equipment is maintained and calibrated regularly, as per the SOP.

4. Accountability

The Production Manager is accountable for ensuring that this SOP is followed during the dispensing process and that any deviations are addressed. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Environmental Monitoring Setup

1. Ensure that the dispensing area is equipped with the appropriate environmental monitoring equipment, such as temperature and humidity sensors, particle counters, and air quality monitors.
2. Verify that the equipment is calibrated and functioning correctly before beginning any dispensing activities. Record calibration data in the Equipment Calibration Log (Annexure-1).
3. Set environmental monitoring parameters according to the specifications, which include:
   • Temperature: [Insert Range, e.g., 20-25°C]
   • Humidity: [Insert Range, e.g., 40-60% RH]
   • Particulate Matter: [Insert Standard, e.g., 100 particles per cubic meter]

5.2. Monitoring During Dispensing

1. Environmental conditions must be monitored continuously throughout the material dispensing process to ensure compliance with the set parameters.
2. Record the environmental data in the Environmental Monitoring Log (Annexure-2), noting the date, time, and any deviations from the set conditions.
3. If any deviations are observed (e.g., temperature or humidity out of range, excessive particulate matter), immediately inform the Warehouse Supervisor and stop the dispensing process until the issue is resolved.
4. In case of temperature or humidity deviations, take corrective actions such as adjusting the air conditioning or relocating the materials to another suitable area.

5.3. Corrective Actions for Deviations

1. If environmental parameters are found to be out of specification, suspend material dispensing until the area is restored to acceptable conditions.
2. Investigate the root cause of the deviation, which may include equipment malfunction, air conditioning failure, or human error.
3. Record the corrective actions taken in the Corrective Action Log (Annexure-3), including any repairs or adjustments made, and verify that the environmental conditions are now within specification before resuming dispensing.

5.4. Documentation and Reporting

1. All environmental monitoring data and any deviations should be documented in the Environmental Monitoring Log (Annexure-2) and reviewed by the QC team.
2. Any deviations or corrective actions should be reported to the QA Manager, and an investigation should be conducted to prevent future occurrences.
3. Maintain records of environmental monitoring activities for at least [Insert Time Period, e.g., 3 years] for regulatory review.

5.5. Environmental Monitoring Review

1. The QC team should periodically review environmental monitoring logs to ensure that dispensing areas continue to meet environmental requirements.
2. If trends of non-compliance are identified, a more in-depth investigation should be conducted, and additional corrective actions should be implemented.

5.6. Corrective and Preventive Actions (CAPA)

1. In case of recurring environmental issues, conduct a root cause analysis to identify the underlying cause of the problem.
2. Implement preventive measures to minimize the likelihood of future environmental deviations, such as upgrading equipment, enhancing monitoring practices, or revising operational procedures.
3. Record corrective and preventive actions in the CAPA Log (Annexure-4) and track the effectiveness of the implemented measures.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions

7. Documents

1. Environmental Monitoring Log (Annexure-2)
2. Equipment Calibration Log (Annexure-1)
3. Corrective Action Log (Annexure-3)
4. CAPA Log (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Result	Next Calibration Due
Temperature Sensor 1	01/01/2025	Pass	01/07/2025

Annexure-2: Environmental Monitoring Log

Monitoring Date	Temperature	Humidity	Particulate Matter	Recorded By
06/02/2025	22°C	50%	80 particles/m³	Rajesh Patel

Annexure-3: Corrective Action Log

Deviation	Action Taken	Responsible Party	Resolution Date
Temperature deviation	Adjusted AC, re-monitored	Ravi Kumar	06/02/2025

Annexure-4: CAPA Log

Issue	Root Cause Analysis	Preventive Action	Implemented By	Follow-up Date
Humidity deviation	AC malfunction	Regular AC maintenance	Rajesh Patel	06/03/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated monitoring parameters and corrective actions	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures