- Vision—the
aspirational view of the future, and how Quality Management is integral
to the business strategy for operational performance and continuous
product availability to patients;
- Leadership—the top
business unit and functional heads who motivate, align, plan, and engage
the organization toward its quality goals;
- Standards—endorse
the policies and norms, which establish the quality requirements—the
interpretation of laws and regulations to your operation—the “what” is
required;
- Oversight—the
communication channels and forums that give Leadership visibility to product quality and
compliance risks and trends—in
order to make effective data-driven decisions—and provide Leadership the
means to exercise management responsibility.
- Management System—the totality of
policies, standards, processes that directs and controls activities with
regard to quality;
- Processes—to
ensure consistency and intentional ways of working when applying the
standards to your operation—and to control variables, including the human
variable;
- State of Control—quality
is about controlling variation, and the Pharmaceutical Quality System provide
the capability of self-detecting and self-correcting problems and give us
a clear picture of our current state of control.
- Continuous
Improvement—knowing the top regulatory compliance risks at any
give time and having project teams directed toward resolving them with
verifiably effective solutions.
- Execution—they manage the daily operation
of the quality processes described in procedures and ensure procedures
are effective;
- Maintenance—they ensure that the quality
process remains current with regulatory requirements and industry
practices; and remain applicable to your changing business;
- Performance—they measure how well the process
is working and identify problems with the process, and problems that the
process detects—and always seeking ways to meet the requirements in the
most efficient way.
- Escalation—they identify unacceptable
conditions or events that puts the patient and the business at risk—and take
the immediate actions necessary to mitigate the risk, and make recommendations
for permanently solving the problem.
To be clear—quality is everyone’s responsibility. Much like Safety is everyone’s
responsibility, it is the Quality function’s responsibility to establish
the ways and means for the Quality Management Triad; and ensure
effectiveness.
Why is The Quality Management Triad important?
The pharmaceutical industry is a dynamic business environment. Acquisitions, operational realignment,
portfolio changes, manufacturing relocation, facility re-purposing, and
organization restructuring and integration are among the strategies to increase
stockholder value. These continual changes impact the Quality Management System,
and like any other aspect of the operation, it must be managed to remain
effective and relevant.
Take this
hypothetical example:
A single-ingredient, solid-oral tablet manufacturer that constructed a dedicated facility for their new product.
A single-ingredient, solid-oral tablet manufacturer that constructed a dedicated facility for their new product.
Later,
high-potency, multi-ingredient tablets were introduced into this facility as
line extensions. The facility was then expanded to manufacture oral liquids and
eventually retrofitted to produce oral suspension products.
Plans were
being made to introduce parenteral drugs into the facility when the decision
was made to enter into an agreement with a contract manufacturing operation—a CMO—for
that technology, which was the firm’s first venture into a third-party
partnership.
All the while,
volumes were increasing, markets became global and the company turned to a
twenty-four seven operation to keep up with demand. The increased profitability
was directed toward the development of promising new drugs, while operating
expenses were reduced and tightly controlled to fund new initiatives.
While this was great news for investors and employees, an unintended consequence was quietly
undermining the business. The Pharmaceutical Management System had not evolved
with the business, and was no longer capable of reliably detecting and managing
product quality and compliance risks.
“Loss of
management control” was the underlying theme of the series of FDA483s and the
eventual warning letter when the site was fraught with recurring manufacturing
deviations, missed target dates, and ineffective solutions promised to the
Agency.
Although this
is a hypothetical case, many people identify with some parts of this story when
I share it.
Unfortunately,
the Quality Management System is often viewed as a resilient tome of instructional
content with little susceptibility to changes in the business environment.
Nothing could be farther from reality.
Quality
professionals across the industry who have looked back at their past quality
problems and regulatory enforcement action, say—ironically—that their Quality
Management System was a victim of their success.
Whatever the
environment, the Quality Management System must be managed to ensure that it is
Fit-for-Purpose and that it continually serves and protects the business.
The Quality
Management Triad is a key element of a business strategy to sustain performance and ensure a
continuous supply of quality product to patients.
The QA Pharm
