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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

Excipient GMP Certification Standard……………..…..3

USP PNP Stakeholders to Meet May 19………..3&4

U.S.-China JCCT Task Forces Hold a 15th Year

Anniversary Meeting………………………………….……4&5

IPEC-Americas Committee News: Excipient

Qualification…………………………………………….……..5&6

Transition from Web Board to IPEC Forums Now

Complete…………………………………………..……….…..6&7

Last Call for Sponsorships……………………….……..….…7

Register NOW for IPEC-Americas 20th Anniversary

Conference…………………………………………………..……..8

IPEA Update…………………………………………………..……9

Update on NIPTE Excipient Database Project….9-11

20 IPEC-Americas Member Representatives to

Speak at 2011 PDA/FDA Pharmaceutical Supply

Chain Conference………………………………………….11-14

Supply Chain Security Also an Rx-360 Focus at

ExcipientFest!...................................................14-15

Important Industry Meetings ………………..…...16&17

IPEC-Americas May Committee Meetings………….18

Apr i l 2011

Chair’s Note:

We are now less than two weeks away

from our May 9th 20th Anniversary

Conference and May 10th + 11th

ExcipientFest. Representatives from our

member companies have been extremely

busy not only preparing for these events

but also preparing a response and FAQ

document to the fluttering of requests

and inquiries regarding exports from

Japan following the tragic earthquake and

tsunami. Our Vice Chair Industrial

Relations, Rick Green (CP Kelco), took the

lead in collecting comments and writing

the draft Response/FAQ document and

our 20th Anniversary Confernece program

has been modified to provide a session on

excipients and raw materials sourced

from Japan.

Meanwhile our Past Chair, Janeen Skutnik-

Wilkinson (Pfizer), in addition to

submitting an excellent presentation on

Atypical Actives for ExcipientFest also

provided the IPEC Executive Committee with

a synopsis of the Drug Safety Enhancement

Act recently introduced to congressional

committee by Dingell, Waxman, Pallone and

DeGette.

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IPEC-Americas News

Our legislative initiative team at Buchanan

Ingersoll is monitoring the progress of this

proposed legislation and an update will be

presented during our evening General

Update following the May 25th Excipient

Qualification committee. Live meeting

web access and the start time will be

provided prior to the meeting. Janeen,

Kim Beals (Executive Director IPEC

Americas) and Valeria Stewart (Executive

Assistant IPEC/IPEA) are attending an ASAE

conference in Washington DC this week to

learn how IPEC Americas can implement

programs to better serve our membership.

Our Vice Chair Science and Regulatory

Affairs, Dave Schoneker (Colorcon) has

submitted an exceptional keynote

presentation on “Total Excipient Control”

for our 20th Anniversary Conference and

followed with submitting an outstanding

presentation on “Elemental Impurities” for

ExcipientFest all while globetrotting across

China and India attending meetings and

representing IPEC-Americas. With China

being 12 hours time difference from the

US it was odd to get emails from Dave at 2

in the afternoon versus waking up to

emails sent at 2 in the morning.

Dave has also been active in spreading the

IPEC message throughout South America

and organizing a series of seminars in

Argentina and Brazil this past August.

Through the strong connections formed

by Dave we are pleased to have Jair

Calixto, Director of Sindusfarma, providing

an update on excipient activities in Brazil

at our 20th Anniversary Conference.

All in all it is a busy time for IPECers. I

mentioned just a few above but there are

many participants on conference calls each

week working on guidelines for Validation

(led by Ann Van Meter - Dow Wolff

Cellulosics) or Visible Particles (Led by

Ruth Ruth Moses-Kogut - Apotex Inc.) or

reviewing and updating our Regulatory

Links on the website (Coordinated by Amy

Vaughn – Colorcon) or developing the

educational program for IPEC-Americas’

ExcipientFest (Alexa Smith – Colorcon). All

this hard work truly deserves a celebration

and what better time to celebrate than at

the IPEC Foundation Gala Dinner featuring

the Capitol Steps on Monday night May

9th. I look forward to celebrating with our

great IPEC-Americas member company

representatives so if you have not made

your reservation it is not too late.

