Benefits
of IPEC-Americas Membership
- Access
to globally accepted industry guidance documents covering:
- international
good manufacturing practice principles for pharmaceutical
excipients;
- GMP
auditing of excipient suppliers and distributors;
- format
and use of excipient certificates of analysis;
- identification
and reporting of significant changes which occur during
an excipient's manufacture;
- standardized excipient information to help suppliers and users better evaluate excipients for pharmaceutical use;
- submission and maintainence of data for Type IV excipient drug master files;
- excipient
composition; and
- essential elements of the excipient qualification and specification development processes.
- Access
to audit reports of excipient supplier and distributors' practices
generated by the IPEC-Americas 3rd party GMP auditing program that is managed and administered by its subsidiary company, International Pharmaceutical Excipients Auditing, Inc. (IPEA)
- Opportunity
to have member company auditors trained to conduct
excipient supplier and distributor audits based on the Joint IPEC/PQG
GMP Guide for Pharmaceutical Excipients and companion
Audit Guidelines
- Access
to and ability to influence USP, PhEur and JP decisions and directives by service on compendial
working groups and expert committees
- Access
to FDA, USP, and other industry organizations through involvement
with CHPA, Product Quality Research Institute (PQRI) and ASTM International projects and
committee service
- Opportunity
to work with FDA to improve the content and format of the
agency's inactive ingredient guide and its Type IV drug masterfile
system
- Access
to FDA, USP, ICH, European Union and WHO directives, guidance,
programs, and meetings though member notices, bulletins and
newsletters.
- Access
to the members-only sections of the IPEC-Americas website
to comment on IPEC draft monographs, position papers and policy
statements; to register for meetings; and to purchase IPEC
publications at discount prices
- Gain
discounts on IPEC seminars and conferences
and
much more.......
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
Mailing Address:
IPEC-AMERICAS
1655 North Fort Myer Drive, Suite 700
Arlington, VA 22209
Tel: (703) 875-2127
Fax: (703) 525-5157
updated: 5/2/08
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