Elixir Department: SOP for Change Control Procedure – V 2.0

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Elixir Department: SOP for Change Control Procedure – V 2.0

Standard Operating Procedure for Change Control Procedure in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/244/2025
Supersedes SOP/ELX/244/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define a formal system for initiating, evaluating, approving, implementing, and reviewing changes that may impact the quality, safety, or efficacy of elixir products and associated processes in compliance with cGMP and regulatory expectations.

2. Scope

This SOP applies to all proposed changes related to facilities, utilities, equipment, materials, documents, processes, test methods, and computer systems involved in elixir manufacturing, testing, and distribution.

3. Responsibilities

  • Initiator (Any Department):
    • Identify the need for change and fill out the Change Control Request Form (Annexure-1).
  • Department Head:
    • Perform initial assessment of proposed change and submit for QA review.
  • QA Officer:
    • Assign change control number, perform risk assessment, and coordinate cross-functional review.
  • Change Control Committee (CCC):
    • Evaluate and approve/reject major changes after full impact assessment.
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4. Accountability

The QA Head is accountable for maintaining the change control system, ensuring timely execution, documentation, and regulatory compliance.

5. Procedure

5.1 Types of Change

  • Minor Change: Change with minimal impact, e.g., equipment ID renumbering, editorial document corrections.
  • Major Change: Change with potential regulatory, product quality, or validation impact, e.g., formulation modification, facility layout redesign, vendor replacement.

5.2 Change Request Initiation

  1. The initiator fills the Change Control Request Form (Annexure-1) and submits it to QA.
  2. QA assigns a unique Change Control Number (e.g., CC/ELX/2025/001) and logs in Change Control Register (Annexure-2).

5.3 Impact Assessment

  1. QA coordinates with affected departments (Production, QC, Engineering, Regulatory, IT) to perform impact assessment.
  2. Evaluate impact on:
    • Product quality and safety
    • GMP compliance
    • Validation status
    • Regulatory filings
    • Training and documentation

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5.4 Approval

  1. Minor changes may be approved by QA and department head.
  2. Major changes must be reviewed by the Change Control Committee (CCC) and require QA Head approval.

5.5 Implementation

  1. Assigned teams execute the change as per action plan and timelines.
  2. Update impacted SOPs, protocols, validation documents, and train concerned personnel.

5.6 Verification and Closure

  1. QA verifies implementation and supporting documents.
  2. Post-change review is conducted to confirm intended outcomes.
  3. QA signs off the closure section of Change Control Form.

5.7 Change Control Metrics

  1. QA shall review monthly open and closed changes, and include data in quality metrics.
  2. Delayed closures must be escalated with justification to senior QA.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • CCC: Change Control Committee
  • GMP: Good Manufacturing Practice

7. Documents

  1. Change Control Request Form (Annexure-1)
  2. Change Control Register (Annexure-2)
  3. Risk Assessment Worksheet

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8. References

  • ICH Q10 – Pharmaceutical Quality System
  • 21 CFR Part 211.100 – Written Procedures and Change Control
  • WHO Technical Report Series No. 986 – Annex 2

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Change Control Request Form

Change Control No. Date Initiator Department Description of Change Type (Minor/Major)
CC/ELX/2025/001 11/04/2025 Rajesh Kumar Production Change in elixir batch size from 500L to 600L Major

Annexure-2: Change Control Register

Change No. Date Department Status Implementation Date Closed By
CC/ELX/2025/001 11/04/2025 Production Closed 20/04/2025 Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP Creation QA Head
11/04/2025 2.0 Updated with CCC involvement and minor/major classification Compliance with ICH Q10 QA Head
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