Standard Operating Procedure for Ensuring Compliance with GMP in Capsule Production

Department	Capsule Manufacturing
SOP No.	SOP/CM/105/2025
Supersedes	SOP/CM/105/2022
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 the procedure for ensuring compliance with Good Manufacturing Practices (GMP) during capsule production. This procedure is designed to maintain the highest quality standards and ensure that all aspects of capsule manufacturing meet regulatory requirements.

2. Scope

This SOP applies to all aspects of capsule production, including raw material handling, formulation, encapsulation, drying, quality control testing, and packaging. It outlines the responsibilities and procedures to ensure that capsule production processes comply with GMP guidelines at all stages.

3. Responsibilities

• Production Operators: Responsible for following the procedures outlined in this SOP, ensuring that capsule production processes are in compliance with GMP standards.
• Quality Control (QC) Team: Responsible for overseeing the testing and monitoring of production processes to ensure compliance with GMP. QC will also document and report any deviations from GMP.
• Quality Assurance (QA) Team: Ensures that the entire production process adheres to GMP standards and reviews all documentation to confirm compliance with regulatory requirements.
• Production Supervisor: Responsible for supervising the production process and ensuring that all operators follow GMP guidelines. The supervisor must also manage corrective actions in case of deviations from GMP.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring compliance with GMP during the production process. The QA Manager is responsible for reviewing and approving all GMP compliance-related documentation and actions.

5. Procedure

5.1 GMP Training and Education

Ensure that all personnel involved in capsule production are properly trained and educated on GMP guidelines:

1. Provide Initial GMP Training
   1. All new employees involved in capsule production must undergo an initial GMP training session before beginning work.
   2. The training should cover GMP regulations, quality control procedures, and the importance of maintaining compliance in capsule production.
2. Conduct Regular Refresher Training
   1. Conduct periodic refresher training for all production staff to ensure that they stay updated with any changes in GMP regulations or internal processes.
   2. Keep records of all training sessions, including the names of attendees, training dates, and topics covered, in the Training Log (Annexure-1).

5.2 Document Control and Record Keeping

Ensure that all manufacturing records are accurate, complete, and maintained according to GMP guidelines:

1. Maintain Accurate Batch Records
   1. Ensure that all batch records are completed accurately, including the recording of raw material batches, production processes, equipment used, and test results.
   2. Batch records should be signed off by authorized personnel and reviewed by QA for completeness and accuracy.
2. Document Handling
   1. Ensure that all GMP-related documents (e.g., batch records, SOPs, test results) are properly stored and controlled to prevent unauthorized access or changes.
   2. Use a document control system to track the revision history and approval of all GMP-related documents.

5.3 Equipment Calibration and Maintenance

Ensure that all equipment used in capsule production is properly calibrated, maintained, and functioning:

1. Regular Calibration of Equipment
   1. All equipment used in capsule manufacturing, such as filling machines, drying ovens, and QC testing equipment, must be calibrated according to the manufacturer’s specifications.
   2. Calibration records should be maintained in the Equipment Calibration Log (Annexure-2), including calibration dates, results, and any corrective actions taken.
2. Preventive Maintenance
   1. Establish a preventive maintenance schedule for all equipment used in capsule production. This schedule should include routine inspections, cleaning, and part replacements to ensure optimal performance.
   2. Record all maintenance activities in the Maintenance Log (Annexure-3) to ensure traceability and compliance with GMP guidelines.

5.4 Production and Process Controls

Ensure that all production processes are controlled and monitored to maintain compliance with GMP:

1. Monitor Critical Process Parameters
   1. Monitor critical parameters during capsule manufacturing, such as temperature, humidity, capsule weight, and fill volume, to ensure that they remain within acceptable limits.
   2. Use automated systems to continuously monitor these parameters, and record the data in the Production Monitoring Log (Annexure-4).
2. Investigate Deviations
   1. If any process deviation is detected, immediately investigate the cause of the deviation, and implement corrective actions to return the process to compliance.
   2. Document all deviations and corrective actions in the Deviation Log (Annexure-5), and review them to prevent recurrence.

5.5 Compliance Audits and Inspections

Regularly conduct audits and inspections to verify compliance with GMP and regulatory requirements:

1. Conduct Internal Audits
   1. Conduct regular internal GMP audits to assess compliance with SOPs, equipment calibration, documentation, and overall manufacturing processes.
   2. Audit findings should be documented, and corrective actions should be implemented as necessary.
2. Prepare for External Audits
   1. Prepare for external GMP inspections by regulatory bodies (e.g., FDA, EMA) by ensuring that all documents, records, and procedures are up-to-date and in compliance with regulatory requirements.
   2. Address any observations made during external audits and implement corrective actions to maintain compliance.

5.6 Final Approval and Release

Once all GMP procedures have been followed and documented, the following steps should be taken:

1. QA Review
   1. The QA team reviews all GMP-related records, including batch records, equipment maintenance logs, and deviation reports, to ensure that the production process complies with GMP standards.
2. Approval for Release
   1. If the batch complies with GMP and all documentation is complete, the batch is approved for release and packaging.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• BPR: Batch Production Record

7. Documents

1. Training Log (Annexure-1)
2. Equipment Calibration Log (Annexure-2)
3. Maintenance Log (Annexure-3)
4. Production Monitoring Log (Annexure-4)
5. Deviation Log (Annexure-5)

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: Training Log

Employee Name	Training Date	Training Topic	Trainer	Sign-off
John Doe	02/01/2025	GMP Training	Jane Smith	✔

Annexure-2: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Result	Next Calibration Date	Operator
Filling Machine 001	01/02/2025	Pass	01/02/2026	John Doe

Annexure-3: Maintenance Log

Equipment ID	Maintenance Date	Maintenance Activity	Performed By	Next Maintenance Due
Sealing Machine 001	02/02/2025	Replaced sealing part	Jane Smith	02/02/2026

Annexure-4: Production Monitoring Log

Batch ID	Monitoring Date	Parameter Monitored	Result	Action Taken
Batch 001	01/02/2025	Capsule Weight	500 mg	None

Annexure-5: Deviation Log

Deviation ID	Batch ID	Deviation Description	Corrective Action Taken	Operator	Approval Status
DEV-001	Batch 001	Capsule weight outside acceptable range	Recalibrated machine	John Doe	Approved

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 compliance monitoring procedures	Standardization	QA Head