usp.org
US Pharmacopeia
References
1. www.fda.gov/inspections-compliance-
enforcement-and-criminal-investigations/
inspection-classification-database
2. www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-
update-fda-prepares-resumption-domestic-
inspections-new-risk-assessment-system
3. www.fda.gov/news-events/congressional-
testimony/covid-19-and-beyond-oversight-fdas-
foreign-drug-manufacturing-inspection-
process-06022020
4. www.usp.org/sites/default/files/usp/document/
our-impact/covid-19/supply-chain-timeline.pdf
5. www.fda.gov/news-events/congressional-
testimony/safeguarding-pharmaceutical-
supply-chains-global-economy-10302019#:~
text=For%20all%20regulated%20drugs%2C%20
China,has%201048%20(59%20percent)
6. www.hida.org/App_Themes/Member/docs/GA/
Industry-Issues/Emergency-Pandemic/Dept-
Commerce-Study_Healthcare-Foreign-Sourcing.
pdf
7. www.pharmaceuticalonline.com/doc/measuring-
covid-s-impact-on-availability-of-drugs-and-api-
from-india-and-china-0001
8. www.fda.gov/drugs/drug-safety-and-availability/
fda-updates-hand-sanitizers-consumers-should-
not-use
9. www.fda.gov/safety/recalls-market-
withdrawals-safety-alerts/mylan-initiates-
voluntary-nationwide-recall-three-lots-
nizatidine-capsules-usp-due-detection-trace#:~:-
text=Withdrawals%2C%20%26%20Safety%20
Alerts-,Mylan%20Initiates%20Voluntary%20
Nationwide%20Recall%20of%20Three%20
Lots%20of%20Nizatidine,Solara%20Active%20
Pharma%20Sciences%20Limited
10. economictimes.indiatimes.com/news/
politics-and-nation/death-of-jammu-children-
test-confirms-syrup-was-adulterated/
articleshow/74492777.cms
11. www.usp.org/about/public-policy/
overview-of-monographs
12. www.usp.org/sites/default/files/usp/document/
our-work/global-public-health/gph-
guidance-to-regulators-paper.pdf
Although pharmaceutical manufacturers must validate
test results indicated on supplier's certificates of analysis,
USP-verified ingredients can offer manufacturers a reli-
able way to verify the ingredient quality and a means of
qualifying new ingredient suppliers. Ingredient manufac-
turers who participate in the USP Ingredient Verification
Program have undergone extensive Good Manufacturing
Practice (GMP) facility audits, quality control and man-
ufacturing (QCM) evaluation, and laboratory testing of
their ingredients for full compliance to specifications.
The program helps manufacturers ensure that proper
quality controls are in place to make the API and excipient
quality visible. The program:
• confirms a company's compliance with applicable GMP
requirements;
• verifies conformance to appropriate specifications for
identity, strength, purity, and quality;
• confirms that ingredients meet acceptable limits for im-
purities and contaminants; and
• ensures ingredient consistency from batch to batch.
To further support the public health response to the coro-
navirus, USP is helping to accelerate the work of scientists
and manufacturers developing vaccines and treatments,
supporting front-line workers impacted by shortages of
critical drugs and personal protection equipment, and
helping to build a more resilient global medicines supply
chain. For example, a new white paper provides regula-
tors in low- and middle-income countries with recommen-
dations to mitigate the impact of the pandemic, ensure
access to quality medicines, support local manufacturers'
use of quality standards, and keep patients safe [12].
John Giannone is senior director of industry programs;
Ed Wyszumiala is director of market development; Danita
Broyles is senior market development manager of verifica-
tion programs; and Joy Brown is senior marketing manager
of growth programs at USP (301 881 0666, www.usp.org).
For more information about USP's Ingredient Verification
Program (usp.org/verification), contact Danita Broyles
(danita.broyles@usp.org).
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