Standard Operating Procedure for Change Control Procedures in Ointment Formulation
1) Purpose
The purpose of this SOP is to establish a formal process for managing changes in the ointment formulation process to ensure that all changes are reviewed, approved, and implemented in a controlled manner, maintaining product quality and regulatory compliance.
2) Scope
This SOP applies to all changes that may impact the quality of ointments, including changes to equipment, processes, raw materials, and documentation. It covers the procedures for initiating, evaluating, approving, and implementing changes.
3) Responsibilities
– Change Control Committee: Responsible for evaluating and approving proposed changes.
– Department Heads: Responsible for initiating change requests and ensuring their proper documentation.
– Quality Assurance (QA): Responsible for overseeing the change control process and ensuring compliance with SOPs and regulatory requirements.
4) Procedure
1. Initiating a Change Request:
1.1 Change Request Form:
1.1.1 Complete a Change Request Form detailing the proposed change.
1.1.2 Include a description of the change, rationale, impact assessment, and proposed implementation plan.
1.2 Submission:
1.2.1 Submit the completed Change Request Form to the Change Control Committee.
Evaluating the Change Request:
2.1 Impact Assessment:
2.1.1 Assess the potential impact of the proposed change on product quality, safety, and regulatory compliance.
2.1.2 Conduct risk assessments as necessary.
2.2 Review by Change Control Committee:
2.2.1 The committee reviews the change request and impact assessment.
2.2.2 Approve, reject, or request additional information regarding the proposed change.
Implementing the Approved Change:
3.1 Implementation Plan:
3.1.1 Develop a detailed implementation plan, including timelines, responsibilities, and required resources.
3.1.2 Communicate the plan to all affected departments.
3.2 Execution:
3.2.1 Execute the change according to the approved plan.
3.2.2 Monitor and document the implementation process.
Post-Implementation Review:
4.1 Verification:
4.1.1 Verify that the change was implemented as planned and that it achieved the desired outcome.
4.1.2 Conduct any necessary testing to confirm the effectiveness of the change.
4.2 Documentation:
4.2.1 Update relevant documents (e.g., SOPs, batch records) to reflect the change.
4.2.2 Maintain all change control records for audit and inspection purposes.
5) Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure
6) Documents, if any
– Change Request Forms
– Impact Assessments
– Implementation Plans
– Change Control Logs
7) Reference, if any
– FDA Guidance for Industry: Q10 Pharmaceutical Quality System
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0