Page 3 IPEC-Americas News

When the ANSI NSF 363 – Good

Manufacturing Practices for

Pharmaceutical Excipients Standard is

published, excipient manufacturers will

have a national standard against which

they can become certified as having

implemented GMPs for the excipients they

manufacture. IPEC-Americas worked with

NSF to initiate the development of this

standard and the official notice (PINS

filing) was published on September 11,

2009 in ANSI Standards Action. The scope

was to document baseline GMPs criteria

for excipients necessary to demonstrate

adequate facilities and controls for

manufacturing and that excipients are

manufactured with consistent quality and

purity as declared by the manufacturer.

The standard includes all principles of the

IPEC PQG GMP Guideline for

Pharmaceutical Excipients. The

development committee consists of equal

membership from three categories:

Excipient Manufacturers; Excipient Users;

and Public Safety/Regulatory/Academics.

Excipient GMP Certification Standard

On May 19, at USP headquarters in

Rockville, Maryland, members of

organizations which comprise the USP

Prescription/Nonprescription Stakeholders

Forum, a group that includes PhRMA,

CHPA, GPhA, PDA, and IPEC-Americas will

The team includes employees from IPEC-

Americas member companies (Jeff

Brambora - Eli Lilly, Dale Carter - JM

Huber, David Klug - sanofi-aventis, Chris

Moreton - FinnBritt, Irwin Silverstein -

IPEA, Katherine Ulman - Dow Corning,

Ann Van Meter - Dow-Wolff Cellulosics,

Walter Joppy - J&J) and IPEC Europe

member companies (Iain Moore - Croda

and Steve Moss - GSK). This summer the

team will revise the completed first draft

of the standard in three meetings to

prepare for the September 2011

publication of the version for public

comment. Following the 45 day comment

period the team will prepare the final

version. The voting members of the team

will then ballot the final version for

adoption as an ANSI Standard with the

final standard expected to publish at the

end of 2011. Once NSF 363 becomes an

official ANSI standard, IPEA, the auditing

subsidiary of IPEC plans to adopt it as the

assessment criteria for their Excipient

GMP Certification program.

USP PNP Stakeholders to Meet May 19

be meeting to provide updates on current

projects, to receive stakeholder feedback

and to discuss matters for assignment to

new project teams. IPEC-Americas will be

officially represented by Past Chair David

Schoneker of Colorcon although several

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IPEC-Americas News

representatives of other IPEC-Americas

members also will be participating on

behalf of other member associations.

These are expected to include Immediate

Past Chair Janeen Skutnik-Wilkinson of

Pfizer, Scott Messner of Abbott, Neil

Schwarzwalder of Eli Lilly & Company,

Phyllis Walsh of Merck, and Dr. Rachael

Roehrig of CHPA, who will be chairing the

all-day forum meeting. FDA

representatives also will be participating.

Although not yet finalized, the PNP Forum

agenda is expected to include discussion

of

Issues related to USP-NF General

Chapter topics relating to <1>

Injections; elemental impurities;

standards for biologics, and

perhaps others;

U.S.-China JCCT Task Forces Hold a 15th Year Anniversary Meeting

On April 11 & 12 in Washington, D.C.,

U.S. and Chinese government officials

from the Department of Commerce, FDA

and the State food and Drug

Administration came together with U.S.

pharmaceutical industry association

delegates and observers to discuss and

try to resolve regulatory issues which

exist in the pharmaceutical and medical

device areas between their two countries.

David Schoneker of Colorcon was

Ongoing stakeholder interactions

and future directions of the

Stakeholder Forum and its project

teams;

USP updates on PF Online, the USP

Medicines Compendium, and their

Monograph Submission Portal.

Following the Forum a report will be

provided to affected IPEC-Americas

committees during the May 23-26

meetings in Washington, D.C.

IPEC-Americas representative as a

member of the Pharmaceutical Task

Force.

The Chinese delegation leader was

SFDA’s Department of Drug Registration

Director General, Zhang Wei. During the

meeting Zhang provided an update on

the status of various regulatory issues

regarding drug registration, GMP rules

and supplier controls.

Page 5 IPEC-Americas News

He also reported that a draft Drug Master

File (DMF) regulatory system for

excipients could be published later in

2011 and that industry comments would

be permitted before it is implemented.

An SFDA update on SFDA anti-

counterfeiting activity also was provided

during the program and cooperation with

the pharmaceutical industry on meeting

GMP standards remains a major initiative.

The Excipient Qualification Committee

was formed in 2004. According to the

IPEC-Americas by-laws, “The Excipient

Qualification Committee provides

guidance to excipient manufacturers on

the development of an excipient grade

material and its specifications; guidance

on how users select and assess excipients

for use in their formulations; and

guidance on elements included in the

necessary excipient maker-user

negotiating process leading to quality

requirement agreements between the

parties.”

Former Committee Chairs have been Dave

Schoneker, Colorcon (2004-6) and Maria

Guazzaroni Jacobs, Pfizer (2007–8).

David Klug, sanofi-aventis (2009–11) is

the current Chair.

Guidance documents developed and

IPEC-Americas Committee News: Excipient Qualification

Additional information on matters

discussed will be reported during IPEC-

Americas Committee meetings in May.

published by the Committee currently

include:

Qualification of Excipients

for Use in Pharmaceuticals,

2008

Excipient Information

Package (EIP): Template and

User Guide, 2006, rev. 2009

Excipient Pedigree – IPEC

Americas and

Europe position paper,

2009

Quality Agreement Guide

and Template, 2009

International Pharmaceutical

Excipients Council Glossary,

2010

In addition to developing these

publications, Committee members have

been diligent in promoting awareness

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IPEC-Americas News

and utilization of published guides

through various journal articles and

presentations. Committee members have

also lent ongoing support to the IPEC

Americas webinar initiative by creating

and presenting webinars on certificate of

analysis, significant change and excipient

pedigree.

For 2011, the committee plans to update:

the IPEC Excipient

Information Package:

Template and User Guide

the IPEC-Americas Significant

Change Guide and IPEC-

Americas CoA Guide for

consideration as IPEC

Federation guidance

Transition from Web Board to IPEC Forums Now Complete –

Notice to IPEC-Americas Members

To ensure that the revised Guide takes

into consideration your company's input,

please plan to participate in the 25 May

2011 committee meeting in Washington,

DC or via teleconference. The meeting

agenda will focus on finalization of

the CoA Guide with reports expected

from the excipient information package

working group as well as the

subcommittee supporting FDA’s effort to

develop comprehensive screening of

pharmaceutical excipients.

For more information in the future, log

onto IPEC-Americas website Forum

Section as explained in the next article.

We look forward to working with you!

This is to inform IPEC-Americas

members that the Web Board will no

longer be used to post committee

documents and information. The new

IPEC web site Forums will be utilized for

these purposes.

The Forums area of the web site was

established for discussion among

members about topics relevant to IPEC.

The Forums also serve as an archive of

discussions that over time will become a

valuable reference tool on a variety of

subjects.

Members are encouraged to take a

minute to familiarize themselves with the

layout of the Forums and then to

participate as often as they like, both

with their own original messages and

with replies to other members' postings.

All postings should be of material that is

relevant to IPEC.

The only requirement to using the

Forums on our web site is being logged

in as a member company employee.

People from non-member companies will

Page 7 IPEC-Americas News

Last Call for Sponsorships!

Following are opportunities for your company to support IPEC-Americas and to gain

recognition!

Gala Dinner Sponsorships:

Diamond - $7,000 – Preferred table for eight, banners and signature- full page in program

Sapphire - $5,000 – Sponsor the “Capitol Steps” – SOLD OUT, MUTCHLER INC.

Ruby - $3,500 – Dinner for four, preferred seating, banners, signage and program

recognition.

Conference sponsorships:

Breakfast:$1,000.00

Coffee breaks: $500.00 SOLD OUT! – BASF & DMV Fonterra Excipients

Luncheon: $1,500.00

Please contact Kim Beals for additional information! Kim.beals@ipecamericas.org

Media Sponsors and Partners:

Pharmaceutical Technology Magazine

Drug Development & Delivery Magazine

not be able to see this part of the web

site. Valeria Stewart will be your point of

contact for the posting of information or

documents on the IPEC Forums, so don’t

hesitate to contact her for assistance or

more information once you decide to

utilize this new tool.

Please be sure to read the important

guidelines before posting documents to

the Forums. Guidelines for posting

documents in Forums can be found at

http://ipecamericas.org/forum/how-

upload-files

For help with IPEC Forums please contact:

valeria.stewart@ipecamericas.org

703-351-5266

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IPEC-Americas News

Register Now for IPEC-Americas 20th Anniversary Conference

Registration is on-line for IPEC-Americas 20th Anniversary Conference at www.ipec-

events.com . For speaker updates and confirmations please visit the IPEC-Americas

website at www.ipecamericas.org and click on the 20th Anniversary logo!

If you are arriving early for ExcipientFest be sure to register for

IPEC-Americas Foundation Gala Dinner which will be held on Monday evening, May 9,

from 6:00–9:00 pm. Registration for the Gala Dinner is on-line and proceeds from the

dinner will directly benefit the IPEC Foundation, a 501(c)(3) non-profit charitable

organization. The evening’s entertainment will consist of “The Capitol Steps” Americas

Favorite Political Satire Group, sponsored by Mutchler, Inc.!! Register now!

Follow Us On……

Twitter

Facebook and

Linkedin at: http://www.linkedin.com/groups?mostPopular=&gid=1898210

Page 9 IPEC-Americas News

IPEA certified two Dow Chemical manufacturing sites for Propylene Glycol USP/EP. The

facilities in Freeport, TX and Plaquemine, LA were certified for Conformance to Excipient

GMP. Also certified was Dipropylene Glycol Low Odor.

IPEA also completed the reaudit of the Eastman Chemical Kingsport, TN facility for the

manufacture of 4 excipients; Cellulose Acetate Phthalate NF, Cellulose Acetate Butyrate NF,

Cellulose Acetate 320S and 398 NF/EP.

IPEA also conducted an excipient auditing workshop in Arlington that was sold-out and

has scheduled a Fall workshop for October 25-27 at the same venue. To register go to:

http://www.ipeainc.com/auditingworkshop11.htm

IPEA Update

Update on NIPTE Excipient Database Project

The National Institute of Pharmaceutical

Technology and Education (NIPTE) is a

consortium of eleven North American

universities whose graduate programs are

cooperating in promoting and conducting

pharmaceutical technology research and

education. A current project involves

creation of an excipient functionality and

functionality testing database from

information by excipient producers and

users for FDA, hosted on

www.pharmaHUB.org

It is open access (read-only), containing

data on commonly used excipients,

from literature and commissioned

academic research studies. An update

meeting was held on 31st March in the

Kurz Purdue Technology Center, West

Lafayette, IN and the following report is

provided by IPEC-Americas Quality by

Design Committee Chair Dr. Brian Carlin

of FMC Biopolymers.

The database is the first step in

developing an excipient information

management system that can be used to

guide formulation development. There is

some flexibility in how the data is

organized to provide a structure that can

grow into a full information management

system.

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IPEC-Americas News

To start the process it was decided to

focus on direct compression (DC)

excipients, and once the database

structure is defined other classes of

excipients will be added. Microcrystalline

cellulose (MCC) was chosen as the lead

excipient for further database

development, as it is the most commonly

used, high-volume, continuously

produced DC excipient.

The key features of the database include:

1. Traceability of information to a test

method, equipment and person or

organization that supplied the data. It

is hoped that the structured entry of

information into the database will help

to standardize test methods, which will

facilitate comparisons.

2. The database is structured around the

listing of compendial excipients,

products containing those excipients

and data on selected lots of excipients.

3. One has the ability to easily find key

characters or attributes of an excipient

and compare by excipient type,

different grades or products and

functional categories.

At the March 31, 2011

meeting/teleconference at Purdue, an

online demonstration highlighted the key

features of the database. Discussions

addressed features, ease of use,

incorporation of pre-existing

user/supplier databases, and possible

mechanism to fund the future

development of the database.

A key discussion point was that many

excipient-related effects on finished

product performance are a function of

the specific application (formula,

process, scale). In other words there may

be no general correlation between a

specific excipient attribute and finished

product performance. However in certain

circumstances the variability of the same

excipient attribute may be highly

significant to finished product

performance.

Data on excipient attributes combined

with finished product performance data

in the NIPTE database would enable

multivariate data mining to identify such

ephemeral interactions and guide

research into their mechanisms. It was

noted that PQRI is also looking at this

area and the NIPTE database could be

the ideal clearing house for such a data

meld. On the excipient side this would

require access to supplier data, which

may raise problems of confidentiality,

but the database can be configured in

such a way to allow the blinded

incorporation of such data, if eventually

made available.

For continuous-production high-volume

(e.g.MCC) a finer level of scrutiny is

required beyond Certificate of Analysis

Page 11 IPEC-Americas News

(CoA) data, which tends to average out

underlying variability. The traceability of a

particular excipient needs to link user

reference numbers, through supplier

“batch” numbers, to intra-“batch”

references. As MCC “batches” may

represent hundreds to thousands of

tones, over weeks to months of

continuous manufacture, access to the

most relevant in-process data will give a

more accurate assessment of the impact

of the excipient variability on finished

product performance. One way of doing

this is sequential numbering of containers

within a given “batch”.

There is sufficient flexibility in the

structure of the database to link to pre-

existing databases or simply import data

via spreadsheets.

The database initiative is currently funded

by FDA and in the future it is likely that

such monies will switch more to scientific

research on excipients, rather than

maintenance of the database itself. NIPTE

cannot solicit commercial funds directly

so one idea would be for NIPTE to partner

with IPEC on future database

development.

Prabir Basu of NIPTE proposed:

Further discussion* at the 24th

May IPEC QbD meeting in

Washington DC.

A subsequent meeting with FDA,

with representation from the IPEC

QbD Committee.

A two-day workshop on excipients

for 2012 in collaboration with

FDA/AAPS.

*Prior evaluation of the

live database online at

pharmaHUB.org is

recommended to

maximize committee

discussion time. If

enough people are

interested NIPTE would

be willing to host a

demonstration

interactive webinar

before the 24th May IPEC

QbD Committee meeting.

20 IPEC-Americas Member Representatives to Speak at 2011

PDA/FDA Pharmaceutical Supply Chain Conference

On occasion, according to politicians and other pundit types, there are situations

where “a title sometimes can say it all.”

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IPEC-Americas News

In addition to providing welcoming

remarks during the opening session,

both Mr. Berg and Dr. Wolfgang are

moderating separate sessions during the

conference.

Mr. Berg is leading an introductory

session on June 6 entitled Supply Chain

Security - A Global Initiative.

This will include presentations by FDA

and European government speakers and

another from Gerry Migliaccio, Senior

Vice President for Network Performance

in Pfizer’s Global Manufacturing

Division. He (Mr. Berg) aso is moderating

the closing session on June 7. This is

named The Threats are Real: We Must

Remain Steadfast in our Mission to

Protect Patients. In this session an FDA

speaker will provide a report on coming

regulation and regulator expectations

and Amgen Senior Vice President, Martin

Van Trieste, will close with a

presentation entitled Patients are

Counting on Us: We Must Succeed.

Dr. Wolfgang’s session will take place on

Monday afternoon, June 6 and will cover

Supply Chain Tracking: Materials. Here

speakers will provide examples of

supplier data management systems and

their value in maintaining supplier risk

profiles. Speaking will be Amy Mutere,

Associate Director, Supplier and

Distribution, Genentech Inc., Londa

Ritchey, Director, Supplier Quality, Pfizer

and Dwight Mutchler, Vice President,

Sales and Marketing, Mutchler Inc.

That really seems to be the case when

one examines the program set forth at

www.pda.org/suppychain2011 for the

upcoming 2011 PDA/FDA Pharmacuetical

Supply Chain Conference and TRI Course

in Bethesda, MD. Why? Because the

program brings together regulators and

pharmaceutical industry representatives

to share their views on what is being

done now to prevent pharmaceutical

counterfeiting, product diversion, and

economic adulteration to improve global

supply chain integrity and security.

And that is why 20 IPEC-Americas

member representatives from 10 different

IPEC member companies are participating

as speakers during the conference, along

with FDA, PhRMA members, a distributor

organization and Federal Express. Pfizer,

for example, is providing 6 speakers and

Amgen 4. Two other IPEC-Americas

member companies, e.g., Baxter

Healthcare and Genentech, each have two

speakers, and J.M. Huber Engineered

Materials, Doe & Ingalls of North Carolina,

Colorcon, Mutchler, Avantor Performance

Materials and IBS Consulting in Quality

one each.

Conference Planning Committee co-chairs

are IPEC-Americas Executive Committee

member Eric Berg, Amgen Director of

Supplier Quality, and Steven M. Wolfgang,

Ph.D. Dr. Wolfgang is Team Leader for the

Data Analysis Team within CDER’s

Division of Manufacturing & Product

Quality.

