Standard Operating Procedure for Change Control for FFS Machine
1) Purpose
The purpose of this SOP is to establish a systematic approach to managing changes related to the Form-Fill-Seal (FFS) machine to ensure continuity of production, product quality, and regulatory compliance.
2) Scope
This SOP applies to all changes impacting FFS machines, including modifications, upgrades, and replacements, within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Change Control Board
– Evaluate proposed changes to FFS machines and assess their potential impact on operations and product quality.
– Approve or reject change requests based on risk assessment and regulatory requirements.
3.2 Engineering Department
– Implement approved changes to FFS machines following validated procedures and protocols.
– Ensure all modifications are documented and communicated to relevant personnel.
3.3 Quality Assurance (QA) Personnel
– Review change control documentation and verify implementation of approved changes.
– Conduct periodic audits to assess compliance with change control procedures.
4) Procedure
4.1 Change Request Submission
4.1.1 Submit a Change Request Form detailing the nature and rationale for the proposed change to the Change Control Board.
4.1.2 Include supporting documents such as risk assessments, impact analyses, and validation plans as applicable.
4.2 Change Evaluation
4.2.1 The Change Control Board reviews the change request to determine its impact on FFS machine performance, product quality, and regulatory compliance.
4.2.2 Conduct risk assessment to identify potential risks associated with the proposed change.
4.3 Change Approval
4.3.1 Approve or reject the change request based on the assessment and recommendations of the Change Control Board.
4.3.2 Obtain necessary approvals from regulatory authorities, if required, before proceeding with implementation.
4.4 Change Implementation
4.4.1 Implement approved changes to FFS machines in accordance with validated procedures and protocols.
4.4.2 Document all modifications, including updated drawings, specifications, and equipment manuals.
4.5 Verification and Validation
4.5.1 Verify the effectiveness of implemented changes through testing, qualification, and validation activities.
4.5.2 Perform validation protocols and document results to ensure compliance with regulatory requirements.
5) Abbreviations, if any
– FFS: Form-Fill-Seal
– QA: Quality Assurance
6) Documents, if any
– Change Request Form
– Change Control Board Meeting Minutes
– Validation Reports for Implemented Changes
7) Reference, if any
– FDA Guidance for Industry: Changes to an Approved Application
– ICH Q10 Pharmaceutical Quality System
8) SOP Version
Version 1.0
