Understanding change management
In pharmacy aseptic services, any change – whether to equipment, process, facility, or documentation – has potential consequences for patient safety because of changes to product or service quality.
A formal change management process provides a structured way to introduce improvements safely. It helps aseptic teams to understand the impact of a proposed change, implement it in a controlled manner, and demonstrate that risks have been addressed. Robust change management is an essential component of a pharmaceutical quality system (PQS), reducing the likelihood of errors, interruptions in service, or unintended effects on product quality.
For more information about quality in aseptic services, including pharmaceutical quality systems, refer to the article series on understanding aseptic services in the NHS (SPS page).
The change management process
The International Council for Harmonisation (ICH) Pharmaceutical Quality Systems guidance, ICH Q10, identifies change management as one of the key elements of a robust PQS. It sets out how organisations should evaluate, approve, and implement changes in a systematic way.
Using a structured framework promotes reliable decision making and effective control throughout the change lifecycle.
Change management should always be supported by standard operating procedures (SOPs) and associated forms, appropriate to the type of change. A general change management SOP and form will be used for most changes, for example introduction of a new disinfectant. Specific types of changes, such as introduction of a new product, may be supported by a more specific SOP and form.
The stages below outline a consistent pathway, with clear roles, defined activities and approvals.
Identify and propose a change
The process begins when a need or opportunity for change is identified. This might relate to improving efficiency, addressing a compliance requirement, updating equipment, significant changes to staffing or responding to a service risk. Change management should be proactive, with proposed changes documented and approved before implementation. Any member of staff should be able to propose a change.
A well‑defined change proposal should include:
• a change reference number and date opened
• categorisation of the type of change, for example, facilities or equipment
• a clear description of what is being changed and how it differs from the current process
• the reason for the change and its objective
• the name of the proposer
Early clarity ensures the change can be assessed and implemented in a structured, risk-based way. All proposed changes must be recorded, regardless of whether they are later accepted or rejected.
Assess the impact
An impact assessment evaluates how the proposed change might affect product quality, patient safety, service delivery, and regulatory compliance. It should consider the four Ps (people, premises, processes, and product), as well as wider factors such as impact on customers, stakeholders, finance or sustainability.
Key activities include:
• reviewing potential risks and consequences
• assessing the need for validation, training, or updated documentation
• considering impacts on environmental conditions, workflows, and staffing
In aseptic services, this step is critical because even small changes, such as adjusting a cleaning agent or modifying a worksheet, can influence product quality.
Following the impact assessment, the change should be formally reviewed by an appropriate person. The decision to accept or reject the change must be documented with clear rationale.
Plan
Once the change has been assessed, a clear plan is created to describe how the change will be managed and the controls required. The plan should be SMART (specific, measurable, attainable, relevant and time based) to ensure the change proceeds in a controlled, predictable way and that all affected parties understand what is required.
A typical plan includes:
• defined actions and responsibilities
• timelines and resource requirements
• acceptance criteria
The plan should consider any required validation or qualification steps, any changes to documentation or procedures and communication or training needs.
After the plan is prepared, it should be formally reviewed and approval to proceed documented.
Implement
The approved change is implemented following the agreed plan.
Implementation should:
• follow the documented procedure
• record all actions, evidence, completion dates, and results
• measure effectiveness against the acceptance criteria
• review whether any adverse impact or increased risk has occurred
During implementation of a change, it is essential to be continuously alert for unanticipated consequences or non-compliance with the new process.
Once implementation is complete, it should be formally reviewed and approval documented. This step provides data and information needed to fully review the effectiveness of the change.
Monitor
After the change is live, the unit monitors its performance as defined during the planning stage. This confirms that everything is functioning as intended and that no new risks have emerged.
Monitoring may include
• operator and supervisor feedback
• environmental or physical monitoring trends
• deviations and near‑miss data
• quality and performance indicators
• audit and compliance checks
This step provides more data and information for review.
Review effectiveness
This review evaluates whether the change has achieved its purpose.
The review may consider:
• whether objectives have been met
• impacts on workflow, quality, or patient safety
• whether the change is fully understood and embedded
• ongoing issues requiring follow‑up
If further action is needed it may be necessary to return to an earlier step in the change process before proceeding to closure.
Close
Once the change has been validated, monitored, and reviewed, it is formally closed.
Documentation should show:
• actions completed
• evidence reviewed
• approvals obtained
Documents should make reference to other records, such as deviations, monitoring results or meeting minutes, to ensure all relevant information is readily available when the change is reviewed in future.
Closure confirms that the change is complete and has been fully embedded into the quality system. Lessons learned should be documented as part of ongoing quality improvement.
Other resources
Refer to the video about change management for aseptic services (SPS page) for additional information about change management in practice.