Elixir Department: SOP for Handling Deviations During Manufacturing – V 2.0

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Elixir Department: SOP for Handling Deviations During Manufacturing – V 2.0

Standard Operating Procedure for Handling Deviations During Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/076/2025
Supersedes SOP/ELX/076/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a systematic procedure for identifying, documenting, evaluating, and resolving deviations that occur during the manufacturing of elixir formulations, in compliance with current Good Manufacturing Practices (cGMP).

2. Scope

This SOP applies to all planned and unplanned deviations encountered during the execution of batch manufacturing, including process, equipment, material, environmental, and documentation-related events in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Immediately report any deviation observed during manufacturing.
    • Document the initial deviation details in the BMR and notify the supervisor.
  • Production Supervisor:
    • Evaluate the deviation and escalate it to QA for further investigation.
    • Assist QA in providing batch details, timings, and operator records.
  • QA Officer:
    • Initiate the Deviation Report, perform risk assessment, and determine batch disposition.
    • Ensure closure of deviation and implementation of CAPA (Corrective and Preventive Action).
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4. Accountability

The QA Manager is accountable for ensuring all deviations are thoroughly investigated, documented, closed within the

defined timeline, and that recurring issues are addressed through effective CAPA.

5. Procedure

5.1 Identification and Classification

  1. Deviation may be identified by:
    • Operator observation
    • Process alarms
    • In-process test results
    • QA inspections
  2. Classify deviation as:
    • Minor: No impact on product quality (e.g., documentation error, delay within limits)
    • Major: May affect product quality or GMP compliance (e.g., temperature excursion, incomplete mixing)
    • Critical: Confirmed or potential impact on patient safety or product integrity (e.g., wrong material addition, equipment failure)

5.2 Deviation Documentation

  1. Immediately stop the process (if required).
  2. Fill in the Deviation Report Form (Annexure-1) with:
    • Batch No., Date, Time, Stage, Description
    • Initial Action Taken
  3. Forward to QA for assessment and investigation.

5.3 Investigation and Impact Assessment

  1. QA initiates investigation with cross-functional team.
  2. Perform root cause analysis using appropriate tools (e.g., 5 Whys, Fishbone Diagram).
  3. Assess potential impact on:
    • Product Quality
    • Process Performance
    • GMP Compliance
    • Batch Disposition (Continue, Reprocess, Reject)
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5.4 Corrective and Preventive Actions

  1. Based on investigation, define CAPA plan:
    • Corrective Action: Immediate measure to eliminate the deviation.
    • Preventive Action: Steps to avoid recurrence (training, SOP revision, equipment change, etc.).
  2. Assign responsibilities and completion timelines.
  3. Track CAPA implementation and effectiveness.

5.5 Final Review and Closure

  1. QA shall review CAPA status, verify effectiveness, and authorize deviation closure in the Deviation Register (Annexure-2).
  2. Deviation shall be closed within 30 calendar days or as per risk classification.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • CAPA: Corrective and Preventive Action
  • GMP: Good Manufacturing Practice
  • BMR: Batch Manufacturing Record

7. Documents

  1. Deviation Report Form (Annexure-1)
  2. Deviation Register (Annexure-2)
  3. CAPA Action Plan (Annexure-3)

8. References

  • 21 CFR Part 211.100 – Written Procedures; Deviations
  • WHO TRS 986 – GMP Guidelines for Pharmaceuticals
  • ICH Q10 – Pharmaceutical Quality System
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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 ID Date Batch No. Description Initial Action Reported By
DEV-076-01 11/04/2025 ELX-1015 Agitation stopped abruptly Process paused Rajesh Kumar

Annexure-2: Deviation Register

Deviation ID Batch No. Date Type Status Closure Date Closed By
DEV-076-01 ELX-1015 11/04/2025 Major Closed 15/04/2025 Sunita Reddy

Annexure-3: CAPA Action Plan

Deviation ID Corrective Action Preventive Action Responsible Person Due Date Status
DEV-076-01 Reset control panel and restart after inspection Preventive maintenance schedule revised Maintenance Head 20/04/2025 Completed

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP QA Head
11/04/2025 2.0 Added CAPA Log and Risk Classification Regulatory Alignment QA Head
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