IPEC-AMERICAS NEWS. Chair s Note: An Active Year for Excipients. Page 1 INSIDE THIS ISSUE

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1 Page 1 IPEC-AMERICAS NEWS IPEC-Americas, Inc., 1655 North Fort Myer Drive, Suite 700, Arlington, VA ipecamer@aol.com, Tel: IPEC-Americas January2011 News z 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 drug product manufacturing. Through IPEC s Legislative Initiative we provided education and information to law makers and staff to help them create realistic legislation providing workable solutions to ensure public safety. If the language in this law finds its way into a drug safety bill, our efforts in establishing IPEA and working with the ANSI NSF 363 and Excipact committees will provide our member companies a compliance option INSIDE THIS ISSUE Chair s Note: An Active Year for Excipients 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 Release...4 Designing a Blueprint for Success The 2011 CHPA Regulatory and Scientific Conference..5 ExcipientFest 2011 Exhibitors Sold Out! IPEC-Americas 20 th Anniversary Conference...7 Upcoming PDA Workshop on Atypical Active Ingredients IPEC-Americas 2011 Web-Based Training..10 IPEA Workshops Important Industry Meetings IPEC-Americas Committee Meetings...14 of reasonable audit programs based on our well established Excipient GMP guidelines. Now more than ever we need the Legislative Initiative to continue so that the IPEC position will be heard. Many thanks to our immediate Past Chair, Janeen Skutnik- Wilkinson, for championing this initiative and to all our member companies who are supporting this effort.

2 Page 2 IPEC-Americas News As we look forward into 2011, our IPEC 20 Year Anniversary Conference shines brightly on the horizon of spring with a great speaker line up capped off with the IPEC Foundation Gala Dinner. This May 9 th event at Baltimore s Inner Harbor inculcates IPEC s collective experience and knowledge into presentations that will enlighten participants, preparing a firm foundation from which to implement Total Excipient Control. Past Chair Dave Schoneker leads our speakers list for a morning that brings together the concepts from IPEC s guidelines to form a system for Total Excipient Control. Following the coffee break we leap beyond the indubitable safety arguments for excipient control into examining economic justifications and ROIs for manufacturing investment. IPEC s legal counsel from Buchanan Ingersoll and Rooney provides a historical perspective into Lawsuits and Liability. The afternoon charges ahead examining excipient control in distribution services with a powerful presentation by Dwight Mutchler of Mutchler Inc. followed by insightful presentations on emerging international issues in the excipient world. This perfect day ends with the razzmatazz of our IPEC Foundation Gala Dinner featuring The Capitol Steps and recognition of our past chairs. Bring some walking money because we re running a 50/50 raffle to raise money for the IPEC Foundation Graduate Student Awards. I look forward to seeing participants from all of our member companies and encourage everyone to stay for ExcipientFest Americas on May 10 th and 11 th. IPEC is please to again sponsor ExcipientFest as it travels this year from Puerto Rico to Baltimore s Inner Harbor. The great presentations and exhibits scheduled for this year s ExcipientFest truly makes the science the fun. EXCIPACT Global Steering Team Holds Face to Face Meeting in Cannes The Excipact Global Steering Team consisting of member representatives from the five founding organizations (IPEC Europe, EFCG, PQG, IPEC-Americas, and FECC) met in Cannes to set Excipact milestones for 2011 and to refine the business and marketing plans. Excipact is a third party auditing program using a standard for excipient GMP and GDP certification designed as an annex to the ISO 9001 Quality System. The IPEC PQG Excipient GMP and the IPEC GDP guidelines form the basis for this standard that will be equivalent to the ANSI NSF 363 GMP for Pharmaceutical Excipients currently under development. The Global Steering team serves as the final approving body for the Excipact standard.

