4 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m
Regulatory Update
B
arring a f lurry of approvals in the last few weeks of 2019,
the number of new drugs approved by FDA in 2019 will
fall significantly below the record-setting 59 approved
in 2018. As of Dec. 10, 2019, FDA had approved 41 new
molecular entities and new therapeutic biological products in 2019,
similar to the number of approvals in 2017 and 2015 (1).
The number of warning letters issued for violations of good manu-
facturing practices (GMPs) and distribution of adulterated or unap-
proved drugs increased, however, from 121 in 2018 to 137 for 2019 (as
of December 10). On a positive note, the number of warning letters
are down from 178 letters in 2016; however, nearly 70% of the letters
went to US-based firms in 2019, up from less than 50% in 2018 (2).
Warning letters not only put the offending drug company on no-
tice; these enforcement documents serve as an early alert system to
drug manufacturers by identifying commonly cited violations. This
information should prompt drug companies to examine their own
operations—and those of contract manufacturers and suppliers—for
potential problems.
In many warning letters, FDA concludes that a company's quality
systems are inadequate. While the specific infractions vary from
letter to letter, common infractions include the following:
• Poorly maintained equipment and facilities
• Inadequate maintenance and monitoring of water systems
• Insufficient cleaning validation processes
• Inadequate—or the lack of—written procedures for stability
testing, release testing, and other quality testing steps
• Inadequate controls over data and computer systems
• Failure to explain discrepancies in drug batches
• Failure to have an adequate quality control unit. VEGEFOX.COM
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STOCK.ADOBE.COM
Warning Letters Signal
Steps to Compliance
Rita Peters
Warning letters tell the tale of
missteps by drug companies
and offer a path to
compliance for quality teams
that monitor these
enforcement actions.
