Quality Management Systems for Small Biopharmaceutical Organizations

What small biotechs need to know about quality management systems.
Sep 01, 2010
Volume 23, Issue 9

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).

Michael Gamlen
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 activities and 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.

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