Published on Aug 15, 2025
Change is inevitable in any industry and is an essential part of development and growth. In the pharmaceutical industry, a good change control system is key to maintaining processes and procedures in a validated state. Effectively managing and controlling changes during pharmaceutical manufacturing and supply operations ensure consistency of product quality to the consumer and control of processes to the regulatory agencies. Any changes introduced, no matter how minor they are, may affect the quality of a product and therefore it is important to evaluate its potential impact and where necessary provide appropriate evaluation and actions.
The complexity and volume of changes in a pharmaceutical company is high, requiring a robust change control system to gain the purpose and objectives of improvements to products, processes, and systems. Changes can be planned anywhere in the pharmaceutical manufacturing and supply operations with an objective to improve the process, reduce costs, innovation or to comply to regulatory requirements. Some of the example areas where changes can be planned include equipment, facilities and infrastructure, manufacturing process, packaging material, raw materials, storage or transport conditions, suppliers, shelf life etc.
It is a GMP (good manufacturing practices) expectation that every pharmaceutical company has a standard procedure that describes how changes are initiated, authorised, executed, verified, monitored, and closed. Change management team in the manufacturing and supply operation often involves multiple stakeholders including sales and marketing, medical, legal, manufacturing, regulatory affairs, R&D, technical services, maintenance, and quality department of the organisation. The following are the major steps in managing a change.
Initiating change request: A change can be initiated and proposed by any employee or department of the organisation often in a standard format which provides the details of the proposal in a clear, accurate, and concise manner. The change request also includes description of the current state vs the proposed change, justification for the proposed change and an initial assessment of potential impact of the proposed change to products, materials, systems, regulatory filings, safety and environment.
Change impact assessment: In this step all the stakeholders and impacted business units review the proposed change and provide detailed assessment for potential impact and risks to the respective units and areas. The step also involves proposed actions to mitigate the impact and risks identified.
Change authorisation and implementation: After the apappropriate cross-functional evaluation of the change proposal, an authorisation to implement the change is provided based on the type and complexity of the change. All actions and tasks identified for implementing the change are executed in this step.
Change closure: A change is closed when it has been verified that all identified tasks have been completed. Any gaps between the authorised tasks and completed tasks are resolved and documented as a part of the change control record.
An efficient change control management system is important in the pharmaceutical industry to maintain consistency, quality, and compliance. There are several benefits of a robust change control process, some of them are as follows.
Product quality: Pharmaceutical products are manufactured through validated processes, using qualified equipment and distributed to patients under strict controls. Keeping control of changes allow the companies to ensure there is no negative impact of the changes to product quality and patient safety.
Regulatory compliance: Regulatory impact assessment before execution of changes allows companies to make timely revisions to regulatory filings and be compliant during audits and inspections.
Minimising risk: Applying risk assessment and ensuring the identified risks are mitigated through proper actions in the change management system help pharmaceutical companies to minimise any risks involved with the changes.
Continual improvement: Careful planning and management of changes help pharmaceutical to enhance process efficiency, reduce waste, and optimise operations while maintaining product quality.
Changes in the pharmaceutical manufacturing and supply operations must be controlled and managed through a formal change control system. The system should be part of the company’s quality management system and should be able to prevent adverse impact of changes to the product quality or patient life.
References:
ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Available at: https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf
Published on Aug 15, 2025 by Simóne Blair