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J a n u a r y 2News
IPEC-Americas, Inc., 1655 North Fort Myer Drive, Suite 700, Arlington, VA 22209
www.ipecamericas.org, email: ipecamer@aol.com, Tel: 703-875-2127
Chair’s Note:
An Active Year for Excipients
Welcome to 2011 and what is sure to be
an active year for Excipients. The recent
enactment of the FDA Food Safety
Modernization Act gives us a glimpse into
what may lie ahead for Excipients. The
requirements surrounding third party
audits sets precedence for amending the
FD&C Act that may well carry over into
requirements for components used in
Chair’s Note: An Active Year for Excipients……...1-2
EXCIPACT Global Steering Team Holds Face to Face
Meeting in Cannes………………………………….……….2-3
Development of Guidance to Evaluate Particles
Present in Excipients is Next IPEC-Americas
Committee Project………………………………………….3-4
January Member Announcements and News
“Designing a Blueprint for Success” The 2011 CHPA
Regulatory and Scientific Conference………………..5
ExcipientFest 2011 Exhibitors’ Sold Out!...........5-6
IPEC-Americas 20th Anniversary Conference….....7
Upcoming PDA Workshop on Atypical Active
IPEC-Americas 2011 Web-Based Training………..10
IPEA Workshops……………………………………….…11-12
Important Industry Meetings ………………….…12-13
IPEC-Americas Committee Meetings……………....14
drug product manufacturing. Through
IPEC’s Legislative Initiative we provided
education and information to law makers
of reasonable audit programs based on our
and staff to help them create realistic
well established Excipient GMP guidelines.
legislation providing workable solutions
Now more than ever we need the Legislative
to ensure public safety. If the language in
Initiative to continue so that the IPEC
this law finds its way into a drug safety
position will be heard. Many thanks to our
bill, our efforts in establishing IPEA and
immediate Past Chair, Janeen Skutnik-
working with the ANSI NSF 363 and
Wilkinson, for championing this initiative
Excipact committees will provide our
and to all our member companies who are
member companies a compliance option
supporting this effort.
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IPEC-Americas News
As we look forward into 2011, our IPEC
The afternoon charges ahead examining
20 Year Anniversary Conference shines
excipient control in distribution services
brightly on the horizon of spring with a
with a powerful presentation by
great speaker line up capped off with the
Dwight Mutchler of Mutchler Inc. followed
IPEC Foundation Gala Dinner.
by insightful presentations on emerging
international issues in the excipient world.
This May 9th event at Baltimore’s Inner
This perfect day ends with the razzmatazz
Harbor inculcates IPEC’s collective
of our IPEC Foundation Gala Dinner
experience and knowledge into
featuring “The Capitol Steps” and
presentations that will enlighten
recognition of our past chairs. Bring some
participants, preparing a firm foundation
walking money because we’re running a
from which to implement “Total Excipient
50/50 raffle to raise money for the IPEC
Control”. Past Chair Dave Schoneker leads
Foundation Graduate Student Awards. I
our speakers list for a morning that
look forward to seeing participants from
brings together the concepts from IPEC’s
all of our member companies and
guidelines to form a system for “Total
encourage everyone to stay for
Excipient Control”. Following the coffee
ExcipientFest Americas on May 10th and
break we leap beyond the indubitable
11th. IPEC is please to again sponsor
safety arguments for excipient control
ExcipientFest as it travels this year from
into examining economic justifications
Puerto Rico to Baltimore’s Inner Harbor.
and ROIs for manufacturing investment.
The great presentations and exhibits
IPEC’s legal counsel from Buchanan
scheduled for this year’s ExcipientFest
Ingersoll and Rooney provides a historical
truly makes the science the fun.
perspective into Lawsuits and Liability.
EXCIPACT Global Steering Team Holds Face to Face Meeting in
The Excipact Global Steering Team
certification designed as an annex
consisting of member representatives
to the ISO 9001 Quality System. The IPEC
from the five founding organizations (IPEC
PQG Excipient GMP and the IPEC GDP
Europe, EFCG, PQG, IPEC-Americas, and
guidelines form the basis for this standard
FECC) met in Cannes to set Excipact
that will be equivalent to the ANSI NSF 363
milestones for 2011 and to refine the
GMP for Pharmaceutical Excipients
business and marketing plans. Excipact is
currently under development. The Global
a third party auditing program using a
Steering team serves as the final
standard for excipient GMP and GDP
approving body for the Excipact standard.
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IPEC-Americas News
The Excipact program allows excipient
project with the Global Steering Team
manufacturer and distributor companies
remaining intact and the project plan
to include GMP or GDP certification as
proceeding as currently written.
part of their ISO 9001 registration audits.
The basic business plan involves ISO
The Excipact working groups for GMP,
9001 third party auditing companies
GDP, and Auditor Competency also met
providing GMP or GDP certifications under
on the following day to incorporate the
license agreement with Excipact following
review comments of the standard manual
the guidelines and controls given in the
by the five member companies. The
Excipact standard manual. When a
Excipact plan is targeting a public
company successfully completes an
stakeholder review of the standard
Excipact audit as determined by a review
manual during the first part of this year
board within the third party auditing
and a launch of the Excipact certification
company, the Excipact organization
program by the end of 2011. To this end
issues a certificate and posts the
the Global Steering Committee divided
company’s name to the Excipact web site.
oversight responsibilities for the
To facilitate launch and shorten the time
line for realization of the Excipact
program, the Global Steering Team voted
to become a project team under the IPEC
individual project aspects to individual
team members and set a schedule of bimonthly review calls to ensure the project
legs move in tandem.
Federation until sufficient funding and
legal registrations as an independent
entity can be established. On the
following day the IPEC Federation board
voted to accept Excipact as a standing
Development of Guidance to Evaluate Particles Present in
Excipients is Next IPEC-Americas Committee Project
Following a recommendation by IPEC-
the detection and evaluation of particles
Americas member company Apotex Inc.
found to be present in excipients prior to
and review of research supplied by the
their use in a finished drug’s
company, IPEC-Americas members who
manufacturing process. This will be led by
participated in a January 18
Ms. Ruth Moses-Kogut, Manager, Supplier
teleconference agreed to form a working
Quality, AGO-QA, Apotex Inc.
group to develop industry guidance for
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IPEC-Americas News
The new project will be initially reviewed
Current practices employed by excipient
and evaluated in the February 23
makers and users on a global basis also
Excipient Composition Working Group
will be reviewed and evaluated, members
meeting. It is expected that one of the
who participated in the telecon report,
group’s first steps will be to review
thus it is hoped that additional IPEC-
current USP, FDA and other available
Americas full members and associate
international regulatory and
member distributors can be represented
pharmacopeial information pertaining to
at the February 23 Excipient Composition
particles’ presence in drugs and drug
Working Group meeting in Washington,
components, foods and cosmetics.
January Member Announcements and News Release
Generichem Corporation
Generichem announced January 13 that
Generichem’s major product lines include
Eric B. Oishi has been appointed its
pharmaceutical APIs, excipients and
President and Chief Operating Officer.
minerals. The company represents
Mr. Oishi joined Generichem in 2007 and
quality manufacturers from around the
has held management positions in sales,
globe including Katwijk Chemie, Tomita
operations, and new product
Pharmaceutical, Ferropharma, Nitika,
development. Prior to joining
Kelatron and many others. The company
Generichem, he was involved in sales
is headquartered in Totowa, New Jersey
and marketing at IBM and Boston
and has national distribution capabilities.
Scientific. Mr. Oishi succeeds Terrance
Connolly, one of Generichem’s two
founders, who has assumed the position
of Chairman. The other founder, Mrs.
Charlene Connolly, will remain Vice
President and Treasurer.
Founded in 1976, Generichem is a
leading supplier of raw materials to the
pharmaceutical, nutrition, food and
beverage and cosmetic industries.
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IPEC-Americas News
“Designing a Blueprint for Success” The 2011 CHPA Regulatory
and Scientific Conference
Registration is available for the 2011
Speakers from FDA’s Center for Biologics
CHPA Regulatory & Scientific Conference
Evaluation and Research and the Center
(RSC). This year’s meeting will be back at
for Devices and Radiological Health will
the Bethesda Hyatt Regency, Bethesda,
join Andy Fish, AdvaMed Diagnostics
Maryland, on May 5-6. Using a theme of
(and formerly of CHPA), to share
“Designing a Blueprint for Success,”
information about the intersection of
attendees will hear about current issues
medical devices and consumer self-care
and future trends affecting OTC
products. The CHPA website will be
products and dietary supplements. In
updated as program details become
addition to sessions addressing
regulatory and scientific topics, there will
be another devoted to exploring the
potential role of medical devices in the
self-care environment. Fred Degnan,
Esq. of King & Spaulding, will address
Don't miss the chance to hear about
trends and opportunities in consumer
healthcare. Online registration is
available now.
regulatory considerations associated
Register at: http://www.chpa-
with utilizing probiotics in OTCs and
dietary supplements.
