14 October 2019 Tablets & Capsules
tation review evaluates the quality of the excipient and
the manufacturing process from start to finish, providing
drug product manufacturers with a more standardized
means of qualifying their suppliers on an annual basis. It
is important to note that, according to FDA regulatory
requirements, regardless of whatever supplier validation
program is in place, drug manufacturers are still required
to conduct at least one test to verify the identity of each
component of a drug product, including excipients.
Although drug manufacturers can use USP's resources
to help with excipient supply and testing issues, it is ulti-
mately the responsibility of all drug manufacturers to
confirm that their products comply with appropriate
cGMP requirements to safeguard patient health. T&C
References
1. w w w.fda.gov/dr ugs/news-events-human-dr ugs/
cder-conversation-assuring-drug-quality-around-globe.
2. w w w.fd a.gov/reg ulator y-infor mation /sear ch-
fda-guidance-documents/testing-glycerin-diethylene-
glycol.
3. www.fda.gov/media/86193/download.
John Giannone is senior director, strategic marketing and
program operations (SMPO) for excipients; Michael Rashed
is marketing director, SMPO, for excipients; Peter Claise is
marketing director, foods and excipients programs, SMPO;
and Doug Podolsky is a technical writer at USP (301 881
0666, www.usp.org). USP is a private, independent, non-
profit organization founded in 1820 that develops scientific
standards to help ensure the quality and safety of medicines,
dietary supplements, and foods.
For more information about USP IVP-E, contact John Atwater
(301 816 8529, jba@usp.org).
For more information about USP's proposed general chapter
on supplier qualification, contact Catherine Sheehan (301
816 8262, cxs@usp.org).
Acid Resistant Vegetable Capsules
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AN EXCELLENT CHOICE FOR
DELIVERY OF ACID-SENSITIVE
ACTIVE INGREDIENTS
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BioCaps Enterprises, Inc.
www.biocaps.net • info@biocaps.net
US Patent 9452141
SSW Booth# 2153