3 IPEC-Americas News Page 3 The Excipact program allows excipient manufacturer and distributor companies to include GMP or GDP certification as part of their ISO 9001 registration audits. The basic business plan involves ISO 9001 third party auditing companies providing GMP or GDP certifications under license agreement with Excipact following the guidelines and controls given in the Excipact standard manual. When a company successfully completes an Excipact audit as determined by a review board within the third party auditing company, the Excipact organization issues a certificate and posts the company s name to the Excipact web site. 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 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 project with the Global Steering Team remaining intact and the project plan proceeding as currently written. The Excipact working groups for GMP, GDP, and Auditor Competency also met on the following day to incorporate the review comments of the standard manual by the five member companies. The Excipact plan is targeting a public stakeholder review of the standard manual during the first part of this year and a launch of the Excipact certification program by the end of To this end the Global Steering Committee divided oversight responsibilities for the individual project aspects to individual team members and set a schedule of bimonthly review calls to ensure the project legs move in tandem. Development of Guidance to Evaluate Particles Present in Excipients is Next IPEC-Americas Committee Project Following a recommendation by IPEC- Americas member company Apotex Inc. and review of research supplied by the company, IPEC-Americas members who participated in a January 18 teleconference agreed to form a working group to develop industry guidance for the detection and evaluation of particles found to be present in excipients prior to their use in a finished drug s manufacturing process. This will be led by Ms. Ruth Moses-Kogut, Manager, Supplier Quality, AGO-QA, Apotex Inc.

4 Page 4 IPEC-Americas News The new project will be initially reviewed and evaluated in the February 23 Excipient Composition Working Group meeting. It is expected that one of the group s first steps will be to review current USP, FDA and other available international regulatory and pharmacopeial information pertaining to particles presence in drugs and drug components, foods and cosmetics. Current practices employed by excipient makers and users on a global basis also will be reviewed and evaluated, members who participated in the telecon report, thus it is hoped that additional IPEC- Americas full members and associate member distributors can be represented at the February 23 Excipient Composition Working Group meeting in Washington, D.C. January Member Announcements and News Release Generichem Corporation Generichem announced January 13 that Eric B. Oishi has been appointed its President and Chief Operating Officer. Mr. Oishi joined Generichem in 2007 and has held management positions in sales, operations, and new product development. Prior to joining Generichem, he was involved in sales and marketing at IBM and Boston 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. Generichem s major product lines include pharmaceutical APIs, excipients and minerals. The company represents quality manufacturers from around the globe including Katwijk Chemie, Tomita Pharmaceutical, Ferropharma, Nitika, Kelatron and many others. The company is headquartered in Totowa, New Jersey and has national distribution capabilities. Founded in 1976, Generichem is a leading supplier of raw materials to the pharmaceutical, nutrition, food and beverage and cosmetic industries.

5 IPEC-Americas News Page 5 Designing a Blueprint for Success The 2011 CHPA Regulatory and Scientific Conference Registration is available for the 2011 CHPA Regulatory & Scientific Conference (RSC). This year s meeting will be back at the Bethesda Hyatt Regency, Bethesda, Maryland, on May 5-6. Using a theme of Designing a Blueprint for Success, attendees will hear about current issues and future trends affecting OTC products and dietary supplements. In 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 regulatory considerations associated with utilizing probiotics in OTCs and dietary supplements. Speakers from FDA s Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health will join Andy Fish, AdvaMed Diagnostics (and formerly of CHPA), to share information about the intersection of medical devices and consumer self-care products. The CHPA website will be updated as program details become available. Don't miss the chance to hear about trends and opportunities in consumer healthcare. Online registration is available now. Register at: 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 10 th & 11 th, 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.