ExcipientFest 2011 Exhibitors’ Sold Out
Thanks to all ExcipientFest Sponsors!
First ExcipientFest Americas in the U.S. is SOLD OUT!
Americas foremost Excipient conference and expo event, will take place during May 10th &
11th, 2011 in Baltimore, Maryland.
Over 40 of the most important companies in the Industry will be exhibiting and offering
their products and services at ExcipientFest Americas. Also, there will be more than 25
educational presentations, 4 workshops, and 2 Speakers' Round Tables featuring
professionals from different pharma areas.
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IPEC-Americas News
On May 9, IPEC-Americas one-day Regulatory Conference will precede
This affiliation brings added-value to Educational Program while increasing
attendee, exhibitor and FDA participation.
Celebrate IPEC’s 20th Anniversary
America’s Educational & Networking Marketplace
for Pharma Ingredients & Fine Chemicals.
IPEC-Americas News
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IPEC-Americas 20th Anniversary Conference
Registration for IPEC-Americas 20th Anniversary Conference is now open!
The theme for IPEC-Americas 20th Anniversary Conference is:
“Total Excipient Control (TEC); Tools for Managing Excipient Quality”
This year’s conference promises to offer a strong program for makers, users, and distributors of
pharmaceutical excipients. Educational sessions include the following topics:
Morning session:
• Introducing The TEC Concept
• What is TEC and why is it important?
• How does IPEC guidance fit into TEC?
• FDA Perspective on Excipients
• How much Does Your Excipient Really Cost”
• How TEC Reduces Financial Risk
• ROI – (return on investment) An Excipient Manufacturing Investment
Afternoon Session:
• Distribution Services – A Different kind of excipient control
• Contract Manufacturing
• IPEC Federation Update and Emerging International Issues
Evening Session:
• IPEC Foundation Gala Reception and Dinner (included in the conference fee)
• Recognizing IPEC’s Leadership
• Featuring the Capitol Steps!
Conference Fees:
• $640.00 IPEC-Americas Member company Employees
• $750.00 Non-member Employees
• $175 government/Academic
• $50.00 Student
• $150.00 – Gala Dinner ONLY
Sponsorships are still available for the Gala dinner; please contact Kim Beals at the IPEC office if
you are interested in sponsoring or co-sponsoring an event. kim.beals@ipecamericas.org
• Diamond - $7,000.00 – Table for eight, banners and signage - full page in program
• Ruby - $3,500.00 – Dinner for four, preferred seating, banners, signage and program
• Emerald - $1,500.00 – Dinner for two, preferred seating, signage, and program
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IPEC-Americas News
Upcoming PDA Workshop on Atypical Active Ingredients
Submitted by Bob Dana, PDA and Maria Guazzaroni Jacobs, Ph.D., Pfizer
(Members of the Program Planning Committee)
Sodium chloride, isopropyl alcohol and
compliance with Q7? We are not in that
glycerin – what do all these have in
business, but if asked to speculate, we
common? Not sure? Well, all three are
would guess not. What would happen if
commonly used as excipients and/or
they needed to comply with all the
adjuvants in drug products. But – as
criteria of ICH Q7 to continue to supply
they say in the TV commercials “Wait –
the pharmaceutical industry? Would
There’s More.” All may be active
their business model support the costs
ingredients in drug products. Normal
associated with the additional controls
saline, hand sanitizers and Glycerin
necessary to comply with all the Q7
Suppositories would all list these as
criteria? Again, we can only speculate,
active ingredients. They are not
but we would guess not. What then
typically considered to be such, but in
would happen to the drug products
some circumstances they may become
using these Atypical Active Ingredients?
Active Pharmaceutical Ingredients (APIs).
Continued speculation leads to the
So if they are not typically considered to
possibility that they might disappear
be APIs, what are they when used in
from the market.
products such as those mentioned
above? They are, in fact, Atypical Active
Recognizing this dilemma, PDA and the
Ingredients. Why is that important?
FDA have combined to develop a
Workshop on Atypical Actives. This
Well, as I’m sure we are all aware, the
Workshop, to be held in Bethesda, MD
manufacture of APIs is required to be
March 9 – 10, 2011 will explore the
done in compliance with Current Good
complex issues and questions
Manufacturing Practices. This means
surrounding the manufacture and use of
that, taken literally, these APIs must be
these compounds. The Workshop will
manufactured in compliance with the
feature plenary sessions on Day 1,
criteria in ICH Q7, the Good
allowing users of Atypical Actives and
Manufacturing Guide for Active
regulators to provide their perspectives.
