Deviation and Change Control in Pharmaceutical Manufacturing

In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.

What Is the Difference Between Change Control and Deviation?

In the pharmaceutical industry, change control and deviation both describe a move from a validated state to a new state. However, change typically refers to an intended move to a new validated state, whereas deviation is an unintended change from the validated state. In this environment, change control describes the process of managing how changes are introduced into a controlled system.

Deviation Management in the Pharmaceutical Industry

Because the change caused by a deviation is by nature unintended, and because a deviation often goes undetected initially, it has the potential to affect multiple batches of product. Managing an unplanned change, or deviation, tends to be more complex than managing a planned change.

Key steps of the deviation management process are:

• Investigate the deviation’s potential effect on the batch it was found in and on other batches possibly affected.
• Manage immediate consequences by control or mitigation of the issue, with change control as appropriate.
• Identify the root cause, which may prompt additional corrective action and informs preventive action.

Deviation management software can automate and streamline the documentation, investigation and resolution of different types of deviations from written procedures and specifications, such as out of specification (OOS) deviations. An automated system enables companies to resolve deviations efficiently and use collected data as a basis for continuous quality improvement.

Change Control Process in the Pharmaceutical Industry

The term change control is used to describe the controlled set of actions necessary to ensure a change does not negatively impact a product’s safety, efficacy, quality or compliance. The control may be proactive, as with planned change. Or it may be reactive, as a response to mitigate or eliminate the consequences of unplanned change, also known as deviation.

Key features of change control include:

• A formal plan that identifies actions, inputs, outputs and control limits, which would define successful achievement of the desired change.
• A record of successful completion and review of the plan’s required elements together with supporting data.
• Obtainment of necessary regulatory approvals for the changed state before the product made under the change is released to market.
• Implementation of any new or updated Good Manufacturing Practice (GMP) documentation and appropriate staff training.

An automated change control system can integrate and streamline the entire change control process, from submission through resolution. A robust change control solution can connect users and data via a centralized system and connect the change control process with other quality processes to promote continuous improvement.

Elements of Corrective and Preventive Action (CAPA)

CAPA is a key component in the GMP expectation for deviation management, focusing on the investigation, understanding and correction of discrepancies while attempting to prevent their recurrence.

The corrective action elements of the CAPA are actions (and the records of these actions) taken to manage the immediate consequences of the detected deviation. These include:

• Assess and implement actions to restore the process to a state of control.
• Provide additional monitoring until full preventive action can be implemented.
• Assess whether the deviation may have gone undetected in other product batches.
• Assess the deviation’s implications for closely related processes/products, and initiate action where appropriate.

A documented root cause analysis is needed for successful preventive action, as failure to identify the true root cause will compromise the effectiveness of any CAPA. Establishing a root cause provides the logical basis to define the changes to process and/or controls necessary to prevent future deviations. The preventive action is the timely, recorded implementation of the changes identified by the root cause analysis.

An electronic CAPA system can improve CAPA efforts by automating all related tasks and ensuring repeatable processes are carried out according to a company’s procedures. CAPA automation can empower manufacturers to capture all relevant data, involve appropriate personnel, determine an issue’s status based on risk level and facilitate the development of a mitigation plan for the issue.

EQMS to Automate CAPA, Deviation and Change Control in Pharma

Deviation, CAPA and change control are interconnected processes, so an interconnected solution to handle them is the best approach. A comprehensive electronic quality management system (EQMS) will automate, fully integrate and streamline pharmaceutical manufacturers’ change, deviation and CAPA management – not to mention document control, training management, risk management and more – under a single platform. Using an end-to-end EQMS that automates and integrates these critical processes will help pharma companies reduce risk and ensure a consistent, efficient approach to the change control process in the pharmaceutical industry.