Standard Operating Procedure for Documentation of Process Deviations in Capsule Production

Department	Production
SOP No.	SOP/PD/221/2025
Supersedes	SOP/PD/221/2022
Page No.	Page 1 of 5
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to outline the process for documenting and managing process deviations in capsule production. Ensuring that all deviations are identified, documented, and reviewed helps maintain product quality, safety, and compliance with GMP and regulatory requirements.

2. Scope

This SOP applies to the documentation of any process deviations that occur during the production of capsules, including manufacturing, filling, sealing, and packaging stages. It applies to all personnel involved in capsule production and quality control.

3. Responsibilities

• Production Team: Responsible for identifying and reporting process deviations during production activities.
• Quality Control (QC) Team: Responsible for reviewing the deviation reports and verifying the impact of the deviation on product quality.
• Quality Assurance (QA) Team: Responsible for evaluating deviations, implementing corrective actions, and ensuring proper documentation of the deviation process.
• Deviation Owner: Responsible for investigating the cause of the deviation and ensuring corrective actions are implemented.

4. Accountability

The Production Manager is accountable for ensuring that deviations are promptly identified and reported. The QA Manager is responsible for overseeing the investigation, corrective actions, and ensuring that all deviations are properly documented and reviewed.

5. Procedure

5.1 Identification of Process Deviations

Follow these steps when a process deviation is identified:

1. Monitor Production Activities
   1. Production personnel should continuously monitor manufacturing, filling, and packaging processes for any deviations from standard procedures or specifications.
   2. If any irregularities or non-conformances are observed, the production team must immediately identify the deviation and stop the process if necessary to prevent further impact on the batch.
2. Report Deviation
   1. Immediately report the deviation to the QA team and document the incident in the Deviation Report Log (refer to Annexure 1).
   2. Ensure that the report includes the batch number, product name, the specific deviation observed, and the impact on production.

5.2 Investigation of Deviations

Once a deviation is reported, follow these steps for investigation:

1. Root Cause Investigation
   1. The QA team will work with the production team to investigate the root cause of the deviation. This includes reviewing production records, equipment logs, and raw material information.
   2. Interview relevant personnel and observe the production process to gather additional information related to the deviation.
2. Assess the Impact
   1. The QA team will evaluate the impact of the deviation on product quality and compliance. Determine whether the deviation affects the product’s safety, efficacy, or regulatory status.
   2. If necessary, determine whether the batch should be placed on hold, reworked, or rejected based on the severity of the deviation.

5.3 Corrective and Preventive Actions

After identifying the root cause, implement corrective and preventive actions:

1. Corrective Actions
   1. Develop and implement corrective actions to address the root cause of the deviation and prevent recurrence. Corrective actions may include retraining personnel, adjusting equipment settings, or modifying procedures.
   2. Document corrective actions in the Deviation Report Log and assign responsibility for implementation.
2. Preventive Actions
   1. Implement preventive actions to minimize the risk of similar deviations in the future. Preventive actions may involve revising standard operating procedures (SOPs) or introducing additional controls or checks.
   2. Monitor the effectiveness of preventive actions to ensure they prevent the recurrence of the deviation.

5.4 Documentation and Reporting

Document all process deviations thoroughly:

1. Complete Deviation Report
   1. Ensure that the Deviation Report includes all relevant details, including the deviation description, root cause analysis, corrective and preventive actions, and impact on the batch.
   2. The Deviation Report should be signed off by the QA team and the responsible personnel.
2. Submit to QA for Approval
   1. The completed Deviation Report is submitted to the QA Manager for review and approval. QA will ensure that the deviation is adequately addressed and that the corrective actions are implemented.
3. Store Deviation Records
   1. Store all deviation records in a secure and organized location for future reference and audits.
   2. Ensure that deviation records are retained according to regulatory requirements (typically 5 years or as per local regulations).

5.5 Review and Monitoring

After the corrective actions have been implemented, follow these steps:

1. Monitor Effectiveness
   1. Monitor the effectiveness of corrective actions to ensure that the deviation does not recur.
   2. Conduct periodic reviews of deviations to identify any recurring issues or patterns that may require further corrective actions.
2. Periodic Audits
   1. Conduct regular audits of the deviation process to ensure compliance with this SOP and regulatory requirements.
   2. Ensure that all deviations are documented and reviewed in a timely manner.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record
• CoA: Certificate of Analysis

7. Documents

1. Annexure 1: Deviation Report Template
2. Annexure 2: Corrective Action Plan
3. Annexure 3: Root Cause Analysis Template

8. References

• Good Manufacturing Practice (GMP) Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Deviation Report Template

Deviation ID	Batch Number	Deviation Date	Deviation Description	Root Cause	Corrective Action	Preventive Action	Approval Status
DEV-001	Batch 001	01/03/2025	Temperature deviation during sealing	Improper machine calibration	Re-calibrate sealing machine	Implement more frequent machine checks	Approved

Annexure 2: Corrective Action Plan

Action ID	Action Description	Responsible Person	Completion Date	Status
CAP-001	Re-calibrate sealing machine	John Doe	05/03/2025	Completed

Annexure 3: Root Cause Analysis Template

Root Cause	Investigation Details	Corrective Action Taken
Improper machine calibration	Inspection of machine logs revealed irregular calibration data.	Machine recalibrated and checked for consistency.

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for documenting deviations	QA Head
01/02/2025	2.0	Updated deviation investigation process	Added corrective and preventive action documentation	QA Head