What's New at IPEC-Americas, Inc.

IPEC-Americas (International Pharmaceutical Excipients Council) and the Coalition for the Monitoring of Melamine Contamination (CHPA, GPhA, IPEC, PhRMA, SOCMA) has partnered with RX-360 and generated a set of templates that can be used to communicate with suppliers and contract manufacturers and to gather information pertinent to material controls that are in place to prevent melamine contamination of raw materials. Surveying suppliers and contract manufacturers is a method that companies may choose to do as part of addressing the FDA Guidance to Industry: Pharmaceutical Components at Risk for Melamine Contamination. These templates can be accessed by clicking on the links below and can be copied onto your company's letterhead.

It is recommended that excipient users utilize these templates when initiating a dialog with suppliers and contract manufacturers about the potential for melamine contamination in their products. It is important that you DO NOT just send these templates out to all of your suppliers for every excipient. This will just result in a lot of non-value work on everyone's part. Instead, this letter and form should ONLY be sent to suppliers of excipients which are either listed in the FDA's new guidance on Melamine or are materials where there may be some significant chance of there being a true risk such as the fact that the testing for the product contains a nitrogen assay.

It is also recommended that excipient suppliers and distributors put together their responses in the same format as the Sample Form so that all the appropriate questions are adequately answered. This will help to expedite everyone's efforts and will minimize the need for multiple requests for the appropriate information to understand what is needed.

These letters and the form are also available on the Rx-360 website at: http://www.rx-360.org/.

Throughout the world, new or novel excipients are only approved within new drug applications, and there is no independent regulatory approval process for new excipients. In 2007 IPEC-Americas Safety Committee proposed and developed the IPEC Novel Excipient Evaluation Procedure. This independent excipient evaluation process is anticipated to reduce the cost and uncertainty related to use of novel excipients in pharmaceutical formulations, thereby encouraging their use in drug development programs and expanding drug formulation innovation.

The goal of the IPEC Novel Excipient Evaluation Procedure is to provide an independent evaluation of the safety and regulatory acceptance of a new excipient before a regulatory filing. The process is meant to mirror that of regulatory agencies, ideally providing confidence to pharmaceutical manufacturers that the excipient will be acceptable in their formulations.

For additional information please read the November 2009 Pharmaceutical Technology Position Paper authored by Christopher DeMerlis, Jay Goldring, Ph.D., Ranga Velagaleti, Ph.D., William Brock, Ph.D., and Robert Osterberg, Ph.D.

Pharm Tech November 2009 Article

IPEC-Americas to Sponsor On-line Open Journal

IPEC-Americas has agreed to sponsor a peer reviewed scientific journal which will be dedicated to excipients. This journal will be an on-line open-access journal published by IPEC, titled the Journal of Excipients and Food Chemicals (JEFC). JEFC will publish research articles, research reports, technical notes, scientific commentaries, news, views and review articles related to the physical, chemical biological, biotechnological, clinical and scocioeconomic-pharmacoeconomic as well as regulatory aspects of pharmacetucal excipients and food chemicals.

The scope of the journal is to offer a unique forum for the discussion and communication of research, reviews or commentary related exclusively to excipient materials. It is hoped that the journal will be launched by the second quarter of 2010. To access the journal website, please click here:

https://ojs.abo.fi

On June 18, following initial meetings of the newly-formed IPEC Federation, representatives of IPEC-Americas and IPEC China had an opportunity to meet in Beijing with key leaders of the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), an SFDA department. During the meetings IPEC-Americas was represented by Immediate Past Chair David Schoneker of Colorcon and Chair-Elect Dale Carter of JM Huber Engineered Materials. IPEC China was represented by its current Chair, Nevin Cheng of Colorcon. Four agreements were reached during the full day of meetings, which also included a tour of NICPBP’s Pharmaceutical Excipient and Packaging Material Laboratory.

