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Excipient Pedigree Position Paper

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New Quality Agreement Guidance Receives Final Approval

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!

 

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New Policy Statement on Debarment

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.

IPEC Debarment Paper

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ExcipientFest Presentations

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.

www.excipientfest.com/americas/index.php

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Newly Posted:

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

Click here to Review and Download

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Janeen Skutnik to Speak at ISPE's Washington Conference

Janeen Skutnik, IPEC-Americas Chair, will be one of the Session Leaders for the Global Supply Chain Integrity and Anti-Counterfeiting session to be held June 3-4 as part of ISPE's Washington Conference.

Just Announced: "US FDA Speakers Figure Prominently at ISPE's 2009 Washington Conference.....click here to read the press release!"

Click here for the ISPE website

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SAVE the Dates!
CHPA-FDA Industry and IPEA Workshop

The next FDA/PAN Industry Technical Workshop will take place July 28, 2009 at the Hyatt Regency Hotel Downtown, Chicago, Illinois. Click here for more information and for the registration page.

FDA/CHPA Registration

An IPEA Third-Party Auditing Workshop will take place immediately following, July 29 - 31. Dr. Arthur Falk, IPEA President and Chief Executive Officer, and Dr. Irwin Silverstein, IPEA Vice President and Chief Operating Officer, will facilitate the workshop which offers a two day educational session with an optional third day hands-on workshop.

For additional information or to register for the IPEA workshop, please contact Valeria Stewart at ipeainc@aol.com.

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USP International Excipient Workshop
Excipient Quality Control, Testing, and International Harmonization

This workshop will highlight issues and challenges surrounding the global sourcing of exciients from a safety and quality control perspective and the currrent status on excipient regulation.

For additional information visit the USP's website at:

http://www.usp.org/meetings/workshops/internationalExcipient
Workshop.html

Or download the flyer and preliminary program here:

USP International Excipient Workshop Flyer

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In Memorium
Lou Blecher
1927 – 2008

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:

http://www.ipecfoundation.org

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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

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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.
  

  
  

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Acronym Table

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

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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).

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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

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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.

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Pharmaceutical Technology Special Report
Debating Excipient Functionality

by Maribel Rios

Click here to access pdf file  

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IPEC/PQG Position on Supplier Certification  

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IPEC-Americas Product Security Statement