Standard Operating Procedure for Monitoring Cleaning Cycles in Capsule Manufacturing

Department	Capsule Manufacturing
SOP No.	SOP/CM/131/2025
Supersedes	SOP/CM/131/2022
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 establish standardized procedures for monitoring cleaning cycles in capsule manufacturing areas. This process ensures that all equipment, tools, and production areas are cleaned properly and meet regulatory cleanliness standards. It helps verify that no residues or contaminants are left behind, thereby preventing cross-contamination and maintaining product quality.

2. Scope

This SOP applies to all cleaning cycles conducted in the capsule manufacturing department, including the cleaning of equipment, tools, and production areas such as granulation machines, filling equipment, packaging stations, and environmental surfaces. It includes monitoring the efficiency and compliance of cleaning processes after each batch.

3. Responsibilities

• Production Operators: Responsible for performing cleaning as per the schedule and ensuring the equipment is properly cleaned before starting the next batch. Operators must also report any cleaning deficiencies.
• Cleaning Staff: Responsible for cleaning the manufacturing areas, tools, and equipment as per the defined cleaning cycles and ensuring that all cleaning steps are properly executed.
• Quality Control (QC) Team: Responsible for verifying that the cleaning cycles meet the required cleanliness standards and conducting visual and sample-based inspections as necessary.
• Quality Assurance (QA) Team: Ensures that all cleaning processes are documented, reviewed, and compliant with GMP standards. They are also responsible for reviewing and approving cleaning logs.
• Maintenance Team: Responsible for maintaining the equipment, including ensuring it is in good working condition and free from any issues that may affect the cleaning process.
• Production Supervisor: Oversees the monitoring of cleaning cycles and ensures compliance with the SOP. They also address any issues related to cleaning deficiencies or failures in the cleaning process.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that cleaning cycles are monitored according to this SOP. The QA Manager is responsible for ensuring that the monitoring process complies with GMP and that the cleaning logs are complete and accurate.

5. Procedure

5.1 Preparation for Monitoring Cleaning Cycles

Before monitoring cleaning cycles, the following steps must be completed:

1. Check Cleaning Schedule
   1. Review the cleaning schedule to ensure that all required cleaning cycles are documented and that the necessary equipment and staff are available for cleaning.
   2. Confirm that the cleaning process has been completed before the monitoring procedure begins.
2. Gather Monitoring Tools
   1. Ensure that all necessary monitoring tools are available, including inspection checklists, sampling tools, testing kits, and cleaning logs.
   2. Ensure that the tools are calibrated and ready to use for the monitoring process.
3. Prepare Monitoring Log
   1. Prepare the Cleaning Cycle Monitoring Log (Annexure-1) to document all monitoring actions, including inspection results, discrepancies, and actions taken.

5.2 Monitoring Cleaning Cycles

Follow these steps to monitor the cleaning cycles:

1. Visual Inspection
   1. Inspect the cleaned equipment, tools, and production areas for visible contamination or residue. Ensure that all surfaces are free from dust, powder, and product remnants.
   2. Check the cleanliness of equipment parts that are difficult to clean or prone to material buildup.
2. Sampling for Residues
   1. If visual inspection does not provide sufficient assurance of cleanliness, take surface swabs or sample materials from the cleaned areas for analysis.
   2. Send the samples to the QC team for testing to ensure that no residues are left behind.
3. Verify Cleaning Agent Use
   1. Ensure that the correct cleaning agents have been used during the cleaning cycle, in the proper amounts and concentrations as per the approved cleaning procedure.
   2. Verify that the cleaning agents have been thoroughly rinsed from the equipment to avoid contamination.
4. Check Drying of Equipment
   1. Verify that all equipment, including high-humidity areas, has been properly dried after cleaning to prevent microbial growth or material buildup.
   2. Ensure that drying procedures, such as air drying or using fans, are carried out effectively.

5.3 Post-Monitoring Actions

After completing the monitoring steps, take the following actions:

1. Documentation
   1. Record all findings in the Cleaning Cycle Monitoring Log (Annexure-1), including inspection results, any issues or discrepancies, and corrective actions taken.
   2. Ensure that all monitoring actions are signed off by the responsible personnel to confirm the completion of the cleaning verification process.
2. Corrective Actions
   1. If discrepancies or issues are found during the monitoring process, initiate corrective actions according to the Corrective and Preventive Action (CAPA) procedure.
   2. Ensure that the cleaning process is repeated or adjusted as necessary to address the issues identified.
3. Approval
   1. Once the cleaning and monitoring process is complete, ensure that the equipment is approved for use by the QA team.
   2. Document the approval in the Cleaning Cycle Monitoring Log (Annexure-1) before allowing the next production run to commence.

5.4 Documentation

Ensure that all actions are properly documented for traceability and compliance:

1. Complete Monitoring Log
   1. Ensure that all monitoring activities, including operator details, monitoring times, results, and corrective actions, are recorded in the Cleaning Cycle Monitoring Log (Annexure-1).
2. Post-Monitoring Inspection
   1. Document the results of the post-monitoring inspection in the Equipment Inspection Log (Annexure-2), including any issues discovered during the inspection.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• CAPA: Corrective and Preventive Action

7. Documents

1. Cleaning Cycle Monitoring Log (Annexure-1)
2. Equipment Inspection Log (Annexure-2)
3. Corrective and Preventive Action Log (CAPA) (Annexure-3)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Cycle Monitoring Log

Batch ID	Monitoring Date	Operator	Inspection Action	Discrepancies	Corrective Actions
Batch 001	02/02/2025	John Doe	Visual inspection, residue check	No discrepancies	None

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
Granulation Equipment 001	02/02/2025	Clean and ready for use	Jane Smith	02/02/2026

Annexure-3: Corrective and Preventive Action Log (CAPA)

Action ID	Action Date	Action Description	Responsible Person	Status
CAPA-001	02/02/2025	Addressed contamination in batch 001	QA Manager	Closed

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 monitoring actions and added corrective action procedures	Improved process accuracy	QA Head