10 October 2020 Tablets & Capsules
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%
2 0 d r u g s % 2 C % 2 0 C h i n a , h a s % 2 0 1 0 4 8 % 2 0 ( 5 9 %
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
%20Alerts-,Mylan%20Initiates%20Voluntary%20
Nationwide%20Recall%20of%20Three%20Lots%20
of%20Nizatidine,Solara%20Active%20Pharma%20
Sciences%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
John Giannone is senior director of industry programs; Ed
Wyszumiala is director of market development; Danita
Broyles is senior market development manager of verification
programs; and Joy Brown is senior marketing manager of
growth programs at USP (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's Ingredient Verification
Program, contact Danita Broyles (danita.broyles@usp.org).
The United States Pharmacopeia—National Formulary
(USP-NF) is a comprehensive source for medicine quality
standards including more than 5,000 quality standards for
chemical and biologic medicines, APIs, and excipients
(inactive ingredients) [11]. The standards in USP-NF are
used to help ensure the quality of medicines and their
ingredients and to protect the safety of patients.
In fact, USP is an official quality standard for medi-
cines marketed in the US and is used in over 140 coun-
tries worldwide and integrated into the laws of more
than 40 countries. USP-NF includes three types of quality
standards for medicines and dietary supplements: mono-
graphs, general chapters, and material reference stan-
dards. Material reference standards are used in conjunc-
tion with monographs and general chapters to verify that
a medicine and its ingredients can pass tests to ensure
adherence to quality requirements.
USP is committed during these extraordinary times to
supporting manufacturers by providing auditing and test-
ing services to verify ingredient quality through the USP
Ingredient Verification Program. USP recognizes that the
increased demand for certain ingredients might require
manufacturers to source ingredients from new suppliers.
Although pharmaceutical manufacturers must validate
test results indicated on suppliers' 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 excipi-
ent 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
impurities and contaminants; and
• ensures ingredient consistency from batch to batch.
To further support the public health response to the
coronavirus, 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 regulators in low- and middle-income coun-
tries with recommendations to mitigate the impact of
the pandemic, ensure access to quality medicines, sup-
port local manufacturers' use of quality standards, and
keep patients safe [12]. T&C
