Perspectives on Pharma: Change Management in the Pharmaceutical Industry

Pharmaceutical companies have increased their emphasis on innovation and the introduction of new technology over the last decade or so. This has been initiated as a result of more progressive regulation and advances in manufacturing and control processes that enhance process and product understanding. The benefit is the supply of a more consistent quality product to the patient, and ultimately patient safety.

Innovation and the change management system

The pharmaceutical industry is highly regulated and requires companies to deploy and maintain a pharmaceutical quality system (PQS), to ensure drug products are manufactured to meet the desired quality and performance attributes. At the heart of an effective PQS, is the change control management system, a systematic approach to proposing, evaluating, approving, implementing, and reviewing changes (ICH Q10 Pharmaceutical Quality System guidance). Successful change management encourages everyone in an organization to adapt to and embrace a new way of working and is critical in driving continual improvement and innovation in products, processes, and systems.

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The role of quality culture

The best companies recognize that quality is not just about having an effective PQS, it is also about instilling a quality culture that enacts the requirements of the system, whilst recognizing and identifying innovation and improvements. In this regard, the QC laboratory, which is at the end of the manufacturing process, takes on additional significance, as it is the final arbiter of product quality prior to certification for release. As a unit with finite resources and extensive responsibilities, the QC lab is in a key position to promote and adopt new technology and innovations that result in reductions in cycle time and improved customer service.

The International Society for Pharmaceutical Engineering (ISPE)Cultural Report describes a road map to achieving a quality culture by considering six dimensions:

This pan-industry report, which is supported by major regulators, provides a set of tools and techniques to assess and improve the quality culture, and is now being widely adopted across the pharmaceutical industry.

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Pre-requisites for change

Any proposal for change requires evaluation of the change against the marketing authorization (MA) for the product, Good Manufacturing Practice (GMP) guidelines, and patient safety. Regulatory guidelines are intended to ensure controlled management of change and support continual improvement.

The MA, which is derived from knowledge acquired during product development, describes the manufacturing and testing requirements of the product in some detail. It is the contract between the regulatory authorities and the company that is applying to sell the product. The MA may include specific details of hardware that is utilized by a company for testing and manufacturing procedures.

Depending on the type of change proposed, there are a series of graduated regulatory authority responses, which range from simple notification to prior approval.  Examples of changes that require prior approval include alterations to test procedures for active pharmaceutical substances or variations to approved real-time release schemes. For example, a minor change, that requires only notification, would be a small change to an approved test procedure, or the deletion of a test procedure if an alternative test is already authorized.

Collaboration with hardware and software vendors continues to be an important aspect of the management of change. Any product improvements or updates to hardware and software must be documented, tested, and validated in accordance with GMP requirements. This is an area where organizations can work closely with vendors by delineating responsibilities for each stage of the validation cycle, notably during the definition of the user requirements specification, functional specification, design qualification, and factory acceptance testing. It may also be feasible for vendors to conduct some traditional on-site validation testing (e.g., installation and operational qualification).

Most importantly, consideration must be given to the impact of the change on the well-being of the patient. This is the primary concern when managing change. Changes should drive risk reduction and reduced process variability through continual improvement and innovation, ultimately maintaining or leading to improved patient safety.  

Strategic management of change

Organizations that want to improve and innovate manufacturing and testing procedures must carefully consider the impact, plan, and associated resources to deliver a proposed change. This is compounded by the sheer number of changes that a typical organization would like to implement and hence requires a risk-based method of prioritization.

Considering individual changes as part of an overall quality improvement and innovation strategy will help to ensure that beneficial changes are supported at the higher levels of the organization and are driven to completion. Without effective strategic management, individual changes tend to languish in the system and are often not realized. Organizations that consider change as part of the quality improvement and innovation strategy, tend to make the optimum use of resources to implement the changes and to improve. This is consistent with the “Leadership and Vision” and “Management Oversight and Review” dimensions of quality culture detailed above.

Change management and the regulatory authorities

The change management system is often a focus of regulatory inspections, and consistently appears in the top five of critical and major observations made by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and is frequently cited on warning letters issued by the US Food and Drug Administration (FDA). The consequences of non-compliance may have significant financial and reputational consequences for organizations that require remediation to achieve the regulatory requirements, regardless of the agency concerned.

Conclusion

In the pharmaceutical industry, change management is an integral element of the PQS, ensuring that innovations and improvements are managed and implemented effectively and with the intended outcome. The number and complexity of changes ongoing at any time within pharmaceutical organizations is staggering, and a high level of strategic and risk management is required to execute improvements to products, processes, and systems. Despite the complexity, continual improvement programs and proactive problem-solving initiatives are transforming the industry, with knock-on effects on employee engagement and overall business performance.  

To learn more about the key features of change management in regulatory labs, view the roundtable discussion, Perspectives on Pharma Roundtable: Key Features of Change Management in the Pharmaceutical Industry

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Additional Resources:

Blog: Perspectives in Pharma: Identifying and Minimizing Human Errors in Quality Control Laboratories

Blog: Perspectives in Pharma: The Role of Smart Tech in Regulated Laboratories

Whitepaper: The Role of Change Management in Supporting Innovation in the Pharmaceutical Industry