Creams: SOP for Environmental Monitoring in Manufacturing Areas – V 2.0

Standard Operating Procedure for Environmental Monitoring in Manufacturing Areas

Department	Creams
SOP No.	SOP/CRM/056/2025
Supersedes	SOP/CRM/056/2022
Page No.	Page 1 of 7
Issue Date	02/12/2025
Effective Date	07/12/2025
Review Date	02/12/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the guidelines for environmental monitoring in manufacturing areas of the Creams Department. This monitoring ensures that the manufacturing environment is maintained within the required standards for cleanliness, temperature, humidity, and air quality, which are crucial to product quality, safety, and compliance with GMP (Good Manufacturing Practices).

2. Scope

This SOP applies to all manufacturing areas involved in the production of creams, including mixing, homogenization, and packaging areas. It includes procedures for monitoring environmental conditions such as air quality, temperature, humidity, and microbial contamination in these areas.

3. Responsibilities

Production Team: Responsible for maintaining a clean and controlled environment during the manufacturing process and ensuring that all environmental monitoring procedures are followed.
Quality Control (QC): Responsible for conducting environmental monitoring and ensuring that all environmental parameters meet the required standards for production. QC is also responsible for reporting any deviations and initiating corrective actions.
Quality Assurance (QA): Ensures that the environmental monitoring system complies with GMP standards and that records are complete, accurate, and readily available for inspection.
Maintenance Team: Responsible for ensuring that HVAC systems, filters, and other environmental control systems are properly maintained and functioning according to specifications.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring the implementation of this SOP in the manufacturing areas. The QA Manager is accountable for ensuring that all environmental monitoring activities are conducted according to this SOP and that any deviations are promptly addressed.

5. Procedure

5.1 Environmental Monitoring Plan

Develop and maintain an environmental monitoring plan that includes the following key parameters:
- Air quality (particulate levels, microbial contamination)
- Temperature
- Humidity
- Surface cleanliness (e.g., microbial testing of surfaces in critical areas)
The monitoring plan should define the frequency of checks, the equipment used, and the areas to be monitored in each manufacturing zone.
The plan should be reviewed annually and updated as needed to ensure compliance with GMP and regulatory requirements.

5.2 Air Quality Monitoring

Conduct air quality monitoring to measure particulate matter and microbial contamination levels in the manufacturing areas.
Air quality testing should be conducted using validated particle counters and microbial air samplers.
Monitoring should be done at regular intervals during production, with more frequent checks in high-risk areas, such as filling and packaging zones.
Ensure that the air quality meets the specified limits for particulate matter (e.g., less than 100 particles per cubic meter) and microbial contamination (e.g., no more than 10 CFUs per cubic meter).
If air quality fails to meet the specifications, identify the source of contamination, address the issue (e.g., HVAC system adjustments), and re-test the air quality.

5.3 Temperature and Humidity Monitoring

Monitor temperature and humidity levels in the manufacturing areas regularly to ensure they remain within the specified range. For most cream manufacturing processes, temperature should be maintained between 20°C and 25°C, and humidity should be kept between 40% and 60%.
Use calibrated temperature and humidity sensors placed in various locations throughout the manufacturing area to continuously record data.
If temperature or humidity levels fall outside the specified range, initiate corrective actions, such as adjusting the HVAC system, and document any deviations in the batch record.

5.4 Surface Cleanliness Monitoring

Conduct surface cleanliness monitoring by sampling critical surfaces (e.g., mixing vessels, counters, equipment) for microbial contamination at specified intervals.
Use contact plates, swabs, or other validated methods to collect samples and send them to the QC lab for microbial testing.
Ensure that all surfaces meet the required standards for microbial contamination (e.g., no more than 1 CFU per 10 cm² in clean areas).
If any surfaces exceed the acceptable microbial limits, take corrective actions such as additional cleaning, sanitization, or equipment replacement.

5.5 Equipment Calibration and Maintenance

Ensure that all environmental monitoring equipment, including particle counters, air samplers, temperature and humidity sensors, are calibrated regularly to maintain accuracy.
The Maintenance Team should conduct routine checks and calibration of environmental control systems (e.g., HVAC, air filtration systems) according to the manufacturer’s specifications and internal standards.
Maintain records of equipment calibration and maintenance, and ensure that any deviations or malfunctions are documented and resolved promptly.

5.6 Documentation and Reporting

Document all environmental monitoring activities in the Environmental Monitoring Log, including test results, corrective actions taken, and any deviations from specified limits.
Ensure that batch records include relevant environmental data (e.g., air quality, temperature, humidity) for traceability and compliance purposes.
QA must review and approve all environmental monitoring records and ensure that they are available for inspection during internal audits or regulatory inspections.

5.7 Corrective and Preventive Actions (CAPA)

If any environmental monitoring results fall outside acceptable limits, initiate a Corrective and Preventive Action (CAPA) process to investigate the root cause of the deviation and implement corrective measures.
Document all CAPA actions, including investigations, root cause analysis, corrective actions, and preventive measures, in the CAPA Log.
Review the effectiveness of corrective actions during subsequent monitoring sessions to ensure the issue has been resolved.

5.8 Final Approval

Once all environmental monitoring parameters are within acceptable limits and corrective actions have been implemented, QA must approve the batch for further processing or packaging.
Ensure that all environmental monitoring records are properly archived and accessible for review during future audits or inspections.

6. Abbreviations

QC: Quality Control
QA: Quality Assurance
GMP: Good Manufacturing Practices
CAPA: Corrective and Preventive Action
HVAC: Heating, Ventilation, and Air Conditioning

7. Documents

Environmental Monitoring Log (Annexure-1)
Calibration and Maintenance Records (Annexure-2)
CAPA Log (Annexure-3)

8. References

Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
FDA Guidelines for Cosmetics Manufacturing

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

Parameter	Location	Time	Result	Action Taken
Air Quality	Mixing Area	08:00 AM	Pass	None

Annexure-2: Calibration and Maintenance Records

Equipment	Calibration Date	Calibration Due Date	Next Calibration
Temperature Sensor	01/11/2025	01/12/2025	01/12/2025

Annexure-3: CAPA Log

Issue	Root Cause	Corrective Action	Preventive Action	Completion Date
High Temperature	HVAC malfunction	Repaired HVAC system	Monthly system checks	03/11/2025

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