Achieving effective, repeatable, risk-based pharma change control
Most life sciences products continue to evolve long after approved formulations have entered the market, and all of these changes must be carefully tracked, managed and reported to maintain registrations, manufacturing transparency and patient safety.
In addition to updates to the product itself, or to the location or equipment used in manufacture, changes could result from revised regulatory or legal requirements, a response to quality issues, or corrective actions after an audit. Other changes may come from the business environment, or internal strategy.
Putting in appropriate change controls, guided via repeatable steps, also helps with identifying and containing any risk, which is important to maintain QA rigour and keep pace with legislation. It’s a fundamental expectation by regulators, in fact.
‘Change control’ refers to a systematic approach to managing all changes made to a product or a system – ensuring that no unnecessary changes are made; that all changes are documented; that manufacturing and distribution will not be unnecessarily disrupted; and that all resources are used efficiently. Usually, this will be handled within a pharmaceutical quality system.
All pharmaceutical regulatory guidelines, including Good Manufacturing/Distribution Practice (GMP/GDP), cover change management. They specify regulatory notification and approval where required, and the need for post-change evaluation – to confirm that quality objectives were achieved at that, and that there was no unintended impact on product quality.
Beyond satisfying regulators and keeping patients safe, effective change control leads to improved cost and risk avoidance associated with deviations, complaints, recalls. Being proactive in understanding and planning for the potential impact of future changes, meanwhile, can lead to smoother implementations. Future changes can be factored in with less disruption to the manufacturing schedule, for instance.
Conversely, a single inadequate change could lead to significant negative effects, including the release of a sub-standard product, potentially leading to product recall. A pattern of inadequate changes, meanwhile, could result in costly, time-consuming system remediation, not to mention the hidden costs of a loss of physician and patient confidence in the brand.
The more proactive, pre-emptive and methodical companies can be, the lower these risks.
What does good look like?
A systematic approach to change control will leave nothing to chance, boosted by timely notifications to teams to complete tasks promptly. A good system will allow this kind of workflow to be automated, in compliance with given parameters – so that the QMS system or equivalent software assigns tasks and issues notifications, without someone having to remember to do this.
So how can you evaluate the effectiveness of a risk-based change management system, if you’re implementing such a solution for the first time?
Here are some useful features and attributes to look out for:
- Controls to ensure that all proposed changes are formally evaluated, and a decision to accept or reject the proposal is documented, along with the related rationale.
- The objectives, scope and the expected outcomes/benefits of any changes should be detailed too, so look for a system that provides for all of this.
- The ability to include all relevant subject matter experts and appropriate internal or external stakeholders as applicable – those involved in the change proposal development and in the approval of the change.
- Any impact on pending or approved filings and regulatory commitments will need to be considered and addressed as an integral part of the change control process.
- Scope for risk-based classification, and support for a holistic impact assessment spanning product quality, documentation, cleaning, maintenance, regulatory compliance and so on.
- The change management system should ensure that appropriate science- and knowledge-based risk assessments, by the subject matter experts, are performed and documented.
- The level of formality and effort and documentation must be commensurate with the identified level of risk, both current and projected for the future.
Contributing to better output
Ultimately, change control is a quality system. It should never be reactive; rather it should be planned, intentional and purposeful, demonstrated via comprehensive documentation of decisions made and actions taken – and their justification. In fact, a good change management system should drive risk reduction to ensure better quality and manufacturing performance, boosted by continuous improvement and innovation.
But this also assumes that teams understand their own obligations, their respective roles and responsibility in evaluating changes properly and ensuring that the entire process is seen through properly, and that everyone buys into it.
Amplexor’s change control software provides the tools to monitor all types of changes that could influence the process, reliability or product quality; evaluate them in the context of regulatory requirements; and take them forward as appropriate, backed by appropriate documentation. Change information and approval within the system is transparent, and task tracking is intuitive and convenient, both for the manager and those performing the tasks.
We also provide a workspace for SOP management, for all kinds of actually quality documentation, and associated processes – such as deviation management, complaints, out of specification results, audits, CAPA management and supplier qualification.
In short, we’ve thought of everything so that you don’t have to.
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Life Science Consultant
About the author
Vanja Primorac is a life science consultant and QA specialist at Amplexor in Zagreb, Croatia, contributing to the development of and enhancements to the company’s software. A qualified pharmacist, she previously worked at GlaxoSmithKline as a QA Responsible Person and Senior Quality Executive.