Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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4 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m Compliance Report Card A t the September 2019 PDA/FDA Joint Regulatory Confer- ence, speakers from FDA shared a quality mantra: "Patients expect safe and effective medicine with every 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 that the drugs they take are safe, product recalls, drug shortages, reports of potential contaminants, and publicized regulatory enforcement ac- tions can shake public confidence in the drug supply. Assuring availability and safety Limited availably of some drugs due to manufacturing problems and materials quality or shortages can impact some patient populations. FDA data (2) show the number of recalls for drugs marketed in the United States slowed slightly over the past three years. The number of ongoing recalls, however, almost doubled from 361 in 2017 to 690 in 2018, and almost doubled again to 1172 through the first 10 months of FDA's fiscal year 2019 (ending September 30). Inspections are the primary method regulatory authorities use to iden- tify manufacturing and quality problems. Between 2009–2018, FDA in- spected, on average, more than 4500 drug and biologics facilities annually. For fiscal year 2019, the number of inspections appear to be down, with only 2733 inspections reported through early August 2019. The number of inspections at domestic drug facilities has declined since 2010; from 2010–2012, an average of more than 2000 annual inspec- tions were conducted. Only 1325 inspections of US-based drug facilities were reported in 2018. The number of foreign inspections almost doubled from 541 in 2009 to 1005 in 2018; however, fewer than 600 foreign inspec- Quality Culture Drives Patient Confidence in Drug Products Rita Peters While overall industry performance is trending positive, quality failures continue to negatively impact patients and the bio/ pharma industry. WL ADIMIR1804 -

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