6 Page 6 IPEC-Americas News On May 9, IPEC-Americas one-day Regulatory Conference will precede ExcipientFest. This affiliation brings added-value to Educational Program while increasing attendee, exhibitor and FDA participation. INDUSTRY'S BEST PHARMA-TECH EVENT NOW IN ITS 11th YEAR Celebrate IPEC s 20 th Anniversary America s Educational & Networking Marketplace for Pharma Ingredients & Fine Chemicals. RESERVE YOUR PLACE

7 IPEC-Americas News Page 7 IPEC-Americas 20 th 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: $ IPEC-Americas Member company Employees $ Non-member Employees $175 government/academic $50.00 Student $ 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, Table for eight, banners and signage - full page in program Ruby - $3, Dinner for four, preferred seating, banners, signage and program recognition. Emerald - $1, Dinner for two, preferred seating, signage, and program recognition.

8 Page 8 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 glycerin what do all these have in common? Not sure? Well, all three are commonly used as excipients and/or adjuvants in drug products. But as they say in the TV commercials Wait There s More. All may be active ingredients in drug products. Normal saline, hand sanitizers and Glycerin Suppositories would all list these as active ingredients. They are not typically considered to be such, but in some circumstances they may become Active Pharmaceutical Ingredients (APIs). So if they are not typically considered to be APIs, what are they when used in products such as those mentioned above? They are, in fact, Atypical Active Ingredients. Why is that important? Well, as I m sure we are all aware, the manufacture of APIs is required to be done in compliance with Current Good Manufacturing Practices. This means that, taken literally, these APIs must be manufactured in compliance with the criteria in ICH Q7, the Good Manufacturing Guide for Active Pharmaceutical Ingredients. How realistic is that? Do the manufacturers of these and other Atypical Active Ingredients, who prepare literally thousands of tons or more of these chemicals, do so in compliance with Q7? We are not in that business, but if asked to speculate, we would guess not. What would happen if they needed to comply with all the criteria of ICH Q7 to continue to supply the pharmaceutical industry? Would their business model support the costs associated with the additional controls necessary to comply with all the Q7 criteria? Again, we can only speculate, but we would guess not. What then would happen to the drug products using these Atypical Active Ingredients? Continued speculation leads to the possibility that they might disappear from the market. Recognizing this dilemma, PDA and the FDA have combined to develop a Workshop on Atypical Actives. This Workshop, to be held in Bethesda, MD March 9 10, 2011 will explore the complex issues and questions surrounding the manufacture and use of these compounds. The Workshop will feature plenary sessions on Day 1, allowing users of Atypical Actives and regulators to provide their perspectives. Legal aspects will also be covered in a Day 1 plenary session, as will a discussion of some of the sourcing and marketing issues associated with these compounds.

9 IPEC-Americas News Page 9 Following a discussion of case studies on Day 2 presented by manufacturers, users, and regulators, the Workshop will split into breakout sessions where the real work of the Workshop will take place. Attendees will have the opportunity to discuss the technical considerations and regulatory considerations associated with the manufacture and use of Atypical Actives. The Workshop will be structured so these breakouts are repeated a second time, thus allowing attendees to participate in both. 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 desirable attributes of the Washington, DC area and most of all, the critical importance of this topic make attendance an absolute must if you are involved in the manufacture, use or regulation of Atypical Active Ingredients, including those involved with purchasing, supply chain and contract manufacturing operations, as well as more traditional functions such as manufacturing, quality assurance, and regulatory affairs. Visit the Workshop website, for 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 Association Maria Guazzarini Jacobs, Ph.D. Pfizer Inc. Iain Moore, Ph.D., Croda Europe Alexa Smith, Colorcon