Pharmaceutical Ingredients. How realistic
Legal aspects will also be covered in a
is that? Do the manufacturers of these
Day 1 plenary session, as will a
and other Atypical Active Ingredients,
discussion of some of the sourcing and
who prepare literally thousands of tons
marketing issues associated with these
or more of these chemicals, do so in
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IPEC-Americas News
Following a discussion of case studies on
desirable attributes of the Washington,
Day 2 presented by manufacturers,
DC area and most of all, the critical
users, and regulators, the Workshop will
importance of this topic make
split into breakout sessions where the
attendance an absolute must if you are
real work of the Workshop will take
involved in the manufacture, use or
place. Attendees will have the
regulation of Atypical Active Ingredients,
opportunity to discuss the technical
including those involved with
considerations and regulatory
purchasing, supply chain and contract
considerations associated with the
manufacturing operations, as well as
manufacture and use of Atypical Actives.
more traditional functions such as
The Workshop will be structured so
manufacturing, quality assurance, and
these breakouts are repeated a second
regulatory affairs. Visit the Workshop
time, thus allowing attendees to
participate in both.
www.pda.org/atypicalactives2011, for
The workshop will conclude with a
summary of the breakout sessions,
including major issues and
recommendations for a way forward to
resolve these issues. What better way to
participate in helping to shape the future
of the manufacture, use and regulatory
scheme for Atypical Actives than to
participate in this Workshop?
The Workshop will be held at the Hyatt
Regency Bethesda, conveniently located
at the Bethesda station on the
Washington, DC Metro, just 45 minutes
from Reagan National Airport, Dulles
International Airport, and
Baltimore/Washington International
Airport and only 30 minutes from
Amtrak’s Union Station. With any luck,
Washington, DC’s cherry trees will be in
blossom and, take it from those who
know, they are absolutely spectacular.
The convenience of the venue, the
more details about this Workshop,
including a detailed agenda and
information on how to register. On
behalf of the Program Planning
Committee, we look forward to seeing
you there.
IPEC Member Speakers include:
Janeen Skutnik-Wilkinson, Pfizer Inc.
(Workshop Chair)
David Schoneker, Colorcon
Rachael Roehrig, Ph.D.
Consumer Healthcare Products
Maria Guazzarini Jacobs, Ph.D. Pfizer Inc.
Iain Moore, Ph.D., Croda Europe
Alexa Smith, Colorcon
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IPEC-Americas News
IPEC-Americas 2011 Web-Based Training
Learn from the experts! Register now for
May 17: Stability –
the second series of educational webinars
Methods and rationale for determining
beginning February, 2011!!
excipient stability; IPEC’s common sense
scientific approach to stability studies for
Five educational modules covering a
excipients stored and transported via
variety of topics critical to manufacturers
uncontrolled conditions.
and users of pharmaceutical excipients
will feature industry professionals and
Presenter: Philip Merrell Ph.D., Technical
experts as presenters.
Marketing Manager, Jost Chemical
February 15: Significant Change How to understand and evaluate changes
June 21: Validation –
involving the manufacture of
Learn about IPEC’s needed validation
pharmaceutical excipients and when
guideline on manufacturing processes,
reporting is needed.
analytic methods and cleaning.
Presenter: Dave Schoneker, Director
Presenter: Ann Van Meter, Senior Quality
Global Regulatory Affairs, Colorcon
Systems Specialist, Dow Wolff Celluosics
March 15: Certificates of Analysis -
Pricing: Discounts offered for participation
Overview of IPEC’s revised guideline
in all five modules
based upon changing regulatory
$275.00 for members of IPEC-Americas
Member Companies - $500.00 for Non-
Presenter: John Giannone, Business
Development Manager, Cognis
Interested in one specific topic? Sign up for
one session!
April 12: Excipient Pedigree Why and how an understanding of the
$75 for IPEC-Americas Member Company
supply chain history of excipients is
Employees $150 for Non-members
critical to the safety of drug products.
Presenter: Linda Herzog, Marketing
Director, Asahi Kasei America
Best Value – Sign up for all five sessions
and save hundreds!
