KEY SYSTEMS IN THE QMS
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):
- quality system
- facilities and equipment systems
- materials systems
- production systems
- packaging and labelling systems
- laboratory systems.
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.
WHAT A SIMPLE SYSTEM MEANS
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.
CONCLUSIONS
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, michael@pharmdservices.com
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