SOP Guide for Pharma

Creams: SOP for Handling Deviations during Manufacturing – V 2.0

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Creams: SOP for Handling Deviations during Manufacturing – V 2.0

Standard Operating Procedure for Handling Deviations during Manufacturing

Department Creams
SOP No. SOP/CRM/058/2025
Supersedes SOP/CRM/058/2022
Page No. Page 1 of 6
Issue Date 12/12/2025
Effective Date 17/12/2025
Review Date 12/12/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the steps for handling deviations that may occur during the manufacturing process in the Creams Department. Deviations can arise due to unexpected changes in equipment, materials, or process conditions. This SOP ensures that all deviations are identified, assessed, documented, and resolved in a timely and systematic manner to prevent any negative impact on product quality, safety, and compliance with regulatory standards.

2. Scope

This SOP applies to any deviations that occur during the cream manufacturing process, including mixing, homogenization, packaging, and transfer operations. It covers the procedures for reporting, investigating, documenting, and implementing corrective and preventive actions (CAPA) to address deviations effectively.

3. Responsibilities

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4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that the deviation handling process is followed by all team members. The QA Manager is accountable for reviewing and approving deviation reports, corrective actions, and ensuring proper documentation for future audits.

5. Procedure

5.1 Identification of Deviations

  1. Deviations may be identified by the production team, QC team, or during routine process monitoring. These deviations may include:
    • Out-of-specification results from testing (e.g., pH, viscosity)
    • Unexpected changes in raw material characteristics
    • Malfunctions of equipment or machinery
    • Environmental control issues (e.g., temperature, humidity)
    • Human errors in the manufacturing process
  2. As soon as a deviation is identified, the production team must stop the process if necessary and notify the QA team immediately.

5.2 Reporting Deviations

  1. The production team should document the deviation using the Deviation Report Form (refer to Annexure-1) with detailed information, such as:
    • Description of the deviation
    • Time and date of occurrence
    • Area or batch affected
    • Immediate actions taken (e.g., stopping the process, securing the batch)
  2. The report must be submitted to the QA team for review and investigation.

5.3 Investigating Deviations

  1. The QA team is responsible for investigating the deviation. The investigation should include:
    • Root cause analysis to determine the underlying reason for the deviation
    • Assessment of the impact on product quality (e.g., was the product within specifications?)
    • Review of the manufacturing records and equipment logs for relevant data
  2. If necessary, involve the maintenance team, R&D, or other departments to investigate technical or equipment-related deviations.
  3. The investigation should be documented, and the findings should be communicated to the management team.

5.4 Corrective and Preventive Actions (CAPA)

  1. Based on the investigation findings, corrective actions should be implemented immediately to resolve the deviation and prevent its recurrence. These may include:
    • Adjustments to the manufacturing process
    • Repairs or calibration of equipment
    • Re-training of personnel if human error was identified as the cause
  2. The QA team should also define preventive actions to prevent future deviations. These may involve updating SOPs, improving quality control measures, or enhancing equipment maintenance procedures.
  3. Document all corrective and preventive actions taken, and include a timeline for their completion.
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5.5 Impact Assessment

  1. The QA team must assess the impact of the deviation on the affected batch of cream. This may involve additional testing (e.g., stability testing, microbial testing) to verify that the batch is still suitable for release.
  2. If the batch is found to be out of specification, the product may need to be rejected, reworked, or destroyed, depending on the severity of the deviation.
  3. If the batch is deemed acceptable, the QA team must approve it for release and ensure that all documentation is completed accurately.

5.6 Documentation of Deviations

  1. Complete documentation is critical for compliance with regulatory requirements and for maintaining traceability. The following documents must be maintained:
    • Deviation Report Form (Annexure-1)
    • Investigation Report
    • Corrective and Preventive Actions (CAPA) Log (Annexure-2)
    • Test results and impact assessment reports
  2. All deviation records must be signed by the responsible personnel and reviewed by the QA team.
  3. Store all deviation documentation securely for a minimum of the regulatory required retention period.

5.7 Follow-Up and Monitoring

  1. Once corrective actions have been implemented, monitor the affected process or equipment to ensure that the actions were effective and that no further deviations occur.
  2. If the corrective actions do not resolve the issue, a further investigation should be conducted, and additional measures should be taken to address the root cause.
  3. Regularly review past deviations to identify any trends or recurring issues, and take appropriate actions to prevent them from happening again.
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5.8 Final Approval

  1. After the deviation is fully investigated, documented, and corrective actions have been taken, the final report should be approved by the QA Manager.
  2. Once approved, the affected batch can proceed to the next stage, whether it be further processing or packaging.

6. Abbreviations

7. Documents

  1. Deviation Report Form (Annexure-1)
  2. CAPA Log (Annexure-2)
  3. Investigation Report (Annexure-3)

8. References

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 Form

Deviation Description Time Batch Number Operator Immediate Action
Out-of-specification pH level 10:30 AM 12345 John Doe Stop process, notify QA

Annexure-2: CAPA Log

Issue Root Cause Corrective Action Preventive Action Completion Date
High pH level Improper ingredient mixing Re-trained operators Review and revise SOPs 15/12/2025

Annexure-3: Investigation Report

Batch Number Deviation Description Findings Corrective Actions
12345 Out-of-specification pH level Improper mixing at specified temperature Re-trained team, updated SOPs

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
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