Standard Operating Procedure for Controlling Environmental Conditions During Dispensing

Department	Capsule Manufacturing
SOP No.	SOP/CM/012/2025
Supersedes	SOP/CM/012/2022
Page No.	Page 1 of 7
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

To define the procedures for controlling environmental conditions during the dispensing process in capsule manufacturing to ensure product quality and compliance with GMP standards.

2. Scope

This SOP applies to all dispensing operations in capsule manufacturing where environmental conditions, such as temperature, humidity, and airflow, can impact the quality of materials being dispensed.

3. Responsibilities

• Manufacturing Personnel: Responsible for ensuring that the environmental conditions are maintained as per the specified requirements during dispensing activities.
• Quality Control (QC) Team: Ensures that environmental conditions are monitored and verified during dispensing to meet required standards.
• Facilities Personnel: Responsible for maintaining and calibrating the environmental control systems, including HVAC and dehumidifiers, to meet the specified conditions.
• Quality Assurance (QA) Team: Ensures compliance with the environmental conditions and validates the effectiveness of the control systems during dispensing operations.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring environmental conditions are maintained during dispensing. The QA Manager is responsible for ensuring compliance and monitoring the effectiveness of environmental controls.

5. Procedure

5.1 Environmental Control Requirements

Ensure the following environmental conditions are met before commencing the dispensing process:

1. Temperature Control
   1. Ensure that the temperature in the dispensing area is maintained within the specified range (e.g., 20°C – 25°C) to prevent degradation of materials or compromise the dispensing process.
   2. Verify that temperature control systems, such as air conditioning or heating units, are calibrated and functioning properly.
2. Humidity Control
   1. Ensure that the relative humidity in the dispensing area is within the specified range (e.g., 40% – 60%) to avoid clumping, moisture absorption, or material instability.
   2. Use dehumidifiers or humidifiers as necessary to maintain the proper level of humidity in the dispensing environment.
3. Airflow and Ventilation
   1. Ensure that the dispensing area is adequately ventilated to maintain air quality and prevent the buildup of airborne particles that could contaminate materials.
   2. Check that ventilation systems, such as fume hoods or local exhaust systems, are operational and provide sufficient airflow to maintain a safe working environment.

5.2 Monitoring of Environmental Conditions

Implement procedures for continuous monitoring of environmental conditions during dispensing activities:

1. Temperature and Humidity Monitoring
   1. Install temperature and humidity sensors in the dispensing area to continuously monitor environmental conditions.
   2. Record the temperature and humidity levels at regular intervals (e.g., every hour) to ensure compliance with specified ranges.
   3. Any deviation from the specified ranges should be immediately reported to the QA and Facilities teams for corrective action.
2. Air Quality Monitoring
   1. Use air quality monitors to measure particulate matter and airborne contaminants in the dispensing area.
   2. Ensure that the air quality meets acceptable standards and that any contamination is addressed promptly.

5.3 Corrective Actions for Out-of-Specification Environmental Conditions

If environmental conditions fall outside of the specified ranges during dispensing, take the following corrective actions:

1. Stop Dispensing Activities
   1. If temperature, humidity, or air quality falls outside the specified range, halt dispensing activities to prevent any potential impact on material quality.
2. Investigate the Cause
   1. Investigate the root cause of the deviation (e.g., malfunctioning HVAC system, equipment failure, door left open).
   2. Ensure that corrective actions are taken to restore the environmental conditions to the required specifications.
3. Resume Dispensing
   1. Once the environmental conditions are restored to the acceptable range, resume dispensing activities.
   2. Document the deviation and corrective actions taken in the Incident Report (Annexure-1) and Discrepancy Report (Annexure-2).

5.4 Documentation and Record-Keeping

Ensure that environmental conditions are properly documented for regulatory compliance and traceability:

1. Environmental Monitoring Log
   1. Maintain a log of temperature, humidity, and air quality readings taken throughout the dispensing process in the Environmental Monitoring Log (Annexure-3).
   2. Ensure that the log is signed by the personnel who performed the monitoring and includes the time and date of each reading.
2. Incident Report
   1. Document any deviations in environmental conditions and the corrective actions taken in the Incident Report (Annexure-1).
   2. Ensure that the report includes the impact of the deviation, the cause, and any measures taken to prevent recurrence.
3. Discrepancy Report
   1. Record any discrepancies between actual and specified environmental conditions in the Discrepancy Report (Annexure-2), along with corrective actions and approval from the QA team.

5.5 Training and Awareness

Ensure that all personnel involved in dispensing are properly trained on environmental control procedures:

1. Training Program
   1. Develop and implement a training program to educate dispensing personnel on the importance of controlling environmental conditions and the procedures to follow.
   2. Provide refresher training at regular intervals to ensure ongoing awareness and compliance with SOPs.
2. Monitoring Compliance
   1. Monitor personnel compliance with environmental control procedures and provide corrective actions if necessary.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• HVAC: Heating, Ventilation, and Air Conditioning
• API: Active Pharmaceutical Ingredient

7. Documents

1. Environmental Monitoring Log (Annexure-3)
2. Incident Report (Annexure-1)
3. Discrepancy Report (Annexure-2)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ISO 14644 – Cleanrooms and associated controlled environments

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Incident Report

Date	Material Involved	Issue Description	Corrective Action
04/02/2025	API-123 td>	Temperature deviation in dispensing area	Restored proper temperature and recalibrated HVAC system

Annexure-2: Discrepancy Report

Date	Environmental Condition	Deviation	Corrective Action
05/02/2025	Humidity	Humidity exceeded 60%	Adjusted dehumidifiers to bring levels back to range

Annexure-3: Environmental Monitoring Log

Date	Time	Temperature (°C)	Humidity (%)	Personnel
03/02/2025	10:00 AM	22°C	45%	Jane Smith

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 environmental control procedures	Standardization and clarity	QA Head