Auditing a Change Management System

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Goals When you have completed this unit, you should be able to: · Perform an audit of a change management system. · Use a range of tools and information, including the contents of this unit and the internet to support the audit of a change management system. · Understand and apply appropriate GMP standards/regulations to an audit of a change management system. · Recognize compliance or non-compliance of a change management system to applicable regulations.

Definitions Change Control: A formal process by which qualified representatives of appropriate disciplines review (including technical and operational impact assessment), authorize, approve and close proposed or actual changes to facilities, systems, equipment and processes to ensure that they are maintained in a controlled manner.

Explanation of Topic Introduction Planned changes may be proposed to a starting material, product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or reproducibility of the process. Written procedures should be in place to describe the actions to be taken if such a change is proposed. Change control procedures should ensure that sufficient supporting data are generated to demonstrate that the revised process will result in a product of the desired quality, consistent with the approved specifications. All changes that may affect product quality or reproducibility of the process should be formally requested, documented and accepted. The likely impact of the change of facilities, systems and equipment on the product should be evaluated, including risk analysis. The need for and the extent of re-qualification and re-validation should be determined and the rationale captured in the documentation. Basic Components of a Change Management System If a piece of equipment or a process needs to be modified, it should follow an established and approved change control process as outlined in a detailed approved procedure. This procedure should include direction and guidance and answer the following questions: Ø What is the proposed change? Ø How will it be implemented? Ø Who are the necessary parties to approve it?

Auditing a Change Management System

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Ø Whether the change requires validation or stability studies Ø Risk assessment of the change Ø Date of submission of change form Ø Regulatory assessments Ø Implementation information (date, dependencies) Ø Impact on product supply Ø Multiple/cross-site Impact Ø Assessment to packaging and labeling Additional information may also be needed: Ø A description of the status of the facility, process, equipment without the change Ø Available alternatives for the change Ø Approval by a global or executive group if the change will impact various sites and has worldwide ramifications. Ø Any necessary documents, prints, studies, position/concept papers, data to support the change. Ø Subsequent change assessment Systems may require implementation information (i.e., date of change, first batch impacted, etc.) as part of the change documentation. Depending on the policy of the site, changes may be combined (“bundled”), for example, if multiple systems are impacted, the system changes may be bundled. Change Approval All changes that are GMP related are to be approved by a representative of quality assurance. While it is responsible for approving all changes, Quality Assurance is not necessarily responsible for coordination of the change. Approvals may vary based on the type, classification and the location of the change. The change must be evaluated to determine appropriate groups involved are informed and communicated about the change and are given appropriate information. Change Coordinators and Initiators are usually the individuals who use the process or are impacted by the change and are usually the persons responsible to present and evaluate the change. They are responsible to provide the information associated with the proposed change. This includes providing clear, documented descriptions, assessments and providing clarifications if needed. In addition, they are responsible to determine appropriate approvers who would be applicable to evaluate the change from a regulatory impact, impact on validated systems and departmental impact. Approvers should work with the Change Coordinators. Their responsibility is to evaluate and analyze the content of the proposed change, be sure the change and it’s technical aspects are clearly stated, that it involves the appropriate actions and is all inclusive of all processes/systems affected. They are expected to critique for clarity and state relevant comments. Approvers are those individuals with authority to accept or reject the change. As an approver, they have three responsibilities. The first is that they accept the concepts,

Auditing a Change Management System

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Key Parameters in Auditing a Change Management System Prior to the Audit · Review the inventory list of the site’s critical equipment, instruments and systems and determine if there have been changes to them. · Determine if there are any outstanding corrective actions from either internal audits or regulatory inspections involving change management. During the Audit · Ensure that any change made to facilities, equipment, materials, processes, documents or informational technology is part of a site’s change management program. Ø Verify that there is a written policy, guidance or procedure in place that identifies all aspects of the change management program. Ø If more that one change management system exists, determine what system governs what type of change and how they are connected.. Ø Determine if the site has different levels of changes.

• Ensure that there is a procedure that identifies the activities for each level of change.

• Ensure that there is appropriate documentation for each level of change. Ø Determine if there is a standard method of approval for documents and that the approval process is documented. Ø Ensure that if changes are made to the proposed original change after the review process, that the revised changes are documented. Ø Verify that GMP changes are approved by the Quality group. Ø Verify that no change, with potential regulatory impact, is implemented until it has been approved by regulatory affairs. Ø Verify that changes requiring regulatory approval do not progress prior to receiving regulatory approval. Ø Ensure that there is a list of approvers or approver titles for various levels of change. Ø Ensure the supplier or contractor as part of the change management process include a step for approval or notification to the sponsor company of changes to manufacturing, specification or testing requirements Ø If approvers have delegated their authority to another individual, ensure that there is a memo reflecting this. Ø Ensure that if changes are made to the change approval process that they are documented. Ø Ensure that there is a method to coordinate a change in all affected documents. Ø If the same product is produced at multiple sites, determine how each site is notified and the change is implemented. Ø If a change has been made to an electronic system, ensure that training on the system has taken place. Ø Determine what the site’s procedure is on bundling changes. Ø Verify that the status of changes is tracked and accessible. Ø Determine if there is more than one level of approving bodies for a change, e.g.