Due to a recent incident where poor quality talc containing asbestos was found in drug and cosmetic products in the Korean market, the Korean Food and Drug Administration (KFDA) has recently drafted a proposed DMF requirement for Talc. Recent collaboration between IPEC-Americas and IPEC Europe resulted in the development of formal comments to Mr. Nam-su Kim in the Pharma Safety Bureau of the KFDA. These comments provide background about IPEC and IPEC's position of why implementation of a DMF system as proposed will not resolve compliance based issues. The letter also suggests an alternative approach that incorporates appropriate supplier qualification and compendial testing throughout the supply chain as the best solution to address the issue.

Final approval was granted this month by IPEC-Americas and IPEC Europe leadership to issue a new Quality Agreement Guide and Template as IPEC guidance. The document offers best practices and guidance in establishment of agreements between a buyer and a supplier of an excipient.

Quality agreements are intended to be formalized joint agreements on quality responsibilities and activities which define the parties respective obligations. The template is designed to be global in scope so it may be used in different regions. The excipient manufacturer’s template is for use between the original manufacturer and either the end user or a distributor. The distributor template is intended for use between a distributor and only the end user. As with any agreement intended to be binding, it is recommended that advice of legal counsel be obtained by all parties involved. A copy of the IPEC Quality Agreement Guide and Template can be downloaded from the IPEC-Americas home page at www.ipecamericas.org and click on the brown box that says Download IPEC Guidance Documents. After filling in the registration form click on the red button for

Excipient Qualification Programs. Also new for 2009, updated Significant Change Guidance - posted under IPEC Excipient GMP Related Guidance!

During its most recent meeting on May 18, IPEC-Americas Executive Committee members approved a legal memorandum from counsel that pertains to current debarment provisions of the Federal Food, Drug and Cosmetic Act as a statement of policy to request members to follow those provisions, thereby insulating themselves and their drug applications from possible civil penalty.

Several IPEC members were presenters at this years ExcipientFest Americas, April 22 - 23 in San Juan, Puerto Rico! Click on the link below to access the ExcipientFest website and to view presentations available for download.

Industry Coalition Guidance on USP General Chapter <467> Residual Solvents including FDA Responses from
November 7, 2008 Teleconference

Lou Blecher, 81; one of IPEC's founding fathers, passed away November 25, 2008. From IPEC's founding in 1991, Lou spent a great deal of his time doing what he loved, telling people about IPEC and its members’ mission.

He is sorely missed, and IPEC members will always be grateful for what he gave of himself to the organization he largely created.

If you would like to make a contribution to the IPEC Foundation in memory of Lou please visit the Foundation website at:

IPEC-Americas

Interested in more information about IPEC-Americas, who we are, what we do? Click here to download the IPEC-Americas electronic brochure.

Download IPEC-Americas brochure

Guidance on Qualification of Excipients for Use in Pharmaceuticals

This newly-expanded IPEC guidance, updates a 2007 document and outlines the three separate phases of the excipient qualification process, e.g.

the excipient suppliers' process;

the users' process; and
the negotiation process which involves excipient manufacturers, distributors and others in the ingredient supply chain and those ultimately responsible for the quality and safety of excipients used, i.e., companies that use them in their finished pharmaceutical formulations.

Each phase of the process also is described by a flowchart which illustrates the various steps included in evaluating the ingredient and customer/regulatory requirements for its use.

To download single PDF copies at no cost you will need to fill out the registration page which will take you to the guidance documents:
Click here for free guidance downloads

Go here to purchase one or more hard copies:
http://www.ipecamericas.org/mcart/index.cgi/

Acronym Table

Click here for an acronym table with abbreviations for some common regulatory bodies and technical terms.