10 Page 10 IPEC-Americas News IPEC-Americas 2011 Web-Based Training Learn from the experts! Register now for the second series of educational webinars beginning February, 2011!! Five educational modules covering a variety of topics critical to manufacturers and users of pharmaceutical excipients will feature industry professionals and experts as presenters. February 15: Significant Change - How to understand and evaluate changes involving the manufacture of pharmaceutical excipients and when reporting is needed. May 17: Stability Methods and rationale for determining excipient stability; IPEC s common sense scientific approach to stability studies for excipients stored and transported via uncontrolled conditions. Presenter: Philip Merrell Ph.D., Technical Marketing Manager, Jost Chemical Company June 21: Validation Learn about IPEC s needed validation guideline on manufacturing processes, analytic methods and cleaning. Presenter: Dave Schoneker, Director Global Regulatory Affairs, Colorcon Presenter: Ann Van Meter, Senior Quality Systems Specialist, Dow Wolff Celluosics March 15: Certificates of Analysis - Overview of IPEC s revised guideline based upon changing regulatory requirements. Presenter: John Giannone, Business Development Manager, Cognis Corporation April 12: Excipient Pedigree - Why and how an understanding of the supply chain history of excipients is critical to the safety of drug products. Presenter: Linda Herzog, Marketing Director, Asahi Kasei America Pricing: Discounts offered for participation in all five modules $ for members of IPEC-Americas Member Companies - $ for Nonmembers. Interested in one specific topic? Sign up for one session! $75 for IPEC-Americas Member Company Employees $150 for Non-members Best Value Sign up for all five sessions and save hundreds! Register NOW at

11 IPEC-Americas News Page 11 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 requirements. Workshop Leaders Drs Art Falk and Irwin Silverstein Registration is currently open and available on line, but hurry this class is already half full! Register now by going to this link: p11.htm Course Overview: Assessing GMPs for Excipient Manufacture Where GMPs Begin Audit Planning Pre-audit Questionnaires Alternative Audit Approaches Audit Checklists & Techniques Necessary Auditing Interpersonal Skills Defining Pertinent Audit Issues In Observations Writing & Rating Observations Excipient Manufacture Requirements vs. APIs Hands-On Mock GMP Audit Workshop Schedule: Tuesday 4/5/2011 Registration first day 8:00-8:30am Tuesday-Thursday Workshop Sessions 8:30am-4:30pm Validation Workshop: taking place at IPEA s central office location in Arlington, VA on April 7-8, This workshop consists of two half day sessions and will take place at the close of the Excipient Auditing Workshop, so register for both classes!! Validation is the key element in assuring that quality assurance goals are met and a consistent excipient quality is regularly achieved. The scope of this workshop includes removing some of the misunderstanding and preconceptions concerning validation. Workshop Leader Sidney A. Goode, PharmD

12 Page 12 IPEC-Americas News 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 data Management of changes Addressing re-validation Writing the final report 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: hop.htm For questions about either workshop: please contact Valeria Stewart at IPEA, Inc. at or 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: February GPhA 2011 Annual Meeting Hilton Orlando Bonnet Creek Orlando, Florida Register:

13 IPEC-Americas News Page 13 February PQRI Workshop Threshold and Best Practices for Parenteral and Ophthalmic Drug Products Hyatt Regency Bethesda Bethesda, Maryland Register: February 28 - March 2 Personal Care Products Council Annual Meeting The Breakers Palm Beach, Florida Register: March 9-10 PDA/FDA Atypical Actives Workshop Coming Together to Develop Solutions Hyatt Regency Bethesda, Bethesda, MD Register: March CHPA Consumer Healthcare Products Association Annual Executive Conference The Fairmont Turnberry Isle Resort & Club Aventura, Florida Register: March th 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:

14 Page 14 IPEC-Americas News IPEC-Americas Committee Meetings - February Tuesday, February 22 Executive Committee (by invitation only) 12:00pm 5:00pm Wednesday, February 23 Quality by Design Excipient Composition Validation Working Group 8:15am 12:00pm Lunch 12:00pm 1:00pm 5:00pm 1:00pm 5:00pm Thursday, February 24 Good Manufacturing Practices EIP Working Group Lunch 12:00pm Excipient Qualification General Update 8:15am 12:00pm 9:00am 12:00pm 1:00pm 5:00pm 5:30pm 8:00pm Friday, February 25 Compendial Review Regulatory Affairs NSF Excipients Standard Lunch 12:00pm 8:15am 12:00pm 1:00pm 5:00pm 8:00am 5:00pm