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December 08, 2021

Good Manufacturing Practices (GMP) are built on documentation. A common adage in this field is: “if you didn’t document it, it didn’t happen.” Change control systems provide a prescribed way to document alterations, adjustments, and modifications, no matter how big or small. Change control must be applied to every aspect of GMP to ensure that a facility and the products it produces are compliant with regulatory standards. In a GMP facility, change control is a key aspect of quality management systems and is overseen by the quality assurance team.  

How Can a Deviation Trigger a Change Control?  

The operation of a GMP facility, and the manufacturing processes that are carried out, are governed by Standard Operating Procedures (SOPs). A deviation occurs any time an SOP cannot be strictly adhered to. All deviations are documented as incidents. Incidents will trigger investigations that may or may not lead to a change control. Investigations, which can take up to 30 days, are aimed at determining the root cause of a deviation and will have different outcomes depending on the findings. In some cases, an investigation will show that a deviation was planned and necessary; in that case, a change control to modify or improve an SOP will be submitted. When an investigation determines that a deviation is significant, it will trigger a corrective action and preventive action (CAPA) that could also lead to a change control. It is important to remember that change controls always require justification based on evidence. All change controls must be vetted by the Quality team. In some cases, change controls need to be assessed by the regulatory team to ensure that, if implemented, they will not affect compliance with regulatory standards.   

How Can an Audit Trigger a Change Control?  

GMP facilities are subject to audits by potential clients and regulators. Audits return observations that can be dealt with through change controls. An audit report will provide justification for why a change control was completed or not. When a client is actively working in a GMP facility, they can review and approve change controls that might affect their final product. 

 

How Are Change Controls Implemented? 

It is expected that SOPs will change and ideally improve over time. This necessary change is supported by and documented in change controls. A change proposal will be prepared to initiate a change control. The change proposal is assessed to determine the impact of a change and the actions required to achieve it. If the proposal is approved, it will be implemented by following the actions set out during the assessment stage.  

Consideration for Change Controls  

While the change control process is highly prescribed, there is still room for a collaborative approach to accomplish change controls. Collaboration is important so that the Quality team can understand why a change control is being requested and how to best accomplish it. The need for change controls can also be subject to the interpretation of regulatory guidelines; one person may think an SOP meets regulatory requirements in its current form, while another person might think improvements are necessary. 

The most important thing to remember about the change control process is that it takes time. Often clients and GMP service providers will want to implement change quickly to avoid delays. However, to ensure the properly documented and effective implementation of change controls, budgeting the right amount of time for the process is key. The guidance of an experienced Quality team is invaluable in helping clients to understand the process and know what to expect.  

Contact us to learn more about how our team can support the manufacturing of your cell and gene therapy product.  

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