22 BioPharm International eBook May 2021 www.biopharminternational.com
Ly n n ( R C A ): W h e w, a t o u g h
s u bj e c t w it h a to u g h a n s w e r for
some ma nu fac t u rers. T he reg u la-
tors were hit by this pandemic just
like the rest of us. They've had to
adapt to remote work a nd needed
to f igure out how best to discharge
their publ ic hea lth mission, whi le
c ont i nu i n g to prote c t t hei r mo s t
v a lu able re sou rce s —t hei r p e ople ,
just like we have done in the private
sector.
This took time and a great deal
of pr ior it i z at ion . T he r e g u l ator s
h a v e l i m i t e d r e s o u r c e s a l r e a d y
a nd w he n t he p a nd e m ic h it a nd
g r o u n d e d e v e r y b o d y, t h e y w e r e
forced to rethink what they did and
where they did it. The manufactur-
ers who produced products deemed
critica l to public hea lth were f irst
on the prioritization list. However,
these f irms weren't getting routine
sur veillance or pre-approval inspec-
tions. If/when they were inspected,
it was likely for a specif ic reason.
For the other manufacturers wait-
ing to get a new line, a new facility,
or a new drug product (or substance)
approved, they likely didn't receive
an inspection. T he r isk s were too
great. The same thing occurred on
t he submission /rev iew side of t he
spectr um. The rev iewers or asses-
s o r s — d e p e n d i n g o n w h e r e y o u
are in the world—also had limited
capac it y or t he y were not able to
get the answers from f irms because
the f irm's personnel likely were not
available. This unfortunately slowed
things down.
Adaptation to the new norm has
sped things up, but they 're not as
fast as they were in the pre-COV ID
w o r l d . U l t i m a t e l y, I t h i n k t h i s
pa ndemic has taught us in indus-
t r y a fe w d i f ferent lessons. F i rst,
it taught us the benef it of having a
robust qua lit y management system
a nd a wel l t hought out r isk ma n-
agement plan. Second, I believe it
taught us that patience is a virtue,
whether we liked it or not.
REFERENCE
1. J. Wechsler, "FDA Unveils
Extensive Manufac turing Violations
at Emergent," PharmTech.
com, April 21, 2021.
BP
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"If the contract
manufacturing
relationship isn't
collaborative,
there likely will be
problems."
—Steven Lynn,
Regulatory
Compliance
Associates
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