Beyond Compliance:
How GMP Helps Organizations
Align, Assure, and Add Value
The traditional approach to GMP has been to take a compliance
perspective, and to do the least amount possible to keep FDA off your back.
Many companies scramble at the last minute when they expect an inspection to
"get their ducks in a row" to present the appearance of operating in a state of
control. FDA is the bad guy, and an adversarial relationship ensues.
GMP Mastery™ challenges participants to leave this perspective
behind, and use the regulations to harness the real power of GMP. GMP
provides the framework for making good business decisions that align with
your organization's values, objectives, and measures; assure
quality, productivity, health/safety, and regulatory compliance; and add
value to all stakeholders. As you pursue GMP Mastery™, the Mastery
Institute is prepared to be your guide along the path.
Alignment
Stakeholders approach life science companies from various
perspectives and value systems. Consumers want products that are safe,
pure, effective and affordable. Employees want the ability to earn an
income and contribute to the betterment of humanity. Stakeholders want a
reasonable return on their investment. FDA wants compliance with laws and
regulations. In order for trust to develop between these and other
stakeholders holding different perspectives, a common language and set of values
must be developed. GMP provides a framework for executives to take to all
stakeholders and discuss/develop values, objectives, and measures that all agree
upon. This dialogue with all stakeholders helps get everyone on the same
page, and reduces the likelihood that business integrity and ethics will be
breached.
Assurance
The four goals of GMP Mastery™ are:
-
Quality
-
Productivity
-
Employee Health/Safety
-
Regulatory Compliance
GMP Mastery™ goes beyond the sole focus on regulatory compliance
and expands to a more balanced approach to encompass the needs of all
stakeholders. This is not to say that GMP compliance can be ignored - on
the contrary. But it puts regulatory compliance within the context of learning
and meeting all stakeholder needs and expectations. Applying the right
dose of controls becomes an ongoing challenge and expectation. Becoming a
Masterful Doer requires assurance that your activities are balanced and
optimized.
Auditing is the tool to achieve
assurance. Auditing is not a game of "gotcha." It is a value added
activity whereby individuals and organizations take a look at what they are
doing and make sure that it corresponds to the goals of the organization (as
defined in the alignment stage.)
Added Value
Using the approach of going beyond compliance to Mastery makes
GMP a value-added activity. It is no longer a cost center, but a source of
efficiency and profit. Using GMP as a value-added activity opens the door
for all stakeholders to receive added value from their relationship with your
company. This is the real power of GMP Mastery™. Can you afford to
ignore it?
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