Change Control Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for change control in metered-dose inhaler (MDI) production to manage and document changes to processes, equipment, facilities, and systems in a controlled manner to ensure product quality, safety, and efficacy.

2) Scope

This SOP applies to all personnel involved in change control activities within the MDI production facility, including change control board members, quality assurance personnel, production managers, and regulatory affairs specialists.

3) Responsibilities

The responsibilities for this SOP include initiating change requests, evaluating change impacts, implementing changes, and verifying effectiveness. Specific roles include:
Change Control Board Members: Review and approve change requests based on impact assessments.
Quality Assurance Personnel: Ensure changes comply with regulatory requirements and quality standards.
Production Managers: Implement approved changes and monitor their impact on production processes.
Regulatory Affairs Specialists: Ensure documentation and communication of changes to regulatory authorities as required.

4) Procedure

4.1 Change Request Initiation
4.1.1 Identify the need for a change and document the rationale for the change request.
4.1.2 Complete the change request form, including details such as change description, justification, and potential impact assessment.
4.2 Change Evaluation
4.2.1 Review change requests by the Change Control Board (CCB) to assess impacts on product quality, safety, efficacy, and regulatory compliance.
4.2.2 Conduct risk assessments and determine validation requirements for significant changes.
4.3 Change Implementation
4.3.1 Develop an implementation plan outlining tasks, timelines, and responsible personnel.
4.3.2 Execute changes following approved procedures and update relevant documents (e.g., SOPs, batch records).
4.4 Verification and Validation
4.4.1 Verify completion of change implementation and conduct validation activities as required.
4.4.2 Ensure effectiveness of changes through monitoring and assessment of post-implementation results.
4.5 Documentation and Communication
4.5.1 Document all change control activities, including change requests, evaluations, approvals, and implementation details.
4.5.2 Communicate changes to relevant personnel and stakeholders as appropriate.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
CCB: Change Control Board

6) Documents, if any

Change request forms, change control logs, implementation plans, validation reports, and communication records should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for change control requirements in pharmaceutical manufacturing.

8) SOP Version

Version 1.0