Page 13 IPEC-Americas News

IPEC-Americas Past Chair David

Schoneker, Colorcon’s Global Regulatory

Affairs Director, will discuss Excipient

Control – A Culmination of 20 Years of

IPEC Guidance. He will be followed by

Patrick Ford, Senior Director, Global

Security, for Pfizer. Mr. Ford will discuss

the ongoing global security approach

against counterfeiting and what it

currently includes.

The second day, Tuesday, June 7, is

named Pulling It All Together. The early

morning session begins the process

through a program entitled Creating the

End-to-End Approach moderated by

recently retired FDA official Edwin

Rivera-Martinez, who now is with

PARAXEL International Corporation. Two

speakers from Pfizer will speak here,

along with an invited FDA representative

to describe the agency’s new approach

relating to security throughout the

supply chain. Following the FDA speaker,

Brian Johnson, Senior Director, Supply

Chain Security for Pfizer will provide a

Pharma Company Example of Organizing

Supply Chain Security. He will be

followed by a presentation on Excipients

as Atypical Actives: How It Complicates

and Can Add Risk to Your Supply Chain.

This will be delivered by IPEC=-Americas

Immediate Past Chair, Janeen Skutnik-

Wilkinson, Director of Quality &

Regulatory Policy.

3rd Party Audit Solutions will be the

second June 7 morning session.

Dr. Wolfgang also will be speaking in

another session on Monday morning,

reporting on Applying Science to Safe-

guarding Materials: Initiatives with FDA.

This will be part of a session moderated

by IPEC-Americas Chair Dale Carter of

J.M. Huber entitled Risk Model: Materials

which also will include presentations by

Doe & Ingalls President & CEO John

Hollenbach, and Jared Byrne, Amgen

Senior Manager for Supplier Quality

Management.

Three other sessions also are planned for

June 6. One will deal with a Risk Model for

Finished Products which will be

moderated by Londa Ritchey. Her

speakers include an invited FDA

representative to discuss inspection

issues for contract manufacturing sites,

Lucy Cabral, Director, Quality Assurance,

Genentech Inc., and Susan Schniepp,

Quality Vice President for OSO

BioPharmaceuticals Manufacturing.

The second session will discuss Supply

Chain Tracking: Finished Products. FDA

reports on agency track and trace efforts

relating to finished products are planned,

as well as an industry summary by Ashley

Goldberg, Manager, Global Compliance-

Supplier Quality, Baxter Healthcare.

Current IPEC-Americas Chair Dale Carter

also is moderating a second session on

June 6. This will deal with Supply Chain

Solutions and includes two industry

presentations and another from FDA.

Page 14

IPEC-Americas News

This will be moderated by Matthew

Anderson, Director, Global Supplier

Quality Corporate Compliance, Baxter

Healthcare. During this session Dr. Irwin

Silverstein of IPEA and IBS Consulting will

discuss IPEA’s current excipient auditing

and auditing certification programs and

Dale Carter will report on the planned

EXCIPACT GMP/GDP certification system

for excipients. A report on the Rx-360

shared audit program and another

relating to auditing of materials made in

China also are planned for this session.

Following luncheon on Tuesday, two

concurrent sessions will be offered, one

dealing with Security of Raw Materials and

the other on Ensuring Secure Distribution

of Finished Product. In the first Joseph

Woodward, Global Director, Logistics &

Planning for Avantor Advanced Materials

will discuss Enhancing Security of

Materials: Practices from a Material

Supplier. This will be followed by a report

on Verification of Incoming Raw Materials

by Rod MacLea, Director, Supply Chain,

Amgen, Inc. An FDA speaker also has

been invited to discuss analytical

technologies around supply chain security

of materials.

Distribution management of finished

products is the focus of the second

concurrent session. Here Brad Elrod,

Pfizer’s Director of Conveyance Security,

will lead off by describing his

company’s practices for ensuring

product safety while in transit. Mr. Elrod

will be followed by a Federal Express

manager and an official of the National

Coalition of Pharmaceutical Distributors

who will detail their methods for

ensuring security while products are in

their control.

After these sessions, the closing

conference segment mentioned earlier

will take place, followed the next day,

Wednesday, June 8, by a PDA Training

and Research Institute Course:

Developing a Robust Supplier

Management Process. The instructor for

this course will be Lisa Hornback of

Hornback Consulting, LLC

For more information go to:

www.pda.org/supplychain2011

Supply Chain Security Also an Rx-360 Focus – at ExcipientFest!

