44 October 2018 Tablets & Capsules
Expectations after
commercialization
After a regulatory agency approves
a drug product, it's incumbent on the
e x c i p i e n t m a n u f a c t u r e r t o b e
extremely proactive in managing its
relationship with the customer. Drug
product manufacturers with robust
quality systems will monitor a variety
of factors. For instance, they will
track out-of-specification results,
non-conformances, and/or validation
issues that could potentially be asso-
ciated with the quality of the pur-
chased excipient. They will also mon-
itor the supply-chain performance,
reliability, and certification status of
their suppliers. If the drug product
manufacturer is distributing products
in the European Union, they will reg-
ularly update their suppliers' risk pro-
files to ensure that the suppliers con-
tinue to meet appropriate GMPs.
The supplier-customer
relationship
Pharmaceutical companies are risk
averse and highly quality-minded.
Excipient suppliers that pay atten-
tion to the consistency of the excipi-
ents they manufacture and, through
GMP certification, demonstrate that
they consistently meet a recognized
GMP standard, will undoubtedly
set themselves up for long lasting,
win-win relationships with their
pharmaceutical customers. T&C
References
1 . h t t p : / / i p e c - e u r o p e . o r g /
U P L O A D S / I P E C _ P Q G _ G M P _
Guide_2006(1).pdf.
2. https://www.excipact.org/files/
E X C i P A C T / D o w n l o a d s / 2 0 1 8
0123%20EXC%20Standard_Final-
webversion.pdf.
3. Available at: https://webstore.
ansi.org/RecordDetail.aspx?sku=NS
F%2FIPEC%2FANSI%20363-2016
&source=blog.
Jim Morris is executive director, pharma
biotech consulting, at NSF Health Sci-
ences, a division of NSF International
(734 769 8010, www.nsf.org). A version
of this article originally appeared in T&C's
Solid Dose Digest on July 9, 2018.
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