Introduction
Compliance
to current good manufacturing practice (cGMP) regulations is, in fact, a part
of normal pharmaceutical business that requires diligent management oversight.
Just as it is with other business functions, management has the responsibility to
ensure that systems are in place to effectively monitor the state of control in
order to intervene with timely decisions to manage risk, achieve goals, and add
stockholder value.
However, the
number of pharmaceutical companies that have received FDA warning letters or that
are under consent decrees indicates that management oversight of cGMP compliance
is a significant and continuing problem in the industry. There have been tarnished
reputations, loss of brand loyalty, stockholder lawsuits, and unprecedented
financial impact. At some point, the warning signals were undetected, unheeded,
or rationalized away.
This is the first in a five part series that explores the issues that can affect the ability of management to detect the
warning signals of significant cGMP compliance problems and offers suggestions
on how to gain control over this essential part of the business.
Obstacle 1: There is a Perceived Disconnect between cGMPs
and the Business
Not only is
there a perceived disconnect, but cGMPs are often viewed as an obstacle to
daily operations. There is no greater impediment to devoting personal attention
to any given matter than to question the value, or, at best, to think it a
burden for someone else to bear. When this is a dominant belief of those in
authority, it translates into speech and actions that are observed and emulated
by subordinates. Over time, this view is widely adopted and becomes part of the
company culture that influences the way daily work is performed.
Deep-seated
beliefs such as these are very difficult to change. Defending the business
value of cGMPs can only be successful if management actually believes it is true.
Unfortunately for many in leadership positions, this understanding is not part
of their education or experience. At best, their background may include a training
course or seminar, but their daily experience with the pharmaceutical quality
assurance and cGMP compliance functions are the frustrating hurdles to release
product to market.
The Opportunity?
To win the hearts and minds of management to embrace the business value of
cGMPs, one must put forward a rational argument that cGMPs are a business enabler and to integrate
this belief into the company’s formal value statement, new employee orientation,
and ongoing training. However, this requires a deeper understanding of the
foundation principles of cGMPs and recognition that they are no different than
those of the business.
The rational
argument goes like this:
- Patients take the individual dose, not the
average—sometimes every day for their entire life. Patients deserve the assurance
that their drug will meet every quality requirement for each dose, not
just on the average. That’s
the objective of cGMPs, and that should be no less the objective of one’s business.
- Manufacturing processes are
fraught with opportunities for unwanted variation to creep in from
incoming raw materials and components to equipment, test methods,
operators, facilities, utilities, and warehouses. Manufacturing a product
that is continually faithful to what market approval was based on and all quality
requirements only happens when done so intentionally. One can’t test
quality into products.
- Standard operating procedures
declare how a company intends to control variation and ensure
predictability. The
operative word is “standardize.” A company
has the liberty to standardize how it works to be as efficient as possible
to meet regulatory requirements. Contrary to common belief, cGMPs do not
prescribe exactly how to comply, but the expectation is to keep up with
current industry practice. A company is responsible for applying product
and technical knowledge to the practice of cGMPs.
- When following standard
operating procedures, records are created that document how the work was
performed and the results. The way and when information is
recorded and is important. Sometimes it is so crucial to the
outcome that recording information must be witnessed. Documentation is how
one proves and defends one’s work.
- Records contain data that describe
how well the intent was achieved. The data can be collected, translated
into performance metrics, interpreted by process owners and subject-matter
experts for analysis and decisions to target actions to continuously
improve processes, reduce waste, increase efficiency, prevent future
failure, and enhance knowledge.
- A regular
review of these performance metrics by a cross-functional management team
is part of the mechanism to provide oversight and governance. When taking action
on unacceptable trends a company becomes an anticipating organization,
rather than a reactive one. A management review of the quality
management system (QMS), like any other business review, is the primary
source of data-driven confidence that one is operating in a state of
control and is the basis for the confidence that one is maintaining an
economical control of quality, increasing operational capability, and the ability
to compete while meeting cGMP compliance expectations.
- Compliance
to cGMPs supports the business by ensuring continuous quality and
continuous supply of products to customers and patients. Continuous
quality is quality that can be trusted. Continuous quality enables
business performance to be predictable.
Although
the argument may be logical, often those who are in the best position to make the
argument, the quality function, referred to in cGMPs as the quality control
unit (QCU), may not be up to par. Part 2 will deal with the QCU.
The QA Pharm
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