Change Control in Pharmaceutical Industry

Change Control is an important process within a Pharmaceutical Quality System. It involves providing justification for changes. A Pharmaceutical Quality System should enable continual improvement and facilitate change. It should include arrangements for the prospective evaluation of planned changes and approval prior to implementation.

There should be checks that the quality objectives are achieved and that there is no unintended impact, particularly on product quality or patient safety. One change may have a domino effect and result in various other changes. Therefore careful consideration of associated changes is important.

The need for change may have many origins:

• Incidents
• Audit observations
• Ideas for improvements
• New or updated legislation or regulations

Change Request

Typically the Change Control process is started by making a Change Request. Change Requests should capture sufficient information to allow initial assessment of whether the change is required. Detailed plans or requirements are not required at this stage. This avoids wasted time developing detailed plans or specifications for things that are not required or will not get approval.

Change Requests provide an overview of the required change. They describe the issues which the change is intended to address, and how the change is expected to resolve these issues. And importantly, they include justification for why the change is required.

An initial review of the Change Request should either reject the request or approve that the request progresses to more detailed impact assessment.

Typically this involves identifying stakeholders and SMEs that will consider the types of change(s) that may be involved in making the required change. For example:

• Product
• Manufacturing Process
• Quality Control Process
• Facilities/Utilities/Equipment
• Computer System
• Regulatory/Quality Assurance
• Safety/Health/Environment

Read also: Types of Change Control in Pharmaceutical Industry

Rather than one complex impact assessment with separate questions about each change type, I recommend using a common framework which can be applied to the different types of changes.

For each type of change associated with the overall change, the SMEs will:

• Summarise what is being introduced or changed and justify why it is required
• Determine impact on product quality or patient safety (Direct or Not Direct)
• Determine what documentation needs to be updated

The impact assessments from each type of change associated with the Change Request can then be collated prior to a final review of the Change Request and impact assessment.

Approval of the Change Request and impact assessment at this stage allows change planning to continue for all the associated changes.

Read also: Frequently Asked Questions on Data Integrity

Change Control Flowchart for Pharmaceutical Industry

Resource Person: Kieran McKeever