دورية أكاديمية
A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023.
| العنوان: | A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023. |
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| المؤلفون: | Patel R; Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar, India. Electronic address: ap_ravi_patel@gtu.edu.in., Vhora A; Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar, India., Jain D; Department of Regulatory Affairs, Senores Pharmaceuticals Ltd., Ahmedabad, India., Patel R; Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India., Khunt D; Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar, India., Patel R; Jamp Pharmaceuticals Pvt Ltd, Ahmedabad, Gujarat, India., Dyawanapelly S; Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai, India. Electronic address: sa.dyawanapelly@ictmumbai.edu.in., Junnuthula V; Drug Research Program, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland. Electronic address: jvbreddy@outlook.com. |
| المصدر: | Drug discovery today [Drug Discov Today] 2024 Jun; Vol. 29 (6), pp. 103993. Date of Electronic Publication: 2024 Apr 25. |
| نوع المنشور: | Journal Article; Review |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Ltd. Country of Publication: England NLM ID: 9604391 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-5832 (Electronic) Linking ISSN: 13596446 NLM ISO Abbreviation: Drug Discov Today Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Kidlington, Oxford : Irvington, NJ : Elsevier Science Ltd. ; Distributed by Virgin Mailing and Distribution, c1996- |
| مواضيع طبية MeSH: | United States Food and Drug Administration* , Drug Industry*/standards, United States ; Drug Recalls ; Humans ; Retrospective Studies |
| مستخلص: | To introduce products in the US market, pharmaceutical companies must first obtain FDA clearance. Manufacturers might recall a product if it poses a risk of damage or violates FDA regulations. This study investigates the types, causes and consequences of recalls, as well as FDA participation and suitable recall strategies. We relied on the FDA website to gather recall data sets from 2012 to 2023, collecting information on the date of issuance, company and type of violation. The most frequent causes for recalls were sterility issues and inadequate compliance with current good manufacturing practices (cGMP). An examination of sterility recalls revealed two primary causes: a lack of assurance in sterility (accounting for 48% of recalls) and instances of non-sterility (making up 45% of recalls). A thorough examination of cGMP recalls revealed five primary types of violations: process control issues, inadequate storage practices, manufacturing problems, the presence of nitroso-amine impurities and concerns regarding stability. The findings demonstrate that sterility and cGMP compliance are FDA priorities. Pharmaceutical companies must, therefore, enhance quality compliance and create effective quality management systems that oversee the manufacturing process, quality control, personnel training and documentation to avoid these recalls. Companies should establish an internal compliance checklist and be prepared for the rectification process. (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.) |
| فهرسة مساهمة: | Keywords: FDA regulations; cGMP; contamination; drug recalls; drug safety; sterility |
| تواريخ الأحداث: | Date Created: 20240426 Date Completed: 20240526 Latest Revision: 20240526 |
| رمز التحديث: | 20240527 |
| DOI: | 10.1016/j.drudis.2024.103993 |
| PMID: | 38670257 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1878-5832 |
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| DOI: | 10.1016/j.drudis.2024.103993 |