SOP for Management of Change in Pharmaceutical Manufacturing

1) Purpose

To establish a procedure for the management of change (MoC) in pharmaceutical manufacturing processes to ensure controlled implementation, evaluation, and documentation of changes that may impact product quality, safety, or efficacy.

2) Scope

This SOP applies to all changes initiated within the pharmaceutical manufacturing facility, including but not limited to process changes, equipment modifications, raw material substitutions, and procedural updates.

3) Responsibilities

Change Initiator: Responsible for initiating and documenting proposed changes.
Change Control Board (CCB): Responsible for reviewing, evaluating, and approving/rejecting proposed changes.
Quality Assurance: Responsible for oversight and compliance with MoC procedures.
Production Team: Responsible for implementing approved changes and conducting impact assessments.
Documentation Team: Responsible for maintaining records of all MoC activities.

4) Procedure

1. Change Proposal:
   1. Document the rationale, scope, and impact of the proposed change.
   2. Identify stakeholders and obtain necessary approvals.
2. Change Evaluation:
   1. Conduct a risk assessment to evaluate potential impact on product quality, safety, and efficacy.
   2. Review and assess regulatory compliance requirements.
3. Change Approval:
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   Present change proposal to the Change Control Board (CCB) for review and approval.

   Document CCB decision and rationale for approval or rejection.

   Implementation of Change:

   1. Develop an implementation plan detailing actions, timelines, and responsibilities.
   2. Execute approved changes in a controlled manner.

   Change Verification:

   1. Verify and confirm successful implementation of the change.
   2. Conduct post-implementation review and assessment.

   5) Abbreviations, if any

   MoC – Management of Change

   CCB – Change Control Board

   6) Documents, if any

   • Change Proposal Form
   • Risk Assessment Report
   • Change Control Board Meeting Minutes
   • Implementation Plan
   • Verification Report

   7) Reference, if any

   ICH Q10: Pharmaceutical Quality System

   8) SOP Version

   Version 1.0