Change management is defined in ICH Q10 as a systematic approach to proposing, evaluating, approving, implementing, and reviewing changes. A disciplined approach to change is a critical component of regulatory, quality, and compliance management in the life sciences industry. In such a heavily regulated industry, your change management for regulatory compliance process needs to be strategic and able to accommodate all of the different changes that occur across many different areas. Change management applies across the entire product lifecycle.
A formal change management system should be utilized whenever there is a change to process or when there are procedures that could impact your operations in a good manufacturing practice (GMP) environment. This could include changes to facilities, utilities, equipment, instruments, processes, materials, and controlled documents (e.g., SOPS, work instructions, product or material specifications, submission documents, stability protocols, etc.).
Elements of a Change Management Process
Change management for regulatory compliance requires a purposeful transition from a previously validated state to a new one and provides a high degree of assurance that there are no unintended consequences of the change. Key requirements include:
- Quality risk management is needed to evaluate proposed changes, with the level of effort and formality commensurate with the level of risk of the change.
- Proposed changes must be evaluated with respect to standards of practice, compliance policies, marketing authorization, regulatory notification and approvals, product and process understanding, and/or design space.
- Subject matter experts and cross functional teams with appropriate expertise, knowledge, and experience should evaluate proposed changes to ensure the change is technically justified and the implementation plan is complete.
- Test and validation requirements must be identified and planned for to ensure the validation state of the process after the change is implemented.
- After completion of the implementation of the change, an evaluation must be done to assure that the change objectives were achieved, with no unexpected results.
An effective change management system will include the following steps in order to provide a structured approach for the identification, preparation, evaluation, review, implementation, and verification of changes in a GMP environment.
- Identify the need for change. The need to make a change is identified based on process improvement, corrective actions to resolve a deviation, change in regulatory requirements, raw material changes, etc.
- Submit request for change. The change request must be documented to include the justification for the change, as well as the current “as is” condition and the proposed “to be” condition. This is then submitted to the Change Review Board for evaluation.
- Review change request. The request is then reviewed for impact by all concerned departments. This includes the assessment of risk, regulatory assessment, development of implementation plans and contingency plans, testing and validation requirements, required documentation updates, and identification of any additional activities resulting from the implementation of the change
- Discussion by Change Review Board. The Change Review Board meets to review and evaluate the impact of the change and assure all plans are clearly defined. At this time, if there are any questions or concerns about the evaluations or plans, they are discussed with the team. Revisions of plans are made as needed.
- Approval of the change request. If all parties have agreed that the change plan is appropriate, the request is approved and can be implemented.
- Implementation of the change. The change is implemented according to the plans, including any test and validation requirements
- Effectiveness check. After the change is implemented, the change is monitored and evaluated to review and report on the results of the change and its effects.
Change Management Team
As the Change Review Board has a critical role in evaluation of the change and development of change management plans, the selection of the appropriate participants on the Change Review Board and the change management team is crucial to a proper evaluation and implementation of changes.
It’s suggested that an assembled Change Review Board be led by a few highly respected senior managers and supported by process experts and subject matter experts, as well as change management professionals to help guide the process. Assigning too few or misaligned experts leads to incomplete and less-than-thorough evaluation of changes.
Therefore, the following roles should be included as part of your change management team:
- Highly respected senior managers (sponsors) with authority to approve changes and to set the tone for the importance of the change management process. It has been shown that assigning too few senior participants conveys a message that change management isn’t a high priority.
- Subject matter and process experts (advocates) to ensure that required elements of the current state will be integrated into the new state, and to provide their expertise to analyze the impact of the proposed change.
- Change management professionals (project managers) to manage the change process, document the decisions, manage the change plans, and guide the team through the process.
Importance of Change Management for Regulatory Compliance
Having control of your change management process is a critical component of compliance in a life sciences company. It’s important to rigorously evaluate, plan for, implement, and document changes to any process or system in a GMP environment. Clarkston has experienced change management leaders, project managers, and subject matter experts who can support you as you implement changes in your processes.
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