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IPEC-Americas News

z

IPEC-Americas, Inc., 1655 North Fort Myer Drive, Suite 700, Arlington, VA 22209

www.ipecamericas.org, email: ipecamer@aol.com, Tel: 703-875-2127

IPEC-AMERICAS NEWS

INSIDE THIS ISSUE

Chair’s Note ……………………………..…………………….1-2

IPEC-Americas Introduces the IPEC Insider……..2-3

IPEC Foundation Issues Awards at AAPS Meeting in October……………………………………………………….4-6 Notice of Executive Committee Elections in December…………………………………………………………..6 IPEC-Americas Committee Goals for 2011–Status

Report – Compendial Review/Harmonizaton,

Regulatory Affairs, and Safety…………………….....6-9

FDA News………………………………………………………9-10 EDQM News – October 2011……..……….…….…10-11 IPEC-Americas Webinar Training…………….……11-12 Important Industry Meetings …………………………..12

October 2011

Chair’s Note:

We are two months away from putting

2011 to bed and ringing in a new 2012.

As we approach the beginning of our

21st year IPEC-Americas will retire our

old monthly newsletter format for an

exciting insider update that combines

IPEC-Americas news with breaking

global excipient related news from

sources such as The Associated Press

and leading industry publications. We

partnered with MultiBriefs to provide

this news service to our members and

allow more opportunities for our

committees to share their work. Alan

Mercill and staff have provided us with

many years of monthly excipient insight

and IPEC-Americas highlights. Their

same enlightened articles will continue

in our new format but will now be

spread across the month so we no longer

have to endure the 30 day informational

famine or the nervous fidgeting commonly

associated with excipient information

withdrawal. In preparation for a brave new

year we will have a bold new newsletter and

we don’t have to wait until the holidays to

open it. Look for your personal copy in your

inbox sometime around the third week in

November.

The IPEC-Americas’ working groups

continue full force with our budget

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IPEC-Americas News

IPEC-Americas has partnered with

MultiBriefs to create a new bi-weekly

update, a free e-mail resource

providing comprehensive weekly news

briefings of the week’s top industry

stories.

Each edition of the IPEC Insider contains

articles gathered from an expansive list of

sources, including

The Associated Press, USA Today, and

leading industry publications.

IPEC-Americas Introduces the IPEC Insider

planning team completing the draft 2012

budget ahead of our December Executive

Committee meeting. Our membership

team met during the dog days of August

to review the contact leads collected in

between our ExcipientFest educational

conference and the summer trade shows

attended by staff. They developed a

banner follow up plan resulting in a very

successful fall with 2 prospective

member companies visiting the IPEC face

to face meetings in Washington, D.C. this

September and at least 4 other potential

new members for 2012 could be

possible.

The IPEC Foundation presented awards at

the AAPS annual meeting in Washington,

D.C. during the opening meeting on

Sunday, October 23rd. Dr. Steven Hoag

(University of Maryland School of

Pharmacy) received the Shangraw Award

and Dr. Stephen Edge (Novartis Pharma,

Basel Switzerland) received the Industry

Research Achievement in Excipient

Technology Award coupled with a

pleasant and very bright group of

Graduate Students.

Merging the IPEC Awards ceremony on the

Stage at AAPS in front of thousands of

pharmaceutical scientist and professionals

helped promote the IPEC name and mission

beyond what any other efforts could

achieve. At the awards dinner I talked with

Dr. Hoag, Dr. Edge and Dr. Karl Kolter (BASF

SE, last year’s Industry award winner) and

also heard great accolades to the IPEC

Foundation from the University of Maryland

School of Pharmacy Dean, Dr. Natalie

Eddington. As a reminder the IPEC

Foundation takes individual donations in any

amount and if your company has a

charitable fund, as many corporations do, a

donation to the IPEC Foundation is a good

investment in developing future talent in the

excipient field. On the evening before the

start of ExcipientFest 2012 there will be a

fundraising dinner for the IPEC Foundation;

so please plan to attend and support our

Foundation.

Look for the new IPEC-Americas news brief

in your in box and plan on attending our

face to face committee meetings in

Washington DC the week of December 5th.

