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T H E
P 1 P B L I N B
Operator Israel Gonzalez and production leader Betsy Galarza of the dry products plant in
Puerto Rico inspect a granulator used in the manufacture of validation lots for olanzapine.
Early validation
A key strategy recently introduced
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If anything,
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too long
A drug in demand
If anything, the market already has
been waiting too long for a drug like
olanzapine. A central-nervous-system
disorder whose causes are not completely
understood, schizophrenia afflicts more
than 5 million people worldwide. In the
United States, schizophrenia is the
number one mental illness in terms of
patients who are hospitalized. And
experts estimate that one-third of the
nation's homeless suffer from schizophre
nia. The disease severely impairs a
person's ability to reason and to feel
emotion, leading the individual down a
spiral of devastating despair.
"Schizophrenia is truly a malignant
disease whose signs and symptoms are far
from everyday human experience," said
Charles M. Beasley,Jr., M.D., a senior
clinical research physician.
Symptoms include hallucinations
and delusions, called positive symptoms,
as well as social withdrawal, apathy, and
an emotionless demeanor. Referred to as
negative symptoms, these latter manifesta
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LILLY
DEAR
group, and development projects management [in Indianapolis]. Once we drew the plan, we
stuck to our commitments. All of us were focused on the same specific goal and driven by the
same motivation. This is just a start in a series of speed-to-market projcts in which PRO1 is
currently participating and committed to continuously improve."
The eady site validation required the plant to implement a number of modifications to prepare
the site for full-scale manufacturing. The group responsible for the facility modification
worked extra hours during the winter holiday in order to have the plant ready by the
beginning of the year. Modifications were made to the granulation suite and the finishing
lines to meet the specific requirements for fulI.scale production of olnzapine in five different
tablet formulations.
Scale-up at the site began in August 1993, with manufacturing of the validation lots
beginning in March 1994. Among the specific goals of the first speed-to-market initiative for
the Puerto Rico plant site were a commitment to the project timetable, use of the 1996 u.s.
Food and Drug Administration standards for new product approval, quality and customer
satisfaction.
V
Even with a few Iurdles to clear Iong the path, the site met its stated goals and completed
the validation lots according to schedule.
To recognize this significant achievement and the roughly 60 employees who were a part of
the effort, the Puerto Rico site announced June 22 as Olanzapine Day and hosted a number
of activities to recnize the important contribution of the manufacturing site to the early
validation project
.
"This was just an utstanding effort between development and manufacturing to bring new
products on-line irjirecord time," said Beth S. Morris, manager of dveIopment projects
management
,.,
According to TereCok5n plant manager for the dry products plant in Carolina, this
achievement has st the standard for the Puerto Rico plant. "Wa ae foised on rufts and
doing it better evy time," she said. "Our utmost intrest is fo#stisfy the customer and
contribute to the mpany's speed-to-market goal."
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BARBA8 J RING
O2 MC909
28/2
MR17
Medca Mracles
Delivering on a Promise
People have urgent medical needs that continue
to go unmet. The rapid advance of science and
technology is breathtaking. Indeed, modern science
has become a manufacturer of miracles. However, the
unmet medical needs of people-life-threatening
diseases that medical science cannot successfully treat
or cure-present a sobering challenge. At Eli Lilly and
Company, our goal is to meet these needs.
Lilly research focuses on diseases that de' current
treatments. We're targeting the central nervous
system for diseases such as depression, Alzheimer's
disease, and schizophrenia. Endocrine diseases, such
as diabetes and osteoporosis. Infectious diseases.
Cancer, Cardiovascular diseases.
We're focusing on all the elements involved in
dealing with each of these categoiies. We want
people to achieve the best results in preventing and
managing disease. So we're innovating-in information
services, in educational programs, and in more
convenient ways for people to take medicines. Were
seeking breakthrough drugs using our expanding
knowledge and the most sophisticated technology in
the wod. We're accelerating the search for cures.
At LiIIy we're optimistic about the future.
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