Nanc
Published by the ISPE PNW Chapter
Serving Washington and Oregon
Editor: Katie Bohocky: aminc2@comcast.net
Ph 1.877.460.5880 Fax 1.253.265.3043
IN THIS ISSUE
President’s Message
PAGE 1
Upcoming Events
PAGE 1
Welcome New Members
PAGE 1
February Event Recap
PAGE 2
Feature Member Benefit
PAGE 2
Advertise with ISPE
PAGE 3
Communities of Practice
PAGE 3
2013 Classroom Training
PAGE 3
President’s Message
by Erik Westover
Following the success of our Georgetown Brewery Tour the PNW ISPE
Chapter has been busy planning events for the rest of the year. We are
working on two great events coming in April and May. We are focusing
the April event on a disposable technology lessons learned. We are still
compiling a group of speakers so keep an eye out for this event. We
look forward to talking with all of you about the latest technology. We
will have a variety of vendors, facility groups and users of this equipment
at the discussion and invite others to join in sharing your information.
We still have several openings for commuter conference topics in June
and in the Fall, please feel free to submit them to the Association Office
for review by the Board of Directors.
Finally, registration for the ISPE Golf Tournament is open! This will be
held on July 19 with a 2pm afternoon start. So get your 4-some
scheduled and click here to sign up to play today!
Save these upcoming event dates!
Thursday, April 25 - “Disposable Technologies - Lessons Learned”
Thursday, May 23 - "State of the Art Manufacturing Facilities and
Equipment"
News from International
PAGE 4
Welcome New Members!
_____________
Ron Castagno, BMWC Constructors, Inc.
Rick H. Ellison, BMTUS
Julia N. Hart, Cell Therapeutics, Inc.
Jared Roose, BMWC Constructors, Inc.
Cory W. Sauer, BMS
Submit Your
Articles!
Click here to submit
your articles for next
month’s Newsletter.
All suggestions will be
reviewed by the Board of
Directors.
MARCH 2013 NEWSLETTER

 198 active members as of March 4.
ISPE PNW – Serving the biopharmaceutical industy since the
mid-nineties.
ISP E P ACI FI C NO RTHW E ST CH AP TE R
NEW SL E TTE R March 2013
PAGE 1
February Georgetown Brewery Tour &
Tasting Recap
We hosted a great event in February, courtesy of
our friends at the Georgetown Brewery. Our
annual brewery tour was a huge hit, with many
eager beer connoisseurs in attendance. The
event included a ‘quiz’ at the end of the tour for
which winners were awarded great Georgetown
brewery clothing prizes. Thanks to all who
participated!
Thanks to our Sponsor!
Featured Member Benefit
Networking
with
professionals!
dedicated
like-minded
ISPE offers some of the best networking opportunities
you will find in the industry. Whether it's through our
extensive international network of Affiliate and
Chapters, our discipline-specific Communities of
Practice, volunteering on ISPE initiatives or at
dedicated networking events at ISPE conferences,
ISPE is your gateway to connecting with the top
technical minds in your region and all over the world.
Learn more
Join a Committee!
Your Board of Directors needs your help. Contact the
Association office at aminc2@comcast.net if you are
interested in joining a committee!
_______________________________
ISP E PA CIF IC NO RT HW E ST CHAP TE R
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Advertise with the ISPE PNW Chapter!
Newsletter Sponsorships!
ONLY $100 Per Quarter (3 newsletters
per quarter)
or $400 for an Entire Year (12 newsletters)!
It's a great, economical option for your advertising
dollar! Click here for more information!
Website Sponsorships
As a Website Sponsor, your firm's logo will randomly
rotate through six pages of the ISPE PNW Chapter
website for all of 2013!
Cost – ONLY $150 per Ad!
Upcoming Education Opportunites
Contact the Association Office
at aminc2@comcast.net or
Toll Free 1-877-460-5880 to secure your
Newsletter & Website sponsorship today!
ISPE’s Communities of Practice (COPs)
Connect with like-minded pharmaceutical industry
professionals through one of our 19 interactive online
communities offering exclusive global networking
opportunities and access to a community-specific
body of knowledge.
