Change, rather than stability, engulfs us. In the wake of changing FDA enforcement practices, stricter post-Enron governance
regulations, increased threats from pharmaceutical counterfeits, and a precarious world situation, there are endless demands
for the reinvention and re-invigoration of business processes and the systems that support them. Maintaining a viable compliance
posture is even more critical to the success of biopharmaceutical quality assurance (QA) units. Our responsibility to customers
is enormous and our efforts worthwhile. We are legally and morally responsible for the safety and efficacy of products throughout
the supply chain, from development through manufacture to delivery to the consumer. This is not a simple task, especially
in an industry where the process is the product.
Table 1. Biopharmaceutical QA units have some level of influence over these five supply chain touchpoints.
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In the June 2002 issue of this magazine, the authors described their experiences in creating an effective biopharm QA unit
and the challenges they faced in the environment of two merging corporations.1 Those challenges included understaffed quality assurance and regulatory organizations, increasing regulatory scrutiny, a
complex and disparate supply chain, conflicting efforts between regulatory and quality needs, and advancing technologies that
increased the pressure on all parties involved. We focused on building a robust organizational structure that stressed individual
qualifications linked with strong communication tools.
Overall, we succeeded. We lifted a complex, multisite warning letter at an international manufacturing site,2 shepherded a successful multisite EMEA and FDA preapproval inspection,3,4 and saw the approval and launch of our first therapeutic protein to integrate proprietary antitampering and anticounterfeiting
technologies.5
The Ecosystem Paradigm The positive results experienced over the last year confirmed our design assumptions, strategy, and execution plans. However,
the real test of any organization is when it is stressed, when normal operating parameters are challenged. Just as chaos theory
posits that a butterfly flapping its wings in Brazil can cause tornadoes in Texas, small changes in an operating environment
can have an impact and implications far beyond the realm of a single decision maker.
In an ecosystem, complex and dynamic relationships create a synergistic, operational system. Similarly, the ecosystem of a
biopharmaceutical QA unit consists of many direct and indirect, dependent and interdependent relationships; change in one
area affects the others to some degree.
What Makes Quality in Biopharma Different?
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Our industry is inherently dynamic. Technology, regulatory, and business paradigms that worked yesterday may well be obsolete
today. Biopharmaceutical QA units, which are interwoven throughout the enterprise, must have the capacity to adapt to new
information and reallocate resources accordingly. The inter-relationships in an ecosystem, or touchpoints in the biopharmaceutical
model, produce varying results (Table 1). The quality of these results depends on the operating environmental conditions (that
is, stress), adequacy of design and philosophy, and effectiveness of leadership.
Stress There are many kinds of stress. We are all familiar with work overload, long hours, and new product launches. Assuming that
a robust organizational design and adequately trained and competent personnel exist, such factors should be manageable by
any QA unit. Catastrophic stress, however, can cause failure.
The Process Is the Product
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Changes, large or small, internal or external - such as interruptions to the commercial supply chain, negative regulatory
compliance action, and loss of customer satisfaction or business practice enhancements - amount to catastrophic stress when
there are no systems and processes to address them. Merger and acquisitions activity, inlicensing, outsourcing, and continuous
change in the supply chain (such as technology transfer issues and changes to the active pharmaceutical ingredient or at fill
and finish sites) are challenges to QA units. As technology and regulations continue to develop and evolve, regulatory posture
and company policies, procedures, and guidelines will change and impact the QA unit and the structure it supports. Personnel
and management changes (including responsibilities, philosophy, or skill sets) may appear subtle on the surface but have significant
impact on the organization.
External changes, outside the biopharmaceutical enterprise's control or influence, also present challenges for QA units. For
example, FDA is moving to incorporate the process analytical technology (PAT) initiative and quality systems inspection technique
(QSIT) into their processes, transfer responsibility for many products previously regulated by the Center for Biologics Evaluation
and Review to the Center for Drug Evaluation and Review, and address new concerns regarding counterfeiting, diversion, and
bioterrorism. FDA needs to move quickly, so it has increased hiring for enforcement staff, modified it's training programs,
and developed a risk-based approach to monitoring and enforcement. National expertise is being implemented for specified inspections,
and a higher level of expectations for compliance is in force. QA leadership will need to factor these variables into their
operating models.
