坦桑尼亚药品和医疗器械管理局开展的良好生产规范检查:2018 年至 2020 年两个财政年度的比较研究。

IF 3.3 Q1 HEALTH POLICY & SERVICES Journal of Pharmaceutical Policy and Practice Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI:10.1080/20523211.2024.2399722
Raphael Zozimus Sangeda, Chimpaye Julius Ndabatinya, Maganga Bundala Maganga, Emmanuel Alphonce Nkiligi, Yonah Hebron Mwalwisi, Adam Mitangu Fimbo
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引用次数: 0

摘要

背景:药品生产质量管理规范(GMP)是制药行业质量保证的基石,可确保产品始终按照质量标准进行生产和控制。本研究以 2014 年《东非药品生产质量管理规范》(East African GMP Compendium on Good Manufacturing Practices)为基准,比较了 2018/2019 和 2019/2020 两个财政年度制药厂的 GMP 达标情况:我们分析了国外制药行业符合 GMP 标准的比例,并报告了两年期间的汇总数据:受检企业存在明显的不符合项,最常见的是与实验室质量控制和场所有关的不符合项。我们注意到,与 2018/2019 年相比,2019/2020 年的符合率呈下降趋势,只有 32.9% 的设施符合 EAC GMP 要求,低于上一年的 50%。COVID-19 大流行影响了现场检查的能力,可能是导致符合率降低的原因之一:这些发现强调了继续开展 GMP 检查的必要性,以及采取纠正措施以确保在坦桑尼亚销售的产品符合质量标准的重要性。研究进一步揭示了案头审查在协助监管当局应对大流行病等意外挑战方面的重要意义。
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Good manufacturing practice inspections conducted by Tanzania medicines and medical devices authority: a comparative study of two fiscal years from 2018 to 2020.

Background: Good Manufacturing Practices (GMP) is the bedrock of quality assurance in the pharmaceutical industry that ensures that products are consistently produced and controlled according to quality standards. This study compared the GMP conformance of pharmaceutical facilities across two fiscal years, 2018/2019 and 2019/2020, using the East African GMP Compendium on Good Manufacturing Practices, 2014, as a benchmark.

Methods: We analyzed the proportion of conformance of foreign pharmaceutical industries to GMP standards and reported the aggregated data over a two-year period.

Results: Inspected facilities had notable non-conformances, most commonly related to laboratory quality control and premises. We noted a downward trend in conformance in 2019/2020 compared with 2018/2019, with only 32.9% of facilities adhering to EAC GMP requirements, down from 50% in the previous year. The COVID-19 pandemic has affected the ability to conduct on-site inspections, and may have contributed to the lower conformance rate.

Conclusions: These findings underscore the crucial need to continue GMP inspections and the importance of taking corrective actions to ensure adherence to the quality standards for products marketed in Tanzania. The study further revealed the significance of desk reviews in assisting regulatory authorities in facing unforeseen challenges such as pandemics.

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来源期刊
Journal of Pharmaceutical Policy and Practice
Journal of Pharmaceutical Policy and Practice Health Professions-Pharmacy
CiteScore
4.70
自引率
9.50%
发文量
81
审稿时长
14 weeks
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