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Home About Join Us Reference Center Member Resources Excipient Advocacy Contact Us

JRS Pharma

Pfizer

Lubrizol

New CDC Data Review prompts renewed call for PCV13 immunization

AAFP Share According to the CDC, more than 4,000 children are diagnosed with invasive pneumococcal disease, or IPD,

in the United States each year. IPD can manifest as bacteremia, pneumonia and even meningitis. A recent

CDC data review shows that children younger than 5 continue to develop IPD despite updated

pneumococcal vaccination recommendations, prompting the agency to renew its call for appropriate

immunization against Streptococcus pneumoniae infection. MORE

Signet, FMC and Roquette conduct technical seminars across the country

Express Pharma Share Signet, the Mumbai-based excipients specialist, together with its major partners FMC and Roquette,

organized technical seminars on various topics in Mumbai, Hyderabad, Bangalore, Ahmedabad and Delhi.

R&D, manufacturing and QA personnel from several pharma majors attended the workshops. MORE

Beginning Wednesday, Nov. 16, the

IPEC Insider will be delivered to the

inboxes of IPEC-Americas members,

keeping industry professionals

informed of trends and technology that

impact the pharmaceutical excipient

industry.

The IPEC Insider is a great way to keep

informed.

The electronic publication can be easily

read in your office, home, or via your

mobile phone or PDA.

Archived issues and an RSS feed will also

be made available.

To ensure proper delivery, be sure to add

ipec@multibriefs.com to your list of

accepted e-mail addresses.”

Frank Humada

Director of Publishing MultiBriefs Office: 469.420.2689 Fax 972.402.7035

See sample below of the IPEC Insider

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IPEC-Americas News

IPEC Foundation Issues Awards at AAPS Meeting in October

On Sunday, October 23rd, during the Annual Meeting of the American Association of

Pharmaceutical Scientists in Washington, DC, Dr. Stephen Hoag, Professor, School of Pharmacy,

The University of Maryland, received the $10,000 Ralph Shangraw Memorial Award for his work

related to research on the compression and capsule filling properties of excipients, controlled

release coating polymers, developing best practices for Quality by Design (QbD) and

the spectroscopic examination of excipient functional and excipient identification using NIR (near

infrared) spectroscopy.

Left to right - Robert Pinco, Dr. Stephen Hoag, Dale Carter, Dave Schoneker

Dr. Stephen Edge, Novartis Pharma AG, Basel, Switzerland, received the IPEC Foundation Award for

Industry Research and Achievements in Excipient Technology. Dr. Edge was recognized for his

many industrial and academic efforts related to excipient characterization, functionality and

quality, along with his work at Novartis in the area of inhalation excipients.

Dr. Stephen Edge and Dr. Philip Mayer (AAPS President)

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Five graduate students were also recognized during the dinner and AAPS formal awards ceremony:

Sunny Piyush Bhardwaj - University of Minnesota

“Effect of Preparation Method on Molecular Mobility in Amorphous Trehalose-Implications on

Physical Stability”

Justin R. Hughey - The University of Texas at Austin

“The Incorporation of Low-Substituted Hydroxypropyl Cellulose into Enteric Solid Solutions”

Sarah Pyszczynski - The University of Kentucky

“The Effects of Source Variability and Lot-to-Lot Variability on the Dehydration of Trehalose

Dihydrate”

Gaurav Tolia - University of Cincinnati

“Polymer elasticity and its relationship to diclofenac sodium release from oral controlled release

matrix tablets”

Julia Christina Kasper -Ludwig Maximilans University Munich

“Improving the quality and long-term stability of polymer-based non-viral gene-delivery systems –

A step closer form promising technology to application”

The graduate students were also recognized during the Excipient Focus Group session held on

Tuesday, October 25, where they received travel scholarships of $1,000 to attend the AAPS

meeting. The focus group is chaired by Wendy A. Dulin, Ph.D., of EPD Consulting. Assisting with

the event was R. Christian Moreton, Ph.D., Principal, FinnBrit Consulting, former Chair of IPEC-

Americas (2003– 2004).

A formal dinner to honor Dr. Hoag, along with Dr. Edge and the five graduate students took place

Sunday evening at the Old Ebbitt Grill, Washington DC’s oldest and most historic saloon.