COPs are now only available to ISPE Members. Join
ISPE today to ask questions and share your expertise
in online discussions and access technical articles, ELetters and other valuable resources that will assist
you in increasing your effectiveness.
Click here to join a COP today!
ISP E PA CIF IC NO RT HW E ST CHAP TE R
NEW SLET TE R March 2013
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NEWS FROM ISPE INTERNATIONAL
ISPE Releases New Guidance for
Definition and Use of Non-Investigational
Medicinal Products in Clinical Trials
(TAMPA, FLORIDA, USA, 06 February 2013) – ISPE,
a leading authority on publishing best practices documents
for the pharmaceutical industry, announced today that it has
issued groundbreaking guidance to help companies
involved in clinical trials determine which medications
qualify as non-investigational medicinal products (or
NIMPs). The document also contains practical strategies for
risk management as it relates to classifying, sourcing and
packaging NIMPs.
“Until now, there has been no clear guidance to help define
NIMPs and their use. As a result, many pharmaceutical
companies take a cautious approach and treat all study
medications as investigational medicinal products. Since the
regulatory requirements for IMPs are so much more
stringent than for NIMPs, these companies are subjecting
themselves to unnecessary complications and expense,”
said Esther Sadler-Williams of Catalent Pharma Solutions,
one of the Guide’s lead authors. “This guidance answers
many of the questions surrounding what constitutes a NIMP
versus an IMP, and gives practical advice for simplifying the
use of NIMPs.”
The ISPE Good Practice Guide: Harmonizing the Definition
and Use of Non-Investigational Medicinal Products helps
companies who operate studies in multiple countries devise
strategies for risk-management that take into account
country-specific rules and regulatory requirements. It
clarifies issues related to NIMP supply chains and outlines
how the sourcing strategy employed for NIMPs can impact
a number of the manufacturing and clinical site aspects for
the complete clinical trial.
The ISPE Good Practice Guide: Harmonizing the Definition
and Use of Non-Investigational Medicinal Products is
available for purchase on the ISPE website.
2013 Facility of the Year Awards (FOYA)
Winners Announced
Sponsored by ISPE, INTERPHEX, and Pharmaceutical
Processing magazine, the Facility of the Year Awards
(FOYA) is an annual program recognizing state-of-the-art
pharmaceutical manufacturing projects that utilize new and
innovative technologies to enhance the delivery of a
superior project, as well as reduce the cost of producing
high-quality medicines. Now in its ninth year, the awards
program effectively demonstrates the accomplishments,
shared commitment, and dedication of individuals in
companies worldwide to innovate and advance
pharmaceutical manufacturing technology for the benefit of
all global consumers.
The winning companies and respective award categories
are:






Biogen Idec, winner of the Facility of the Year
Award for Facility Integration for its Flexible Volume
Manufacturing (FVM) Project in Research Triangle
Park, North Carolina USA.
F. Hoffmann – La Roche, winner of the Facility of
the Year Award for Project Execution for its TR&D –
Building 97 Facility in Basel Switzerland.
MedImmune, winner of the Facility of the Year
Award for Equipment Innovation for its UK
Automation Upgrade Project in Speke, Liverpool UK
Merck & Co., Inc., winner of the Facility of the Year
Award for Operational Excellence for its Vaccine
and Biologics Sterile Facility (VBSF) Project in
Carlow Ireland
Morphotek, Inc., winner of the Facility of the Year
Award for Sustainability for its Morphotek Pilot Plant
in Exton, Pennsylvania USA
Novartis Vaccines and Diagnostics, winner of the
Facility of the Year Award for Process Innovation
for its U.S. Flu Cell Culture Facility in Holly Springs,
North Carolina USA
The International Society for Pharmaceutical Engineering (ISPE) is an international society consisting of over 22,000
members in 90 countries. ISPE facilitates venues for networking, interaction, and information sharing within the region
and provides publications, conferences, and trainings on a wide variety of topics from Good Engineering Practices to
Quality Risk Management. Our membership constituency is made up of professionals from the biotechnology,
pharmaceutical and medical device manufacturers and other supporting industries such as academia, equipment
manufacturers, and construction/architecture.
ISP E PA CIF IC NO RT HW E ST CHAP TE R
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