David R. Schoneker
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The International Pharmaceutical Excipients Council (IPEC) Federation was officially formed earlier this year to coordinate
IPEC's global activities in the areas of compendial harmonization, excipient guidelines and standards development, and coordination
of excipient supply-chain security initiatives with regulatory agencies around the world. The Federation's current membership
is made up of IPEC–Americas, IPEC–Europe, IPEC–Japan, and IPEC–China.
IPEC–Americas has also expanded its reach in Latin America through two partnerships. The new relationships will allow the
growing pharmaceutical and excipient industries in that region to participate in IPEC activities and to use IPEC guidelines
to improve quality and protect patients.
Brazil
In 2009, IPEC–Americas signed a formal partnership agreement with Sindusfarma in Saõ Paulo, Brazil. Sindusfarma is a key pharmaceutical
trade association known for publishing various quality and good manufacturing practice (GMP) guidelines for the pharmaceutical
industry. The guides are heavily used in the Brazilian pharmaceutical manufacturing sector. However, Sindusfarma has not published
any guidelines specifically related to excipients and wanted to help the domestic market gain a better understanding of the
types of excipient-control strategies being used in the global market.
As a result of the partnership with IPEC, Sindusfarma now has access to IPEC guidelines such as those on excipient qualification
and good distribution practice, and is translating them into Portugese for distribution to the Brazilian regulatory agency,
ANVISA, and the local pharmaceutical industry.
IPEC Foundation awards research and innovation
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As part of the partnership launch, IPEC–Americas and Sindusfarma cosponsored an Excipient Control Strategies Conference in
Saõ Paulo this past August. The event brought together experts and local representatives from IPEC–Americas, the International
Pharmaceutical Excipient Auditing (IPEA) organization, and the Brazilian Pharmacopeia, as well as pharmaceutical and excipient
manufacturers and excipient distributors to discuss how the use of harmonized guidelines could affect patient safety and the
industry in Brazil. Perspectives from the manufacturing and excipient side were provided and discussed. Sessions also addressed
third-party audits and the Brazilian Pharmacopeia's plans for handling excipients.
Argentina
IPEC–Americas also entered a partnership agreement with a pharmaceutical professional association in Buenos Aires, Argentina,
called Safybi, this past August. Safybi's membership includes pharmacists and pharmaceutical scientists from around the country.
The association runs training sessions for the local industry on topics such as GMPs, quality, and formulation science.
As part of the partnership signing ceremony, Safybi hosted an excipient control seminar for their members covering many GMP,
quality, and quality-by-design topics. Safybi is now translating the IPEC–PQG Excipient GMP and IPEC good distribution practice
guidelines into Spanish. Once completed, these guidelines will be distributed to the industry in Argentina and Safybi will
begin work on translating other guidelines.
Looking ahead, IPEC–Americas intends to work with its new partners to to coordinate an annual conference in each country
on excipient issues. The organization is also working to set up an IPEC–India in early 2011.
David R. Schoneker is a past chair of IPEC–Americas and director of Global Regulatory Affairs for Colorcon, DSchoneker@colorcon.com
