4 BioPharm International eBook September 2019 www.biopharminternational.com
Regulatory Sourcebook Compliance Report Card
A
t the September 2019 PDA/FDA Joint
Regulatory Conference, speakers from
FDA shared a quality mantra: "Patients
expect safe and effective medicine with
ever y dose they take." The speakers
broadly defined pharmaceutical quality as "assuring
every dose is safe and effective, free of contamination
and defects," and this quality paradigm is "what gives
patients confidence in their next dose of medicine" (1).
While patients generally trust the drugs they take
are safe, recalls, drug shortages, reports of potential
contaminants, and regulatory enforcement actions
can shake public confidence in the drug supply.
Building and maintaining a quality system for drug
substances and drug products across a global supply
chain presents challenge for all drug companies.
ASSURING DRUG AVAILABILITY AND SAFETY
The limited availability of some drugs due to manufac-
turing problems, quality issues, or materials shortages
has historically impacted some patient populations.
FDA data (2) show the number of recalls for drugs mar-
keted in the United States slowed slightly over the
past three years. The number of ongoing recalls, how-
ever, almost doubled from 361 in 2017 to 690 in 2018,
and almost doubled again to 1172 through the first 10
RITA PETERS
While overall industry performance is trending positive,
quality failures continue to negatively impact
patients and the bio/pharma industry.
Quality Culture Drives Patient
Confidence in Drug Products
EtiAmmos
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