Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 5 tions had been conducted through the first 10 months of FDA's fiscal year 2019. Meanwhile, the number of FDA inspections at do- mestic and foreign biologics facilities has held steady for the past 10 years, and these biologics facilities out- performed drug facilities in inspection results. More than 80% of inspections at biologics facilities resulted in no action indicated (NAI) classification; less than 1% of facilities inspected were classified as official ac- tion indicated. For drug facilities, only 47% received an NAI classification; a similar number received a voluntary action indicated (VAI) classification. Overall, US-based facilities manufacturing drugs and biologics performed better than foreign facili- ties. Two-thirds of US facilities received a NAI clas- sification compared with 42% of foreign facilities. More than half of the foreign facilities received a VAI classification; more than 5% were cited for of- ficial action indicated. New inspections and protocols Recognizing the need to standardize its inspection data collection and analysis, FDA announced a New Inspection Protocol Project (NIPP), that uses stan- dardized electronic inspection protocols to report on surveillance and pre-approval inspections (3). Sterile drug products were selected for the first NIPP due to ongoing quality issues with the manu- facture of this drug type that have resulted in drug shortages. The agency conducted pilot studies and incorporated feedback to develop protocols to cover critical areas of sterile drug manufacturing and pro- vide data to quickly support quality decisions. A quality culture When a drug company is cited for a quality viola- tion, the blame often is directed to the quality team or offending manufacturing unit. A quality culture should be adopted throughout an organization, said Patrizia Cavazzoni, deputy director of operations at FDA's Center for Drug Evaluation and Research at the PDA/FDA conference. Executive management is ultimately responsible for assuring reliable manufacturing operations and high-quality standards. Inspections reveal a "notable difference: when top management embraces quality," Cavazzoni said. Organizations should plan for and design quality into all systems, invest in manufactur- ing technologies, guard against decay in operational effectiveness, and ensure suppliers are aligned with your quality practices, she recommended. References 1. 2019 PDA/FDA Joint Regulatory Conference, Sept. 16, 2019, Washington, DC. 2. FDA, Data Dashboard, index.htm, accessed Sept. 19, 2019. 3. FDA, "Statement from FDA Commissioner Scott Gottlieb, M.D., on New Steps to Strengthen and Modernize Agency's Oversight and Reporting of Inspections for Sterile Injectable Drugs,", Nov. 9, 2018. PT Understanding—and keeping informed—about the many regulations, compendial requirements, and guidelines present challenges for bio/pharmaceutical companies. In this premiere issue of the Pharmaceutical Technology Regulatory Sourcebook, the editors present recent regulatory trends and enforcement actions, risk-based studies for analytical procedure validation, and insight on filing generic-drug applications. A focus of this ebook is the first installment of a comprehensive series on compendial compliance including a detailed analysis of the impact of pharmacopoeia requirements, challenges with compliance, and why harmonization is needed. The ebook also includes links to pertinent guidance documents, contact information for global regulatory authorities, and other tools to aid in compliance. About this eBook

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