Capsule: SOP for Controlling Temperature and Humidity in Manufacturing Areas – V 2.0

Auditor

2 weeks ago

Standard Operating Procedure for Controlling Temperature and Humidity in Manufacturing Areas

Department	Capsule Manufacturing
SOP No.	SOP/CM/063/2025
Supersedes	SOP/CM/063/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to ensure proper control of temperature and humidity levels in the manufacturing areas to maintain the quality and stability of the capsule formulation. This is essential to meet regulatory standards and ensure the proper functioning of the capsule production process.

2. Scope

This SOP applies to all capsule manufacturing areas, including production rooms, drying areas, and storage areas for raw materials and finished products. It covers the procedures for monitoring, controlling, and documenting temperature and humidity levels during the manufacturing process.

3. Responsibilities

Manufacturing Team: Responsible for maintaining the proper temperature and humidity settings in the production areas, ensuring that equipment is functioning properly, and addressing any deviations promptly.
Quality Control (QC) Team: Responsible for monitoring temperature and humidity levels regularly and conducting audits to ensure compliance with the required specifications.
Quality Assurance (QA) Team: Ensures that temperature and humidity controls are maintained according to GMP guidelines, reviews documentation, and verifies compliance during audits.
Maintenance Team: Responsible for maintaining and calibrating temperature and humidity control systems and ensuring that they are functioning correctly.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that temperature and humidity levels in manufacturing areas are controlled according to this SOP. The QA Manager is responsible for ensuring compliance with this procedure and reviewing records for regulatory compliance.

5. Procedure

5.1 Pre-Production Setup

Before starting production, ensure the following steps are completed to control temperature and humidity:

Temperature and Humidity Settings
1. Set the temperature and humidity levels according to the requirements for the specific manufacturing process. Typical temperature ranges are between 20°C and 25°C, with humidity levels ranging from 30% to 60%, depending on the material and process requirements.
2. Check that the temperature and humidity control equipment is properly calibrated before starting production.
Environmental Equipment Inspection
1. Inspect HVAC (Heating, Ventilation, and Air Conditioning) systems, humidifiers, dehumidifiers, and thermostats to ensure they are in good working condition. Ensure that backup systems are available in case of failure.
Documentation
1. Document the target temperature and humidity settings for each production area, and ensure that all relevant equipment is listed in the batch production records.

5.2 Continuous Monitoring of Temperature and Humidity

During production, continuously monitor the temperature and humidity levels in the manufacturing areas:

Continuous Monitoring
1. Use automated temperature and humidity monitoring systems to continuously track environmental conditions in real time. Ensure that all monitoring devices are regularly calibrated.
Manual Inspections
1. In addition to automated systems, conduct manual temperature and humidity checks at least once every 4 hours to verify the automated system readings. Record the results in the appropriate log.
Alarm Systems
1. Ensure that alarm systems are in place to notify operators if temperature or humidity levels fall outside the acceptable range. The system should trigger an immediate investigation and corrective action.

5.3 Corrective Actions for Deviations

If temperature or humidity deviations occur, follow these steps:

Investigate the Cause
1. Identify the cause of the deviation. Common causes may include HVAC system malfunction, material handling issues, or operator error.
2. Check for any environmental disturbances, such as external weather conditions, which may be influencing the internal temperature or humidity.
Implement Corrective Action
1. If the HVAC system is malfunctioning, immediately repair or adjust the system. If the deviation is due to other causes, address the issue accordingly (e.g., adjust the material handling process or relocate products to a more controlled area).
Verify Corrective Actions
1. Once corrective actions are implemented, verify that temperature and humidity levels have returned to the acceptable range. Continue monitoring closely for several hours to ensure stability.
Documentation of Deviations
1. Document any deviations, including the cause, corrective actions taken, and verification results. Include any impact on production and whether any product quality was affected.

5.4 Post-Production Review

After production, ensure the following checks are completed:

Environmental Records Review
1. Review the environmental monitoring records to verify that temperature and humidity levels were maintained within the acceptable ranges during production. Ensure that all deviations have been properly documented and investigated.
Compliance Check
1. Verify that all temperature and humidity records are in compliance with GMP standards and any relevant regulatory requirements (e.g., FDA, EMA, or ICH guidelines).

5.5 Equipment Maintenance and Calibration

Ensure that all environmental control equipment is properly maintained and calibrated:

Routine Maintenance
1. Perform routine maintenance on temperature and humidity control equipment, including air conditioning, humidity controllers, and automated monitoring systems.
2. Check all systems for proper functioning and replace any components that show signs of wear or malfunction.
Calibration
1. Ensure that temperature and humidity sensors are calibrated at regular intervals, based on the manufacturer’s recommendations, or at least once every six months.

5.6 Documentation and Record-Keeping

Proper documentation of environmental controls is critical for regulatory compliance:

Environmental Monitoring Records
1. Document all temperature and humidity readings, including any deviations and the corresponding corrective actions taken. Maintain these records in batch production files for traceability.
Calibration and Maintenance Records
1. Maintain records of calibration and maintenance activities for temperature and humidity control equipment, including calibration certificates and maintenance logs.
Deviation Reports
1. Document any deviations from the required environmental conditions, including the cause of the deviation, corrective actions, and verification results.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance

7. Documents

Temperature and Humidity Monitoring Record (Annexure-1)
Calibration and Maintenance Record (Annexure-2)
Deviation Report (Annexure-3)

8. References

USP <1163> – Pharmaceutical Dosage Forms: Capsules
FDA Guidelines for Capsule Manufacturing
International Conference on Harmonization (ICH) Guidelines for Pharmaceutical 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: Temperature and Humidity Monitoring Record

Batch ID	Temperature	Humidity	Time	Deviation	Operator Name
Batch 001	22°C	40%	10:00 AM	No Deviation	John Doe

Annexure-2: Calibration and Maintenance Record

Equipment ID	Calibration Date	Technician	Calibration Results
Thermostat 15	01/02/2025	John Smith	Within Tolerance

Annexure-3: Deviation Report

Deviation ID	Description	Corrective Action	Action Taken By
DR-001	Humidity above 60%	Adjusted dehumidifier settings	Manufacturing Supervisor

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated temperature and humidity parameters	Standardization	QA Head