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Michael Gamlen is the managing director at Pharmaceutical Development Services, Ltd.
Graham Clapperton is the associate director of quality and compliance Pharmaceutical Development Services, Ltd., Nottingham, UK
What small biotechs need to know about quality management systems.
All companies in the biopharmaceutical and pharmaceutical sectors must comply with regulatory demands. When considering how to achieve regulatory compliance, even small companies, virtual or not, should consider implementing a quality management system (QMS).
There is, arguably, a common sense business rationale for companies to reach their compliance goals through the introduction of a well designed and easy to operate QMS. There are two business drivers that must be explored. The first is risk mitigation. The second is the need for small organizations to be as efficient as possible in today's challenging financial landscape.
A well designed QMS can, and should, be an integral part of a business's risk management policy. In both biopharmaceutical and pharmaceutical organizations, particularly those that outsource significant elements of their business, risk management is not an optional add-on, but is a key tool to ensure their growth during the early days of their organizations. Now, it is also an expectation of the regulators that organizations will quantify and manage risks in their supply chains. This is described in ICH Q9.
A well designed QMS will also ensure that correct alignment across the organization is achieved, so everyone truly understands and delivers what is expected of them. If those processes are well designed and linked through a compliant electronic QMS, small companies will be able to maximize the system's benefits. There is significant cost and risk to a company in this sector having an inefficient and ineffective QMS, and the absence of such a system will likely cause business failure.
At this point, it is useful to explore why the QMS has not been implemented by all small biopharmaceutical and pharmaceutical companies. There is no single reason, but rather a combination of causes that have caused this. Many organizations do not have a clear vision of how to develop and set up a QMS. In addition, because they typically are R&D-led organizations, they do not have the expertise to introduce a QMS.
These factors can cause organizations to make the wrong decisions in how they develop and introduce a QMS; then, when the QMS does not deliver the expectations of the business, the QMS is blamed in a self-fulfilling prophecy. If this is the case, the chances of convincing the management team to re-deploy a new QMS diminishes.
An effective and efficient QMS needs the backing of the organization's entire management team. Otherwise its introduction will not be aligned to the core aims of the business.
ICH Q10 describes the management team's responsibilities in the QMS. ICH Q10 has been globally accepted by regulatory agencies as the best top-level design for a QMS in the biopharmaceutical and pharmaceutical sectors. It clearly defines what is expected of the management team in a successful QMS. These requirements include:
Management commitment to ensure that the QMS is effective and achieves the quality objectives.
Definition of the quality policy to describe the quality strategy, including regulatory compliance.
Oversight of quality planning to define and communicate the quality objectives, ensure resources are in place, and establish and review performance indicators.
Resource management for all types of resources and their appropriate application.
Internal communication in a timely manner, appropriately done, and in the correct flow, including clearly defined escalation processes.
Management review of the QMS for suitability and effectiveness, and periodic reviews.
Management of outsourced activitiesand purchased materials as necessary.
If these elements are built into the QMS from the start, the strategies embodied in the QMS will be clearly aligned throughout the business. This allows the business to ensure that the main objectives of having a QMS—compliance, risk management, and productivity—are delivered by the organization through the application of the QMS.
The management team must consider how to embed the QMS in the organization and how the quality function can be organized and deployed to keep the QMS effective and compliant.
A review of various regulatory requirements can cause confusion regarding actual QMS requirements. These requirements are best defined in the FDA's quality system inspection technique (QSIT):
The elements required of these systems are described further in detail. The organization then can assess what elements are necessary for their business operations at their current stage of development. If an element is not necessary, a statement is made in the documentation of the QMS. This ensures that all necessary areas are considered as the organization develops and the QMS stays aligned to the business. The organization also must consider elements not described in the QSIT documentation such as EU-driven requirements for clear quality (technical) agreement between the company and its suppliers.
Selecting appropriate elements from a well-designed and compliant electronic system (e-system) is the most effective way to allow the QMS to develop as the business grows and its needs change. Ideally, an e-system would be populated with generic documents that could be individually tailored as required to meet the needs of the organization. Regular updates to the generic documents should be made annually to ensure continued compliance with changes in regulation and incorporation of best practices to the QMS.
At this point it makes sense to consider what a simple system really means. The documents in the QMS must effectively describe the key processes being used by the organization, but in a nonbureaucratic manner. The application of common sense goes a long way to ensure that documents and associated systems are well designed and effective in their application. The organization should develop a hierarchy of documents starting with policies at the top, which lead to the necessary procedures in the QMS.
There must be a solid and concerted disciplined approach to prevent the number of documents from increasing as the business develops. Adding documents will be necessary, but each one must be carefully considered to prevent the QMS from becoming unwieldy and disorganized.
Of course, a proactive training strategy is a key element of the application of a simple, well-designed QMS, and the development of the QMS must be done hand in hand with a well thought out training strategy. The organization also must consider whether there is a need for a cultural change as the QMS is deployed. The key to a successful QMS is the people who operate it—therefore, the culture, training, and organizational structure must embody the best approach to gaining staff engagement and alignment to the business strategy.
In both the biopharmaceutical and pharmaceutical sectors, a simple well-designed quality management system (QMS) can be a real business asset to an organization. It can ensure that the organization stays productive as it grows and develops. Effective application of a QMS will not only ensure compliance with regulations and ensure that the needs of the customers are met, but also will reduce risks and allow the organization to achieve and maintain a competitive level of productivity.
This can most effectively be done through a compliant e-system that contains well-written documents that clearly describe the processes used in the organization. A strong training strategy must accompany the introduction of the QMS, and the organization also must consider if there are any cultural or organizational elements that must be built into the implementation strategy for the QMS. This can be facilitated by a well-designed QMS that ensures correct alignment and engagement of the whole organization.
Graham Clapperton is the associate director of quality and compliance and Michael Gamlen is the managing director, both at Pharmaceutical Development Services, Ltd., Nottingham, UK, +44.115.9124277, email@example.com