Please help the IPEC Foundation shape the future by energizing research in excipients through

education and scholarship. To make a donation, please visit www.ipecfoundation.org.

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IPEC-Americas News

Is your corporation interested in other opportunities to support the Foundation? Please consider

sponsorship for the IPEC Foundation Gala Dinner to be held during the IPEC-Americas ExcipientFest

Conference in San Juan Puerto Rico April 24 – 25, 2012. Contact Kim Beals, IPEC-Americas Executive Director for additional information at kim.beals@ipecamericas.org

Notice of Executive Committee Elections in December

As set forth in IPEC-Americas bylaws,

the Executive Committee, whose

members are elected by the Board of

Trustees, is empowered to manage the

affairs of the Council and its members

and to direct the activities of standing

committees and working groups. The

Executive Committee is comprised of

thirteen members who are elected to

two (2) or three (3) year terms on a

rotating basis depending on their office.

Elections ordinarily take place during

the annual Board of Trustees meeting

each December, provided a quorum of

voting members is present.

The 2011 Trustees meeting and

elections are scheduled for Wednesday,

December 7, at the Buchanan Ingersoll

& Rooney law offices in Washington,

D.C. in conjunction with other IPEC-

Americas committee meetings. Four

offices are open for election.

A three year term for a new office,

e.g., Vice Chair for Maker &

Distributor Relations;

A new three-year term for the Vice

Chair for Membership; and

Two year terms for two separate

Elected Executive Committee

Member positions

Candidates will be announced in mid-

November. Only IPEC-Americas full

member company employees are eligible

to run for elective office. Persons willing

to do so are requested to forward their

names, contact information, a picture,

and a brief biography to the IPEC-

Americas office by November 15, 2011.

Following this a final slate of candidates

for the open offices will be forwarded to

you for review before the election.

IPEC-Americas Staff

IPEC-Americas Committee Goals – Status Report

COMPENDIAL REVIEW/HARMONIZATION

Achieve harmonization of excipient monographs and general chapters

published by USP/NF, EP and JP - harmonized ethylcellulose monograph

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issued, USP established expert panel on povidones – IPEC companies

represented on panel, provided input to PDG on propylene glycol assay

specs, providing support as needed for USP's monograph modernization

project; providing support for USP/FDA initiatives on EMA

Work with counterpart committees from regional IPEC Federation members

and IPEC-Pharmaceutical Discussion Group (PDG) in harmonization process –

joint effort on propylene glycol assay, cellulose derivative viscosity,

povidones, glycerin

Significant monographs & chapters for 2010 include: metal impurities,

sodium starch glycolate, titanium dioxide, residual solvents, viscosity of

cellulose derivatives, cellulose derivatives - elemental impurities

waiting for ICH input, residual solvents - EO to be removed from USP

<467> in 2012, viscosity of cellulose derivatives - no consensus from

working group on best approach to harmonization, workshop to be

planned for early 2012 to get more input from industry, TiO2 being moved

to bilateral harmonization; talc expert panel set up by USP, expert panel on

glycerin still being set up by USP

Work with USP & EP to implement bi-lateral harmonization on specific

monographs bilateral harmonization request sent to USP & EP, awaiting

decision (TiO2, MHEC, Type 12 CMC)

Continue to support addition of additives/processing aids in specific

monographs EC propyl gallate being added to monograph, other

additives/processing aids information being gathered for review with

FDA

Monitor nanotechnology developments with respect to impact on

monographs - monitor at each meeting, IPEC provided comments to FDA re:

proposed guideline

REGULATORY AFFAIRS

Created a global data base of acceptable international excipients with

applicable links and resources:

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IPEC-Americas News

A file containing weblinks to global databases of approved excipient and

drug products has been created and posted in the IPEC Members Lounge

under FORUMS. The file includes direct weblinks to information describing

each database as well as weblinks to the database interactive search engine.

Whereas the file contains about 14 different country listings for excipients,

more than 40 country listings are available for drug products. In addition, a

tab containing miscellaneous information pertaining to excipients (e.g. other

complimentary databases, resource book references and country specific

approval information) has been included.

