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
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.
REASONS FOR THE LACK OF A GOOD QMS
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.
KEY STRATEGIC ELEMENTS OF AN EFFECTIVE QMS
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.