

7. Documents

1. EM Review Checklist (Annexure-1)
2. Trend Chart Template (Annexure-2)
3. QA Review Summary Report (Annexure-3)
4. EM Deviation Investigation Form (Annexure-4)

8. References

• WHO TRS 961 Annex 6 – GMP for API
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• 21 CFR Part 211.42 – Design and construction features
• ISO 14644-1 – Classification of Air Cleanliness

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: EM Review Checklist

Parameter	Status	Remarks
Data Complete	Yes	All sample locations included
Result Within Limits	Yes	No OOS
Reviewed By	QA Executive	13/04/2025

Annexure-2: Trend Chart Template

Month	Area	Sample Type	Max CFU	Action Limit
March 2025	API Blending Room	Settle Plate	3	5

Annexure-3: QA Review Summary Report

Reporting Period	Total Samples	Out of Limit	Deviations	Action Taken
March 2025	112	2	1	Resampling & CAPA initiated

Annexure-4: EM Deviation Investigation Form

Date	Area	Sample Type	Observed Result	Action Taken
10/03/2025	Drying Room	Air Sample	15 CFU	Cleaning repeated, retesting OK

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
14/04/2025	2.0	Trend analysis and CAPA requirements added	Compliance with updated EM guidelines	QA Head