Register NOW at www.ipec-events.com
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IPEC-Americas News
IPEA Workshops
Excipient Auditing Workshop in
Arlington, VA (DC Metropolitan area)
April 5-7, 2011
There are only 10 spaces available! IPEA is
offering its three-day Excipient GMP
Auditing Workshop at its Arlington,
Virginia central office location. This
workshop offers participants training in
the assessment of excipient manufacturer
conformance to appropriate GMP
Workshop Leaders
Drs Art Falk and Irwin Silverstein
Defining Pertinent Audit Issues In
Writing & Rating Observations
Excipient Manufacture
Requirements vs. APIs
Hands-On Mock GMP Audit
Workshop Schedule:
Tuesday 4/5/2011 Registration first day
Tuesday-Thursday Workshop Sessions
Validation Workshop: taking place at
IPEA’s central office location in
Registration is currently open and
available on line, but hurry – this class is
already half full!
Arlington, VA on April 7-8, 2011.
This workshop consists of two half day
sessions and will take place at the close of
Register now by going to this link:
the Excipient Auditing Workshop, so
register for both classes!!
Validation is the key element in assuring
Course Overview:
Assessing GMPs for Excipient
that quality assurance goals are met and a
consistent excipient quality is regularly
achieved. The scope of this workshop
includes removing some of the
Where GMPs Begin
misunderstanding and preconceptions
Audit Planning
concerning validation.
Pre-audit Questionnaires
Alternative Audit Approaches
Audit Checklists & Techniques
Necessary Auditing Interpersonal
Workshop Leader
Sidney A. Goode, PharmD
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Course Outline:
Basic Explanation of Validation
Purpose and Gains of Validation
Compliance Requirements
Validation Planning and Resources
Issues to be addressed
Validation Master Plan
Validation Protocol preparation
Implementing protocol and
collection of data
Interpretation and analysis of the
Management of changes
Addressing re-validation
Writing the final report
IPEC-Americas News
1/2 day Workshop Session:
Thursday 4/7/11 1:00-4:30pm
1/2 day Workshop Session:
Friday 4/8/11 8:30am-12:00pm
Register now by going to this link:
For questions about either workshop:
please contact Valeria Stewart at IPEA, Inc.
at 703-351-5266 or email:
Workshop Schedule:
Thursday 4/7/2011
Registration from 12:00-1:00pm
Important Industry Meetings
February 7-10
SOCMA’s Informex
Charlotte Convention Center
Charlotte, North Carolina
Register: http://www.informex.com/socma
February 16-18
GPhA 2011 Annual Meeting
Hilton Orlando Bonnet Creek
Orlando, Florida
Register: http://www.gphaonline.org/events/upcoming
IPEC-Americas News
February 22-23
PQRI Workshop
Threshold and Best Practices for Parenteral and Ophthalmic Drug Products
Hyatt Regency Bethesda
Bethesda, Maryland
Register: http://www.pqri.org/workshops/index.asp
February 28 - March 2
Personal Care Products Council Annual Meeting
The Breakers
Palm Beach, Florida
Register: http://personalcarecouncil.org
March 9-10
PDA/FDA Atypical Actives Workshop
Coming Together to Develop Solutions
Hyatt Regency Bethesda, Bethesda, MD
Register: www.pda.org/atypicalactives2011
March 10-12
CHPA – Consumer Healthcare Products Association
Annual Executive Conference
The Fairmont Turnberry Isle Resort & Club
Aventura, Florida
Register: http://www.chpa-info.org/meetings/AECmtg.aspx
March 14-17
35th International FDA/University of Georgia College of Pharmacy
Good manufacturing Practices Conference: GMP’s – Spotlighting GMP Enforcement
The Georgia Center, The University of Georgia Conference Center and Hotel
Athens, Georgia
Register: http://www.GeorgiaCenter.uga.edu/conferences
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IPEC-Americas News
IPEC-Americas Committee Meetings - February
Tuesday, February 22
Executive Committee
12:00pm – 5:00pm
(by invitation only)
Wednesday, February 23
Quality by Design
8:15am – 12:00pm
Lunch – 12:00pm
Excipient Composition
1:00pm – 5:00pm
Validation Working Group
1:00pm – 5:00pm
Thursday, February 24
Good Manufacturing Practices
8:15am – 12:00pm
EIP Working Group
9:00am – 12:00pm
Lunch – 12:00pm
Excipient Qualification
1:00pm – 5:00pm
General Update
5:30pm – 8:00pm
Friday, February 25
Compendial Review
8:15am – 12:00pm
Lunch – 12:00pm
Regulatory Affairs
1:00pm – 5:00pm
NSF Excipients Standard
8:00am – 5:00pm