FDA's "Guidance for Industry: Testing of Glycerin for Diethylene Glycol

IPEC-Americas strongly supports FDA efforts and emphasizes in all our guidance documents that integrity must be maintained throughout the chain of custody of pharmaceutical ingredients. To view FDA's Guidance, click on the following link.

http://www.fda.gov/cder/guidance/7654fnl.htm

For additional information, please review Dr. Arthur J. Falk’s 1998 Pharmaceutical Technology Magazine article on Qualification of Excipient Vendors (click here).

USP Food Chemicals Codex Frequently Asked Questions (FAQ's)

Roger L. Williams, MD Exective Vice President and Chief Executive Officer of the US Pharmacopeia has requested IPEC's assistance in the revision process of the Food Chemical Codex. Please click on the link below to access the USP's frequently asked questions about the FCC and the initial revision process.

USP's FAQ's click here

IPEC-Americas QbD Product Development Committee

As part of the ongoing Excipient Technical Applications Initiative, IPEC- Americas has created a new working committee, the "Quality by Design Product Development Committee" chaired by Dr. Brian A. Carlin, FMC BioPolymer.IPEC-Americas has been very successful in the Excipient Regulatory Area with its series of guidance on GMPs, Safety, DMFs, etc. for pharmaceutical excipients, and will continue to work to expand and update these important projects necessary. However the pharmaceutical development environment is changing rapidly in the light of initiatives such as PAT and QbD.The goal of Quality by Design is the development, with appropriate scientific rationale, of robust products and processes, encompassing materials, formulations, processes and applications. This will enable a reduction in the burden of regulatory oversight currently applied to changes in registered products, ultimately leading to continuous improvement and perhaps even continuous production. To reach the desirable state a number of issues need to be addressed:

Proper Selection and Use of Excipient Performance Tests (addressing functionally);

Adequacy of pharmacopeial monographs to meet these changing requirements;

Development of robust formulations as per QbD/PAT

Minimizing perceived regulatory barriers to introduction and use of co-processed excipients;
Reducing barriers to excipient user-supplier collaboration to build on the shared knowledge base.

With the establishment of this new Working Committee IPEC-Americas is looking for volunteers with the appropriate scientific expertise to foster the development of robust formulations and facilitate shared design across the user-supplier interface. This is not restricted to regulatory specialists. Formulation and development scientists from both users and manufacturers of excipients are encouraged to serve on this new QbD Product Development Committee.

If interested please contact the IPEC-Americas Office (Kim Beals or Alan Mercill) at 703-875-2127.

Pharmaceutical Technology Special Report
Debating Excipient Functionalityby Maribel Rios

Click here to access pdf file

IPEC/PQG Position on Supplier Certification

The following statement is intended to provide clarification regarding certification of excipient manufacturers based on the 2006 IPEC/PQG GMP guideline. The IPEC/PQG Guide is a guideline for the application of the principles of good manufacturing practices to excipients; it is not a standard since minimum conformance criteria were neither intended nor established. Therefore the Guide cannot and should not be used for certification purposes. While it is recognized that a third party may elect to use the IPEC/PQG Guide as a basis for auditing a client, the collaborating authors (IPEC-Americas, IPEC-Europe and The PQG) stress that the Guide is not a certifiable standard and we do not recognize any form of certification produced as a result of such an audit.

IPEC-Americas Product Security Statement

The IPEC-Americas WebBoard is operational for IPEC committees and working groups! In order to access the WebBoard, members will need to go to the "Member's Lounge" area and click on "WebBoard." New users will be asked to register by supplying your name and email address and a login name (your company or last name would be appropriate). After this information is submitted, a password will be emailed to you (usually within 15 minutes).Once logged in to the WebBoard, please look around and familiarize yourself with how to maneuver within the Board and check out what is already posted. It is available for use by all committees, working groups and subcommittees to post drafts and comments and to finalize committee recommendations and position papers.The WebBoard is intuitive to use and offers online Help for all major features. If you have questions about a feature, look for the "Help" button on the menubar, or contact Kim Beals at info@ipecamericas.org.