Good manufacturing practices (GMP) ensure that products are consistently produced and controlled according to appropriate quality standards. This study aimed to evaluate the GMP compliance of Brazilian medicine manufacturers over the past 3 years. The outcomes, deficiencies, and significance of these were collected from 485 inspections performed between 2015 and 2017. The nonconformities were arranged by sections of the GMP guidelines to demonstrate the main areas of deficiency. During the evaluation period, 61.4 % of inspected companies were classified as GMP ‘satisfactory’; 23.3 % were classified as ‘on hold’; and 15.3 % of inspections concluded that the company did not comply with GMP and resulted in an ‘unsatisfactory’ classification. At least one deficiency was found in 280 inspections (57.7 %). Critical deficiencies were found in 52 (10.7 %) inspections, major deficiencies were observed in 203 (41.9 %) inspections, and minor deficiencies were observed in 251 (51.8 %) inspections. The most common areas of deficiency were qualification and validation, documentation, and premises. The level of GMP compliance increased over the evaluation period. Updates or additional guidelines for the specific issues in which deficiencies are often identified might be useful to improve industry GMP compliance. The public disclosure of inspection outcomes and deficiencies may encourage the industry to comply with GMP and assist regulatory authorities in the maintenance of regulatory transparency. Knowledge of GMP noncompliance patterns and trends may allow the prioritization of inspections on high-risk areas and facilities, with the main goal of protecting the population from substandard medicines.

中文翻译：

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遵守巴西药品的良好生产规范

良好生产规范 (GMP) 可确保根据适当的质量标准一致地生产和控制产品。本研究旨在评估过去 3 年巴西药品制造商的 GMP 合规性。这些结果、缺陷和重要性是从 2015 年至 2017 年间进行的 485 次检查中收集的。不符合项按 GMP 指南的部分进行排列，以证明主要的缺陷领域。评估期内，61.4%的被检查企业被评为GMP“合格”；23.3% 被归类为“搁置”；15.3% 的检查得出结论认为该公司不符合 GMP 并导致“不满意”分类。在 280 次检查（57.7%）中至少发现了一处缺陷。在 52 (10. 7 %) 检查，在 203 (41.9 %) 次检查中观察到主要缺陷，在 251 (51.8 %) 次检查中观察到轻微缺陷。最常见的缺陷领域是资格和验证、文件和场所。GMP 合规水平在评估期间有所提高。针对经常发现缺陷的特定问题的更新或附加指南可能有助于提高行业 GMP 合规性。检查结果和缺陷的公开披露可能会鼓励行业遵守 GMP 并协助监管机构维护监管透明度。了解 GMP 不合规模式和趋势可能允许优先检查高风险区域和设施，其主要目标是保护人群免受不合格药品的侵害。