NOTE: Information for this file was compiled by IPEC members for use by

IPEC members and is not intended to share/distribute to non-IPEC

members.

Developed examples of excipient DMF templates for China SFDA:

In July 2011 the IPEC Regulatory Affairs Committee helped to coordinate the

creation and submission of four different types of “sample DMFs” to IPEC

China to share with the China State Food and Drug Administration (SFDA) as

they develop their excipient DMF process/documentation requirements.

Exploring an understanding for timing and requirements for electronic DMF

filing:

In September 2011 Committee members began to learn more about current

PDUFA legislation that could impact the timing and requirements (eCTD) for

electronic DMF submission. The Committee will keep abreast of the

legislation and its potential impact, and will begin to develop a strategy for

how IPEC could proactively work with the FDA in the design and development

of appropriate systems (including future revision to IPEC-Americas Excipient

Master File Guide that issued in 2004).

SAFETY

Publish article from the Excipient Safety Symposium in the American College

of Toxicology Journal from annual meeting. Completed. A paper was

accepted for publication in the International Journal of Toxicology in 2012.

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Complete IPEC position paper supporting genotoxicity paper by Dr. Brusick.

Completed. A paper was sent to Dale and the IPEC Executive Committee for

review which will then be sent by Dale to the IPEC Federation. The paper will

be sent to the ICH EWG after review by the Federation.

Publicize the IPEC New Excipient Safety Evaluation Procedure at the

ExcipientFest Conference in Baltimore. Completed. The IPEC Procedure was

promoted at the IPEC exhibit and to the attendees. The Procedure was also

promoted at the CRS meeting in August.

Conduct Webinar IPEC New Excipient Safety Evaluation Procedure. A webinar

was not scheduled this year. Please check with Kim regarding the

scheduling of webinars.

Publicize and promote IPEC New Excipient Safety Evaluation Procedure; work with IPEC

member companies and committees to promote benefits of the Procedure for use by

IPEC members. The Procedure has been promoted this year. An article was published in

Tablets and Capsules. Also a presentation will be given at the Eastern Analytical

Symposium in November in New Jersey.

Obtain members for IPEC Safety Committee. We now have 6 members of the committee

with Brian Xu serving as co-chair.

Federal Register, October 25, 2011

http://www.gpo.gov/fdsys/pkg/FR-2011-10-25/pdf/2011-27529.pdf FDA Guidance for

Industry on What You Need to Know About Administrative Detention of Foods; Availability;

Notice

Comments can be submitted to FDA at any time.

FDA is announcing the availability of a guidance for industry entitled “What You Need to

Know About Administrative Detention of Foods.” This guidance provides information

pertaining to FDA’s authority to order the administrative detention of food for human or

animal consumption under the FD & C Act, as amended by the FDA FSMA.

FDA News

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IPEC-Americas News

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments

/FoodDefenseandEmergencyResponse/ucm276871.htm Guidance

http://www.ofr.gov/OFRUpload/OFRData/2011-27658_PI.pdf FDA Draft Documents to Support Submission of

an Electronic Common Technical Document; Availability; Notice; request for comments

FDA is announcing the availability of the following draft versions of documents that support

making regulatory submissions in electronic format using the electronic Common Technical

Document (eCTD) specifications entitled "The eCTD Backbone Files Specification for Module

1, version 2.0" (which includes the U.S. regional document type definition, version 3.0) and

"Comprehensive Table of Contents Headings and Hierarchy, version 2.0." Supporting

technical files are also being made available on the FD’s website. These draft documents

represent the agency’s major updates to Module 1 of the eCTD, which contains regional

information.

EDQM News

Following below are notices from the October report of the European Directorate for the

Quality of Medicines and Healthcare (EDQM, Council of Europe) believed to be of interest to

global IPEC members.

Certification

Monthly Report of Activities (September 2011): http://www.edqm.eu/en/News-and-General-

Information-164.html

New applications forms for new applications and revisions/renewals applicable from 1 September:

http://www.edqm.eu/en/News-and-General-Information-164.html

CEP suspensions and withdrawals have been updated.

