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Quality of medicines : deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections

The circulation of poor quality medicines, especially in the developing countries, is a public health concern. Compliance with good manufacturing practices (GMP) is essential to ensure the quality, efficacy, and safety of medicines. This study evaluated the outcomes of the Brazilian Health Regulator...

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Main Authors: Geyer, Andrea Renata Cornelio, Sousa, Varley Dias, Silveira, Dâmaris
Format: Artigo
Language: Inglês
Published: Plos One 2020
Subjects:
Medicamentos - qualidade
Medicamentos - fabricação
Vigilância sanitária
Online Access: https://repositorio.unb.br/handle/10482/36920
https://doi.org/10.1371/journal.pone.0202084
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spelling ir-10482-369202020-02-18T11:34:02Z Quality of medicines : deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections Geyer, Andrea Renata Cornelio Sousa, Varley Dias Silveira, Dâmaris Medicamentos - qualidade Medicamentos - fabricação Vigilância sanitária The circulation of poor quality medicines, especially in the developing countries, is a public health concern. Compliance with good manufacturing practices (GMP) is essential to ensure the quality, efficacy, and safety of medicines. This study evaluated the outcomes of the Brazilian Health Regulatory Agency's (ANVISA) international inspections of two years (2015 and 2016) and compared these to those of other regulatory authorities. The information from 255 inspection reports was analyzed, and the type and extent of deficiencies were collected. In the period evaluated, 62.75% of ANVISA-inspected companies were classified as GMP ªsatisfactory,º 24.71% were classified as having ªon demandº status, and 12.55% of inspections concluded that the company did not comply with Brazilian GMP regulations (ªunsatisfactoryº). The most common areas of deficiency were documentation (28.63%) and premises (26.27%). The pattern of deficiencies was similar to the findings of other regulatory agencies. However, ANVISA detected a more significant number of non-compliance results than other authorities, which may be caused by differences in classifications adopted by each Agency. Furthermore, manufacturers inspected by ANVISA may follow different standards and practices for products manufactured for the Brazilian market. Disclosure of main GMP deficiencies found can be useful for encouraging the industry to comply with GMP, and additional guidelines in the specific areas where deficiencies are often identified may be useful to industry to improve GMP compliance. Harmonization of GMP guidelines and inspection procedures are the key steps to avoid duplicate work, but regulatory authorities also need to work together to enforce the proper level of GMP compliance by pharmaceutical manufacturers, assuring high quality and safe medicines supply. 2020-02-18T11:25:33Z 2020-02-18T11:25:33Z 2018-08-08 Artigo GEYER, Andreia Renata Cornelio; SOUSA, Varley Dias; SILVEIRA, Dâmaris. Quality of medicines: deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections. PLoS ONE, v. 13, n. 8, e0202084. DOI: https://doi.org/10.1371/journal.pone.0202084. Disponível em: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0202084. Acesso em: 18 fev. 2018. https://repositorio.unb.br/handle/10482/36920 https://doi.org/10.1371/journal.pone.0202084 Inglês Acesso Aberto Copyright: © 2018 Geyer et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. application/pdf Plos One
institution REPOSITORIO UNB
collection REPOSITORIO UNB
language Inglês
topic Medicamentos - qualidade
Medicamentos - fabricação
Vigilância sanitária
spellingShingle Medicamentos - qualidade
Medicamentos - fabricação
Vigilância sanitária
Geyer, Andrea Renata Cornelio
Sousa, Varley Dias
Silveira, Dâmaris
Quality of medicines : deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections
description The circulation of poor quality medicines, especially in the developing countries, is a public health concern. Compliance with good manufacturing practices (GMP) is essential to ensure the quality, efficacy, and safety of medicines. This study evaluated the outcomes of the Brazilian Health Regulatory Agency's (ANVISA) international inspections of two years (2015 and 2016) and compared these to those of other regulatory authorities. The information from 255 inspection reports was analyzed, and the type and extent of deficiencies were collected. In the period evaluated, 62.75% of ANVISA-inspected companies were classified as GMP ªsatisfactory,º 24.71% were classified as having ªon demandº status, and 12.55% of inspections concluded that the company did not comply with Brazilian GMP regulations (ªunsatisfactoryº). The most common areas of deficiency were documentation (28.63%) and premises (26.27%). The pattern of deficiencies was similar to the findings of other regulatory agencies. However, ANVISA detected a more significant number of non-compliance results than other authorities, which may be caused by differences in classifications adopted by each Agency. Furthermore, manufacturers inspected by ANVISA may follow different standards and practices for products manufactured for the Brazilian market. Disclosure of main GMP deficiencies found can be useful for encouraging the industry to comply with GMP, and additional guidelines in the specific areas where deficiencies are often identified may be useful to industry to improve GMP compliance. Harmonization of GMP guidelines and inspection procedures are the key steps to avoid duplicate work, but regulatory authorities also need to work together to enforce the proper level of GMP compliance by pharmaceutical manufacturers, assuring high quality and safe medicines supply.
format Artigo
author Geyer, Andrea Renata Cornelio
Sousa, Varley Dias
Silveira, Dâmaris
author_sort Geyer, Andrea Renata Cornelio
title Quality of medicines : deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections
title_short Quality of medicines : deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections
title_full Quality of medicines : deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections
title_fullStr Quality of medicines : deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections
title_full_unstemmed Quality of medicines : deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections
title_sort quality of medicines : deficiencies found by brazilian health regulatory agency (anvisa) on good manufacturing practices international inspections
publisher Plos One
publishDate 2020
url https://repositorio.unb.br/handle/10482/36920
https://doi.org/10.1371/journal.pone.0202084
_version_ 1672205974856794112
score 13.657419

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