Standard Operating Procedure for Change Control in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to establish a systematic procedure for managing changes in transdermal patches production to ensure that all changes are properly reviewed, documented, and approved before implementation, thereby maintaining product quality, safety, and regulatory compliance.

2) Scope

This SOP applies to all changes that may affect the production, quality, and regulatory status of transdermal patches, including but not limited to equipment, facilities, materials, processes, and documentation within the production facility.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for overseeing the change control process. All departments involved in transdermal patches production are responsible for identifying and proposing changes, providing necessary documentation, and implementing approved changes.

4) Procedure

4.1 Change Request Initiation

• 4.1.1 Identify the need for a change and complete a Change Control Request (CCR) form, providing detailed information about the proposed change, including rationale and potential impact on product quality.
• 4.1.2 Submit the CCR form to the QA Department for initial review and logging into the Change Control Register.

4.2 Preliminary Assessment

• 4.2.1 Conduct a preliminary assessment of the proposed change to determine its potential impact on product quality, safety, regulatory compliance, and other critical aspects.
• 4.2.2 Assign a Change Control number and categorize the change based on its impact (e.g., minor, major, critical).

4.3 Change Control Committee Review

• 4.3.1 Convene a Change Control Committee (CCC) consisting of representatives from QA, Production, QC, Regulatory Affairs, and other relevant departments to review the proposed change.
• 4.3.2 Evaluate the change based on provided documentation, impact assessment, and any additional information required by the committee.
• 4.3.3 Approve, reject, or request further information/clarification regarding the proposed change.

4.4 Implementation Plan

• 4.4.1 For approved changes, develop an implementation plan detailing required actions, responsible personnel, timelines, and any necessary validation or verification activities.
• 4.4.2 Ensure all affected documents, such as SOPs, batch records, and validation protocols, are updated accordingly.

4.5 Implementation of Change

• 4.5.1 Execute the change according to the approved implementation plan, ensuring minimal disruption to ongoing operations and adherence to timelines.
• 4.5.2 Document all activities related to the implementation, including any deviations or issues encountered and their resolution.

4.6 Post-Implementation Review

• 4.6.1 Conduct a post-implementation review to verify that the change has been implemented as planned and has achieved the desired outcomes without adversely affecting product quality or compliance.
• 4.6.2 Document the review findings and obtain final approval from the Change Control Committee.

4.7 Change Control Closure

• 4.7.1 Update the Change Control Register to reflect the completion and closure of the change control process.
• 4.7.2 Retain all documentation related to the change control process as per company record retention policies and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
CCR: Change Control Request
CCC: Change Control Committee

6) Documents, if any

Change Control Request Form
Change Control Register
Implementation Plan
Post-Implementation Review Report

7) Reference, if any

ICH Q10: Pharmaceutical Quality System
21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

8) SOP Version

Version 1.0