APR Nov/Dec 2022 - 12

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Regulations Can Only Do So Much
The European Union has attempted to address the variability we
see in the interpretation of quality compliance regulations with a
legally mandated requirement for a " Qualified Person (QP) " who
meet specific educational and experience requirements as defined in
" Directive 2001/8/EC of the European parliament and of the council
of 6 November 2001 on the community code relating to medicinal
products for human use. "
This approach has its limitations in that it provides a legally required
retrospective review of product performance prior to release. In the
rapidly growing areas of advanced therapies and biopharmaceuticals,
the QP can prevent release of compromised materials but cannot
ensure consistent and sustainable performance. It requires a different
skill set to take the feedback from the QP and apply it prospectively as
a process improvement, risk reduction, or preemptive measure.
In the United States, the Code of Federal Regulations, Title 21, Parts
210 & 211, under part 211.25 requires " each person engaged in the
manufacture, processing, packing, or holding of a drug product
shall have education, training, and experience, or any combination
thereof, to enable that person to perform the assigned functions. " The
generalized nature of these requirements results in a dizzying array of
training seminars, webinars, meetings, and certifications which each
seek to provide guidance on interpretation of these regulations, there
exists no organized approach or requirement for ensuring consistency
from company to company or even site to site.
Without a solid educational foundation, the ability to consistently
interpret and apply the intent of regulations results in varying
approaches to good manufacturing practices.
This
approach to training and education is manifested in continued quality
deficiencies noted in regulatory inspections.
Can Pharmacy Schools Lead
Needed Change?
Currently, the focus of most Colleges of Pharmacy in the United
States remains preparing individuals to deliver clinical information
and therapeutics to patients, primarily in retail or hospital settings.
However, in a recent New York Times article by Noam Scheiber, " How
Pharmacy Work Stopped Being So Great, " the author points out
that cost pressures in the changing retail marketplace are driving
a reduction in the number of pharmacist positions, resulting in an
unhealthy working environment for many of those remaining.
As a graduate of a great pharmacy school program (Go UB Bulls!),
I believe the curriculum of these pharmacy programs was and
is an excellent foundation for creating strong pharmaceutical
manufacturing industry leaders. Courses in chemistry, microbiology,
pharmacology, pharmacokinetics, disease therapeutics, and pharmacy
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| November/December 2022
" fractured "
practice are an invaluable educational foundation for understanding
and applying the regulatory, technical, and personnel related elements
needed to develop and manufacture quality therapeutics utilizing
good manufacturing practices.
These colleges have worked successfully over the decades to
create robust, comprehensive curriculums which create capable
professionals in the retail/clinical environment. I believe the faculty of
these schools, with collaboration from regulatory compliance experts
from government and industry, can create an elective curriculum to
educate leaders in the many quality and regulatory facets of product
development and manufacturing.
Courses on data integrity, statistics, study design, regulatory filing
requirements, validation principles, key elements of good laboratory
and manufacturing practices, and essentials of aseptic operations
among others could form the core of this curriculum. These courses
could comprise an elective track for those who wish to maintain
the ability to practice as licensed pharmacists, as a post graduate
certification for those looking to expand their career opportunities, or
as an independent course of study leading to a unique degree.
Continuing education courses offered through these schools could
ensure currency in a rapidly changing environment. Ultimately, the
accreditation authorities for pharmacy education could establish
standards to bring national consistency to these efforts.
However, there is a need in the near term to address the currently
fractured landscape of training and education. A potential solution
is the creation of a consortium including regulators, industry experts
and educators to identify and codify the knowledge and behavioral
objectives for training and then serve as a review and certification
body to help attendees chose programs that deliver the needed
knowledge and skills. To supplement external education, the
identification of strong subject matter consultants to mentor key
leaders within the organization can be an additional solution to
strengthen internal capability.
Creating Industry Leadership for the
21st Century
The development of advanced therapies and rapidly changing
technologies for producing these treatments requires leaders in both
development and manufacturing to have the capability to interpret
and apply proper controls at all phases of the product lifecycle to
meet regulatory requirements. Effective and consistent application
of good laboratory, clinical, and manufacturing regulations, which
constitute the foundation for producing quality therapeutics, has
been an elusive goal in our industry for the last century. Together with
government and industry experts, educators in our nation's Colleges
of Pharmacy can provide an approach which can ultimately address
the quality leadership demands of pharmaceutical development and
manufacturing in the 21st century.
APR Nov/Dec 2022

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