IPEC Regulatory Affairs Conference
Monday September 15th -Tuesday September 16th at the Embassy Suites in Old Town, Alexandria, VA
-Details now available- click here
IPEA GMP Auditing Workshop To Be Held In Houston
A comprehensive three day excipient GMP Auditor Training Workshop offered by International Pharmaceutical Excipients Auditing (IPEA) will be held September 23-25, 2008 in Houston, Texas. Hotel information TBD. IPEA is IPEC-Americas GMP auditing subsidiary company that also conducts on-site training for company auditors and workshops on a global basis using the IPEC-PQG GMP Guide and related materials.
The Houston workshop on excipient auditing is designed to benefit both makers and users of pharmaceutical excipients. Training will analyze the essential elements of excipient good manufacturing practice for materials intended for use in pharmaceuticals, dietary supplements, food, or as industrial chemicals and explains how applicable product standards differ.
The workshop also will focus on excipient GMP compliance and attendees will learn auditing techniques, report writing, observation, and classification techniques that relate to the manufacture of excipient ingredients. It contains exercises to hone observation skills through participation in a hands-on mock excipient GMP audit. Participants also gain a thorough understanding of risk-based excipient auditing and learn how to assess whether an excipient GMP quality system can achieve a satisfactory level of compliance. Finally, attendees learn how to differentiate the requirements for excipient manufacture from those of APIs.
The three-day auditing workshop will be facilitated by Dr. Arthur Falk, IPEA President and Chief Executive Officer and Dr. Irwin Silverstein, IPEA Vice President and Chief Operating Officer.
For more information and for registration details –please contact Kim Beals at ipeainc@aol.com or visit the IPEA website at www.ipeainc.com .
IPEC-Americas 2007 Regulatory Affairs Conference Presentations
Presentations from the 2007 Regulatory Conference held September 10 - 11, 2007 at the Embassy Suites Hotel in Alexandria are available by clicking on the following links:
The New IPEC and Where We Are Heading
David R. Schoneker, Colorcon
IPEC-Americas New Excipient Evaulation Program
Jay M. Goldring, PH.D., Wyeth
The Future For ICH and Compendial Harmonization: An Industry Perspective
Janeen Skutnik, Pfizer
Excipient GMPs - Are Regulations Coming
Patricia Rafidison, Ph.D., IPEC Europe
Sidney A. Goode, Dow Chemical Co.
Excipient Testing, Control and Communication: Findings of a PQRI Working Group
Phyllis Walsh, Schering-Plough
William Dale Carter, Archer Daniels Midland
Robert E. Wiens, Eli Lilly & Company
Jon Clark, Ph.D., OPS, CDER, FDA
Barry Rothman, OC, CDER, FDA
Update on FDA Acticities Regarding DEC Contamination in Glycerin
Edwin Rivera-Martinez, OC, CDER, FDA
The Future for ICH and Compenidal Harmonization: A Pharmacopoeial Perspective
Catherine M. Sheehan, USP
Henk de Jong, Ph.D., European Pharmacopoeial Commission
Excipient Qualification Program
Maria Guazzaroni Jacobs, Ph.D., Pfizer
Alexa Smith, Colorcon
David B. Klug, sanofi-avantis U.S. LLC
Quality By Design Implications of Excipients
Prabir K. Basu, Ph.D., NIPTE
Just Released!
The Joint EPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients 2007. Currently available for purchase. Order online through our secure system or contact Tammy Kramer for assistance: 703-351-5265.
IPEC-Americas new guidance on qualification of excipients for use in pharmaceuticals - the Phase One Guideline which covers:
The Excipient Manufacturer's Process!
This details necessary steps a chemical manufacturer should take to evaluate a pharmaceutical market for his material and the regulatory requirements for the proposed excipients and what needs to be done before marketing it.
