BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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4 BioPharm International eBook September 2019 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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