More information: http://www.edqm.eu/en/News-and-General-Information-164.html

Publications

Pharmeuropa will be a 100% online format starting with Pharmeuropa 24.1. For now you can access the

new online version of Pharmeuropa.

More information: http://pharmeuropa.edqm.eu

The Standard Terms web page has been updated.

More information: http://www.edqm.eu/en/Standard-Terms-590.html

The following conference proceedings are now available to

download: International symposium on alternatives to animal testing, 8-9 September 2011

More information: http://www.edqm.eu/en/Proceedings-of-International-Conferences-83.html

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IPEC-Americas Webinar Training

The following technical guides are now available to download:

Technical Guide for the elaboration of monographs, 6th Edition 2011

More information: http://www.edqm.eu/en/Technical-Guides-589.html

Technical Guide for the elaboration and use of monographs on human plasma-derived products (2011)

More information: http://www.edqm.eu/en/Technical-Guides-589.html

Events

8 November 2011: Live Online Interactive Webinar on E-Submissions for CEP Applications.

Registration closes on Monday 31rst October at 4pm.

More information: http://www.edqm.eu/en/Webinar-E-Submissions-for-CEP-Applications-1453.html

Symposium on standardization & Control of Allergen, 24 November 2011, Strasbourg

http://www.edqm.eu/en/EDQM-Symposium-Standardisation-and-Control-of-Allergen-Preparations-

24-November-1454.html

CombiStats Training Session, 24-25 November 2011, Strasbourg

Registration is closed as the event is fully booked.

More information: http://www.edqm.eu/en/CombiStats-24-25-November-Strasbourg-France-

1236.html

CPhI, 30 November – 2 December 2011, Mumbai, India

More information: http://www.edqm.eu/en/Fairs-Exhibitions-254.html

5-6 December 2011: 7th Edition European Pharmacopoeia Training Session, Bratislava, Slovakia

More information: http://www.edqm.eu/en/PhEur-Training-Session-Bratislava-Slovakia-1395.html

22-23 March 2012: International Conference on the Certification Procedure, Larnaca, Cyprus

More information: http://www.edqm.eu/en/International-Conference-on-the-Certification-Procedure-

22-23-March-2012-Larcana-Cyprus-1451.html

Public Relations & Documentation Division

European Directorate for the Quality of

Medicines & HealthCare (EDQM, Council of Europe)

7, allée Kastner CS 30026

F-67081 Strasbourg (FRANCE)

Register Now! IPEC-Americas has 2 educational webinars remaining in the 2011 series! Even if you missed the first two on September 20

th (Quality Agreements) and October 25

th (Good

Manufacturing Practices), you can still register for all four. The link to the Quality Agreement and GMP recordings will be forwarded to you after you register.

Wednesday, November 9: Excipient Auditing

How IPEC Guidance Documents and the Excipient Information Package (EIP) Relate to the Supplier Audit Process

Presenter: Dale Carter, Global Quality Director, Silica, JM Huber, Engineered Materials

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IPEC-Americas News

Important Industry Meetings

Tuesday, December 20: 3rd Party GMP Certification

Preparation and maintenance - IPEA, EXCiPACT review

Presenters: Dale's Carter, Global Quality Director, Silica, JM Huber, Engineered Materials and Dr. Irwin B. Silverstein, Vice President and Chief Operating Officer, IPEA, and President of IBS Consulting in Quality LLC All webinars will take place from 11:00 AM – 1:00 PM Eastern Time and utilize the WebEx training platform. Registration Fees:

$275 IPEC-Americas Member Company Employees

$500 Non Members

One session price: $75 IPEC-Americas Member Company Employees $150 Non Members REGISTER: www.IPEC-Events.com

Information to join each webinar will be emailed a few days prior to each one with the call-in numbers.

November 14-16

ISPE Pharmaceutical Quality Systems (ICH Q10) Conference

Sheraton Hotel

Brussels, Belgium

Register: https://cvs.mci-group.com/cgi-

bin/regform.exe?company=6387&Event=EU11CEPQS&Language=1&Entry=9

November 14-17

2011 Eastern Analytical Symposium & Exposition

Garden State Exhibit Center

Somerset, New Jersey

Register: www.eas.org