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What IPEC-Americas Is Doing
For Its Member Companies:
Excipient GMP Assessment
Background: In 1995, IPEC-Americas, IPEC Europe, and their
member companies jointly adopted, published and implemented
for the first time, industry developed good manufacturing practice standards
for bulk pharmaceutical excipients. These were the result of a three year effort in consultation with US and European regulatory authorities and their counterparts at the World Health Organization (WHO). This later led WHO to adapt the IPEC guidance for use by its national member states and, following release of updated IPEC guidance in 2001, for the United States Pharmacopoeia to include it as a general chapter in USP/NF, e.g., <1078>.
Later, beginning in 2003, IPEC-Americas and IPEC Europe entered into an arrangement with the Pharmaceutical Quality Group, an organizational unit of the Institute of Quality Assurance, an industry association headquartered in the United Kingdom, to produce appropriate new and updated standards for the manufacturing of excipients for pharmaceutical use. This was published jointly by the three participating organizations in January 2006 and already is being widely used on a global basis. World Health Organization authorities are reviewing the guidance to update present WHO guidance and European Union regulators are considering its use as a standard to implement GMP requirements for certain excipients produced or sold in European Community countries. USP also has indicated that it intends to update its general chapter <1078> to include the new information.
Current Activities: Committees within IPEC-Americas, IPEC Europe and the Pharmaceutical Quality Group are working to produce additional guidance designed to assist in auditing and evaluating the manufacturing practices and quality systems of excipient producers. This is based on the 2006 joint IPEC/PQG GMP Guide and will be published during the first quarter of 2007.
Good Distribution Practices: This document, also a joint project of IPEC-Americas and IPEC Europe, was written to provide guidance for companies involved in the pharmaceutical excipient supply chain. It includes examples based on practical experience and reflects the ongoing concern about possible attempts to contaminate the global drug supply for purposes of terrorism. Because of this, the guide provides additional explanatory notes to the World Helath Organiztion technical report entitled "Good Trade and Distribution Practices for Pharmaceutical Starting Materials" (2003). The IPEC Good Distribution Practices Guide for Pharmaceutical Excipients was published in January 2006 and will be updated on an as needed basis to reflect any changes in global distribution practices throughout the pharmaceutical supply chain.
Other Related Guidance:
Also available through IPEC-Americas are both
a Significant Change Guide and a Certificate of Analysis Guide
for Bulk Pharmaceutical Excipients. The first is designed to
establish uniform considerations for evaluating the significance
of changes involving the manufacture of excipients and to determine
the need for informing the excipient customer and regulatory
authorities about the nature of the changes. The COA Guide standardizes
the content and format of an excipient certificate of analysis.
It also defines the roles and responsibilities of those who
produce or distribute excipients or distribute excipients for
pharmaceutical use, as well as for those who use them in the
manufacture of finished drugs. Both guides have been proposed for publication in USP/NF as general chapters and are scheduled for inclusion in USP31/NF26 which will take effect May 1, 2008.
Currently under development are guidance on
the purpose and content of a pharmacopeial monograph; excipient composition guidance, and guidance for excipient producers on what information is needed to qualify a material for use in pharmaceuticals.
Work on other future IPEC-Americas and possibly IPEC member documents also is underway. One effort concerns
specification development and the process by which an excipient
producer and his customer can agree on the specifications of a product
to be produced and purchased for a particular purpose and/or
funcion in a specific finished pharmaceutical dosage form. Representatives
of over 15 member companies are engaged in the project, which
is expected to continue throughout 2007.
One phase of the project, however, was completed in 2005. This involved publication of a Standardized Excipient Information Protocol User Guide which lays out standards for the exchange of data between an excipient supplier and companies which are considering use of a supplier's excipient in a finished drug product.
The EIP package includes a site quality overview, a product regulatory datasheet and a site and supply chain security overview. Each document is organized much like a material safety data sheet with separate sections that include specified data and which can be adapted to fit specific user needs or product characteristics.
Related complementary regulatory reference information also is available on the Regulatory Reference webpage which lists links to various regional regulatory websites.
3rd
Party Auditing: The keystone of the ongoing supplier
assessment program involves auditing the manufacturing practices
and processes of excipient suppliers and distributors. the audits
will be conducted by Labtest International, a global GMP auditing
subsidiary of Intertek Testing Services (ITS), using auditors
trained by International Pharmaceutical Excipients Auditing,
Inc. (IPEA), an IPEC-Americas subsidiary company. Auditing began
in April 2002 and has grown every year since, along with a new program which involves auditor training. For more information, please visit the IPEA website at www.ipeainc.com.
Excipient Safety Evaluation Guidance:
Safety Evaluation Guidelines developed
and originally adopted in 1995 by IPEC-Americas apply to the
primary routes of administration. Similar guidelines were published
by IPEC Europe in January 1998. Both were reviewed in 2002 and
updated.
The guidelines are presented in a tiered approach of recommended
data that should be available on an excipient to provide a pharmaceutical
formulator with a rational basis for including a new excipient
in a drug formulation and have been evaluated by U.S., European,
and Japanese regulatory agencies. In fact, much of what is in the IPEC guide is included in current FDA guidance entitled Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients.
Industry Meetings and Conferences
As the need has arisen since its founding, IPEC-Americas has continued to produce workshops and industry-wide conferences that address important regulatory affairs and compendial issues. The most recent conference celebrated the 15th Anniversary of IPEC and took place in early 2006 in Orlando Florida.
Pharmacopoeial Harmonization Projects
IPEC committees and technical working parties from the three
principal regions, e.g., the Americas, Europe, & Japan,
have developed and submitted proposed monographs for a number
of excipients identified by the major compendia as priority
candidates for harmonization. Some industry submissions have
been recommended for acceptance by one or more committees of
revision and others are under review by pharmcopoeial committees.
Currently, IPEC-Americas subcommittees are working to harmonize numerous important excipient materials that include several cellulose derivatives, gelatin, glycerin, magnesium stearate, the parabens, polyethylene
glycol, the polyols, starches and titanium dioxide. Special working groups studying heavy metals-related issues and others that involve method validation also are active.
For more information on IPEC...
...and to learn more about how your company can benefit by joining IPEC-Americas,
you are invited to contact:
info@ipecamericas.org
IPEC-AMERICAS
1655 North Fort Myer Drive, Suite 700
Arlington, VA 22209
Tel: (703) 875-2127
Fax: (703) 525-5157
last update 02/25/2008
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