Standard Operating Procedure for Change Control Procedures in Ointment Formulation

1) Purpose

The purpose of this SOP is to establish procedures for managing changes in ointment formulation processes, equipment, facilities, or documentation to ensure control, evaluation, and approval of changes in accordance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in initiating, assessing, implementing, and verifying changes related to ointment formulation processes, equipment, facilities, or documentation.

3) Responsibilities

– Change Control Board: Responsible for evaluating and approving proposed changes.
– Quality Assurance (QA): Responsible for ensuring changes are implemented in compliance with SOPs and regulatory requirements.
– Department Heads: Responsible for initiating and documenting proposed changes.

4) Procedure

1. Change Proposal:
1.1 Initiation:
1.1.1 Identify the need for a change and document the rationale for the proposed change.
1.1.2 Complete a change request form outlining the scope and impact of the proposed change.

1.2 Evaluation:
1.2.1 Review proposed changes for potential impact on product quality, safety, or efficacy.
1.2.2 Assess resources required and feasibility of implementing the proposed change.

2. Change Approval:
2.1 Change Control Board Review:
2.1.1 Submit the change request to the Change Control Board for review and approval.
2.1.2 Document decisions made by the Change Control Board and reasons for approval or rejection.

2.2 Approval Notification:
2.2.1 Notify stakeholders of approved changes and provide instructions for implementation.
2.2.2 Obtain necessary signatures and approvals before proceeding with implementation.

3. Implementation:
3.1 Planning:
3.1.1 Develop an implementation plan detailing steps, responsibilities, and timelines.
3.1.2 Allocate resources and assign tasks to ensure smooth implementation.

3.2 Execution:
3.2.1 Implement changes under controlled conditions, following approved procedures.
3.2.2 Monitor implementation progress and address any issues or deviations promptly.

4. Verification and Validation:
4.1 Effectiveness Verification:
4.1.1 Verify the effectiveness of implemented changes through testing, inspections, or reviews.
4.1.2 Document verification activities and results for future reference.

4.2 Validation Requirements:
4.2.1 Perform validation activities if changes affect product quality, safety, or efficacy.
4.2.2 Ensure validation protocols are approved and followed according to regulatory requirements.

5. Documentation and Closure:
5.1 Documentation Updates:
5.1.1 Update relevant documents (e.g., SOPs, batch records) to reflect approved changes.
5.1.2 Archive change control documentation and maintain records for audit purposes.

6. Roles and Responsibilities:
6.1 Change Initiator:
6.1.1 Identify and initiate changes based on operational needs or improvements.
6.1.2 Ensure all required documentation is complete and accurate.

7. Change Control Board Review:
7.1 Evaluation of Proposed Changes:
7.1.1 Review proposed changes for potential impact on product quality, safety, or efficacy.
7.1.2 Evaluate the feasibility of proposed changes and resources required.

8. Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure

9. Documents, if any
– Change Request Forms
– Change Control Board Meeting Minutes
– Implementation Plans

10. Reference, if any
– FDA Current Good Manufacturing Practice (CGMP) Regulations
– ISO 13485:2016 Medical devices – Quality management systems

11. SOP Version
Version 1.0