Standard Operating Procedure for Environmental Monitoring during Material Dispensing

Department	Creams
SOP No.	SOP/CRM/007/2025
Supersedes	SOP/CRM/007/2022
Page No.	Page 1 of 6
Issue Date	30/03/2025
Effective Date	05/04/2025
Review Date	30/03/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the environmental monitoring requirements during the material dispensing process. This ensures that all dispensing activities occur under controlled environmental conditions, preventing contamination and ensuring the integrity and quality of the materials used in the cream formulations.

2. Scope

This SOP applies to all dispensing operations involving raw materials and excipients within the Creams Department. It covers the environmental conditions required for dispensing, including temperature, humidity, airflow, and cleanliness.

3. Responsibilities

• Production Personnel: Responsible for ensuring that the material dispensing process takes place in an environment that meets the specified environmental conditions, as outlined in this SOP.
• Maintenance Team: Ensures that all HVAC (heating, ventilation, and air conditioning) systems, filters, and other environmental controls are functioning correctly and are regularly maintained.
• Quality Control (QC): Responsible for monitoring environmental conditions during material dispensing, performing regular checks, and ensuring compliance with specified limits.
• Quality Assurance (QA): Ensures that the environmental monitoring process is followed, records are maintained, and deviations are addressed promptly.

4. Accountability

The Head of Creams Manufacturing is accountable for ensuring that the material dispensing process is carried out under appropriate environmental conditions. The QA Manager is ultimately responsible for overseeing the environmental monitoring program and ensuring compliance with this SOP.

5. Procedure

5.1 Environmental Conditions for Dispensing

1. Ensure that the dispensing area is maintained at a controlled temperature (typically between 20°C to 25°C) and relative humidity (typically between 40% and 60%). The area should be free from dust, drafts, and any contamination risks.
2. The area should be equipped with air filtration systems to maintain cleanroom-like conditions during the dispensing process. The air exchange rate should meet the requirements specified for the dispensing area.
3. The dispensing area must be maintained in a manner that prevents the entry of pests and foreign particles that could contaminate the materials.

5.2 Environmental Monitoring

1. Environmental conditions such as temperature, humidity, and airflow should be continuously monitored during material dispensing activities. This can be achieved using automated monitoring systems or manual checks.
2. Temperature and humidity should be recorded at regular intervals (at least every hour) during the dispensing process. If the temperature or humidity falls outside the acceptable limits, the dispensing process must be halted immediately, and the issue should be addressed before proceeding.
3. The cleanliness of the dispensing area should be monitored, with a regular cleaning schedule in place to maintain a contamination-free environment. Any spills or contamination should be immediately cleaned and documented.

5.3 Calibration and Maintenance of Environmental Equipment

1. Ensure that environmental monitoring equipment, such as thermometers, hygrometers, and air quality sensors, are regularly calibrated according to the manufacturer’s specifications. Calibration should be performed at least once a year or as needed.
2. The maintenance team must ensure that HVAC systems, air filters, and other environmental control systems are regularly inspected and maintained to ensure that they function optimally during the dispensing process.

5.4 Documentation of Environmental Monitoring

1. All environmental monitoring activities should be documented in the Environmental Monitoring Log. This log should include the date, time, and the name of the person conducting the monitoring.
2. Any deviations from the required environmental conditions should be immediately reported to the QA team. The deviation should be documented in the Environmental Deviation Report, and corrective actions should be initiated.
3. The Environmental Monitoring Log and any deviation reports should be reviewed by the QA team to ensure that corrective actions are implemented and that the conditions meet GMP standards.

5.5 Corrective Actions for Deviations

1. In case of environmental deviations, such as out-of-range temperature or humidity, immediately suspend the dispensing process and investigate the root cause of the deviation.
2. The QA team should assess the situation and determine if the material dispensing process can be safely resumed. If the deviation affects the quality of the dispensed materials, the batch should be put on hold and further testing may be required.
3. Corrective actions should be documented, and preventive measures should be implemented to avoid future occurrences of similar deviations.

5.6 Final Review and Approval

1. The QA team should conduct regular reviews of environmental monitoring records to ensure that the dispensing environment complies with the required conditions. This review should include checking calibration records, maintenance logs, and the Environmental Monitoring Log.
2. After review, the QA team will approve the environmental conditions for the dispensing process to continue. If any issues are identified during the review, corrective actions should be implemented before approving further dispensing activities.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

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

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Internal SOP for Environmental Control and Monitoring

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

Material Name	Batch Number	Temperature	Humidity	Time/Date	Monitored By
Active Ingredient A	12345	22°C	45%	30/03/2025	John Doe

Annexure-2: Environmental Deviation Report

Deviation Type	Material Name	Batch Number	Time/Date	Corrective Actions Taken	Reported By
Out of Range Temperature	Active Ingredient A	12345	30/03/2025	Adjusted HVAC system	John Doe

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head