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Mission
Statement
To develop, implement, and promote voluntary
guidance and other programs for the world pharmaceutical industry
that are designed to ensure that excipients and related components
in finished drug products meet only the highest appropriate
standards for quality, safety, and functionality throughout
their manufacturing process;
To encourage and assist the FDA, the USP,
and other public health and compendial authorities worldwide
to adopt scientifically suitable and valid regulatory and compendial
standards for pharmaceutical excipients;
To assist, educate, and cooperate with other
pharmaceutical industry organizations and scientific bodies
working to advance public health on matters relating to the
manufacture, use, and functionality of excipients;
To continue its efforts to have IPEC-Americas
recognized as a credible and dependable source of information
about pharmaceutical excipients in the Inter-American region;
and
To help IPEC gain similar recognition as
the leading international organization that develops and recommends
appropriate and valid voluntary manufacturing and safety standards
for excipient suppliers and companies that use excipients in
finished pharmaceutical dosage forms.
IPEC-Americas works through
ICH, WHO, and both regional and national compendial and regulatory
agencies to achieve global adoption of appropriate and scientifically
valid:
-harmonized voluntary industry
Good Manufacturing Practice standards for bulk pharmaceutical
excipients;
-guidelines for qualification
& assessment of excipient suppliers, their manufacturing
practices, and products:
-harmonized pharmacopoeial
standards for quality & identity;
-safety evaluation criteria;
-industry codes for conduct;
and
-national approval procedures
for pharmaceutical excipients.
9/26/02
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