On May 11, during ExcipientFest, the Rx-360 consortium is presenting an all-day

workshop entitled Increasing the Safety of the Supply Chain: A Pharmaceutical Consortium Approach.

Page 15 IPEC-Americas News

Four major segments will be included:

Emerging Regulations Facing the Pharmaceutical Industry and the Impact to

Suppliers

Barb Unger

Director of Global Quality Compliance

Amgen

Pharmaceutical Risk-Based Approach to Supplier Auditing

Andre” Littek

Manager, Global API Supplier

Auditing Product Supply-Compliance

Bayer Healthcare

Quality Management Systems

Claudia Ferriera

General Manager

Hovione

and

Ken Manning

Vice President-Quality

CIMA Laboratories

Rx-360 Approach to Shared and Joint Audits

Shared Audits: Ashley Goldberg

Manager, Global Compliance-Supplier Quality

Baxter Healthcare

Joint Audits: Andre” Littek

Manager, Global API Supplier

Auditing Product Supply-Compliance

Bayer Healthcare

Page 16

IPEC-Americas News

Important Industry Meetings

May 5-6

2011 CHPA Regulatory and Scientific Conference

Consumer Healthcare: Designing a Blueprint for Success

Hyatt Regency Hotel

Bethesda, Maryland

Register: www.chpa-info.org

May 9

IPEC-Americas 20th Anniversary Conference

Renaissance Harborplace Hotel

Baltimore, Maryland

Register: http://ipecamericas.org/content/ipec-americas-20th-anniversary-conference

May 10-11

ExcipientFest Americas

The Excipient Industry’s Best Expo for Regulatory Science and Sourcing Education

Renaissance Harborplace Hotel

Baltimore, Maryland

Register: http://www.excipientfest.com/

May 13

FDA/DIA Workshop on Best Practices for the Prevention of Cargo and Warehouse Theft of FDA

Regulated Medical Products and Infant Formula

Hilton Washington, D.C./Rockville

Rockville, Maryland

Register: www.diahome.org Event# 11036

May 16-18

2011 AAPS National Biotechnology Conference

Hilton San Francisco Union Square

San Francisco, California

Register: www.aapspharmaceutica.com/nationalbiotech

Page 17 IPEC-Americas News

June 6-7

2011 PDA Pharmaceutical Supply Chain Conference

Bethesda North Marriott Hotel and Conference Center

Bethesda, Maryland

Register: http://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/2011-

PDA-Pharmaceutical-Ingredient-Supply-Chain-Workshop.aspx

June 15-16

NIPTE Research Conference – Critical Path Research for Pharmaceutical

Process Scale-Up and Stability

The Universities at Shady Grove Conference Center

Rockville, Maryland

Register: www.nipte.org

June 19-23

Drug Information Association (DIA) 47th Annual Meeting

Convergence of Science, Medicine and Health

McCormick Place West

Chicago, Illinois

Register: www.diahome.org/registerDIA2011

June 20-21

The NIPTE 13th Annual FDA and the Current Challenges of GMPs Conference

Hyatt Regency Bethesda

Bethesda, MD

Register: www.pharmaconference.com

IPEC-Americas May Committee Meeting Schedule

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IPEC-Americas News

IPEC-Americas May Committee Meeting Schedule

All meetings will take place at the offices of

Buchanan Ingersoll & Rooney

1700 K Street, N. W., Washington, D.C. 20006 May

Monday, May 23 Executive Committee 10:00am – 5:00pm Tuesday, May 24 Quality by Design 8:15am – 12:00pm EIP Working Group 8:00am – 12:00pm Lunch – 12:00pm

Excipient Composition 1:00pm – 5:00pm Validation Working Group 1:00pm – 5:00pm

Wednesday, May 25 Good Manufacturing Practices 8:15am – 12:00pm Lunch – 12:00pm Excipient Qualification 1:00pm – 5:00pm General Update 5:30pm – 8:00pm Thursday, May 26 Compendial Review 8:15am – 12:00pm

Lunch – 12:00pm Regulatory Affairs 1:00pm – 5:00pm NSF Excipients Standard 8:00am – 5:00pm