Standard Operating Procedure for Change Management System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a systematic Change Management System (CMS) to ensure that changes to processes, equipment, facilities, or systems related to the manufacturing of ocular dosage forms are evaluated, controlled, and implemented in a controlled manner to prevent adverse impacts on product quality and regulatory compliance.

2) Scope

This SOP applies to all changes that may impact the quality, safety, efficacy, or regulatory compliance of ocular dosage forms, including eye drops, ointments, gels, and inserts. It covers changes initiated by internal assessments, regulatory requirements, corrective actions, preventive actions, and continuous improvement initiatives.

3) Responsibilities

The Change Control Board (CCB) is responsible for overseeing the change management process. The Quality Assurance (QA) department coordinates the evaluation and approval of changes. Department heads and personnel are responsible for initiating and documenting changes, while the management team ensures resources are allocated for implementation.

4) Procedure

4.1 Change Initiation

1. Identify the need for change through internal assessments, audits, corrective actions, preventive actions, or regulatory updates.
2. Document the change request using the Change Request Form, detailing the nature and justification for the change.

4.2 Change Evaluation

1. Convene the CCB to review the change request, assessing its impact on product quality, safety, efficacy, regulatory compliance, and business processes.
2. Assign a risk assessment to determine the level of scrutiny required for the change evaluation.
3. Verify that the proposed change aligns with current SOPs, regulatory requirements, and quality standards.

4.3 Change Approval

1. Obtain approval from the CCB based on the evaluation and risk assessment.
2. Document the approval decision and communicate it to relevant stakeholders.

4.4 Change Implementation

1. Develop an implementation plan outlining tasks, timelines, responsibilities, and resource requirements.
2. Execute the change according to the approved plan, ensuring proper training and communication to affected personnel.
3. Monitor the implementation progress and address any deviations promptly.

4.5 Change Verification

1. Verify the effectiveness of the change through follow-up assessments, testing, or validation activities as applicable.
2. Document verification results and ensure they meet predefined acceptance criteria.

4.6 Change Closure

1. Close the change request once implementation and verification are complete.
2. Archive relevant documentation, including updated SOPs, training records, and validation reports.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CMS: Change Management System
CCB: Change Control Board
QA: Quality Assurance

6) Documents, if any

1. Change Request Form
2. Change Evaluation Report
3. Change Approval Documentation
4. Implementation Plan
5. Verification and Validation Reports
6. Training Records

7) Reference, if any

Good Manufacturing Practices (GMP) guidelines
International Conference on Harmonization (ICH) guidelines Q10
Company-specific quality policies and procedures

8) SOP Version

Version 1.0