Future documents already under development will cover the User's Process (Phase Two) for evaluating the excipient and its manufacturer before using it in a formulation and the Negotiation Process (Phase Three) between the excipient producer and a potential pharmaceutical company user.
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:
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Proper Selection and Use of Excipient Performance Tests (addressing functionally);
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Adequacy of pharmacopeial monographs to meet these changing requirements;
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Development of robust formulations as per QbD/PAT
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Minimizing perceived regulatory barriers to introduction and use of co-processed excipients;
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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 Functionality
by 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.
Revised Guidance Published
The joint IPEC/PQG GMP Guide for Pharmaceutical Excipients is now available. This guide was developed in conjunction with IPEC Europe and the Pharmaceutical Quality Group (PQG), a U.K. based industry organization. The new guide is closely tied to ISO9001 and updates earlier IPEC and PQG guidance.
Another IPEC accomplishment is a new IPEC Good Distribution Practices Guide for Pharmaceutical Excipients. This also was developed jointly with IPEC Europe and was written to provide additional guidance for international companies involved in the excipient supply chain beyond that which is contained in the 2003 World Health Organization’s technical report entitled “Good Trade and Distribution Practices for Pharmaceutical Excipients.”
To purchase these and other IPEC-Americas guidance, please click below:
Buy on-line through our secure network or off-line
If you need assistance, telephone Kim Beals, IPEC-Americas Executive Director of Member Services at 703-875-8712.
Excipient Information Protocol
The Excipient Information Protocol User Guide is now available for downloading from IPEC-Americas home page.
Website Information
IPEC-Americas Product
Security Statement
IPEC-Americas has developed
a statement on the subject of product security and avoidance
of product tampering throughout the entire excipient manufacturing
and product delivery cycle. Please click on the following
link to access this document.
IPEC-Americas
Product Security and Tampering Statement
IPEA Third Party Auditing
Program
International
Pharmaceutical Excipients Auditing Inc. (IPEA), an
IPEC-Americas subsidiary, provides current good manufacturing
practices (cGMP) auditing services for pharmaceutical excipient
suppliers and their customers. Audits are conducted by IPEA-trained
auditors based on the internationally-accepted IPEC Good Manufacturing
Practices Guide for Bulk Pharmaceutical Excipients.
IPEA's partner
in the auditing program is the Labtest division of Intertek
Testing Services, Inc., a global company with over 10,000
employees and offices in 77 countries. Auditing services are
available throughout North America, Europe, and Australasia
by certified personnel usually based in the countries where
audits will be conducted and thus conversant in many of the
local languages.
Additional
details are available from IPEA's chief operating officer,
Irwin Silverstein, Ph.D., who is based in Piscataway, New
Jersey. Tel: 732-463-8710 or by email to
irwin.s@att.net
www.ipeainc.com
IPEC-Americas Guidance
Documents Available for Purchase
The following
is a list of current IPEC-Americas Publications
Qualification of Excipients for Use in Pharmaceuticals
(© 2007)
IPEC/PQG GMP Guide
for Bulk Pharmaceutical Excipients (© 2006) -- Also Available in
Pocket Size
IPEC-Americas GMP
Audit Guideline for Bulk Pharmaceutical Excipients (© 2004)
IPEC Good Distribution Practices Guide (© 2006)
Significant Change Guide for Bulk Pharmaceutical Excipients
(© 2005)
Certificate of Analysis Guide for Bulk Pharmaceutical Excipients (© 2000)
IPEC-Americas Excipient Master File Guide (© 2004)
Excipient Information Protocol User Guide (© 2005)
Copies may
be ordered from Kim Beals, at the
IPEC-Americas headquarters office, Tel. 703-875-2127, Fax
703-525-5157, or email at info@ipecamericas.org. Member company representatives and employees receive a
50% discount.
Click on the following link to order guidance documents
on or off-line. IPEC-Americas accepts VISA, MasterCard and
American Express Credit Cards through our secure network.
IPEC-Americas
Guidance
