Compliance with good manufacturing practices for medicines in Brazil

Geyer, Andrea Renata Cornelio; Sousa, Varley Dias; Silveira, Dâmaris

doi:10.1007/s00769-019-01395-7

Cited by 3 publications

(2 citation statements)

References 6 publications

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“…In the longer term, the infrastructure could be used to identify and track causes of adverse events and pinpoint whether the problem was due to the drug itself or an issue during production, such as contamination, mixed labels, or an inaccurate amount of the active ingredient [18]. It could also support common manufacturing problems related to documentation [19]. This would help companies document issues and engage in continuous process improvement, which would also help avoid costs associated with adverse events.…”

Section: Rationalementioning

confidence: 99%

Distributed Ledger Infrastructure to Verify Adverse Event Reporting (DeLIVER): Proposal for a Proof-of-Concept Study

et al. 2021

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Background Adverse drug event reporting is critical for ensuring patient safety; however, numbers of reports have been declining. There is a need for a more user-friendly reporting system and for a means of verifying reports that have been filed. Objective This project has 2 main objectives: (1) to identify the perceived benefits and barriers in the current reporting of adverse events by patients and health care providers and (2) to develop a distributed ledger infrastructure and user interface to collect and collate adverse event reports to create a comprehensive and interoperable database. Methods A review of the literature will be conducted to identify the strengths and limitations of the current UK adverse event reporting system (the Yellow Card System). If insufficient information is found in this review, a survey will be created to collect data from system users. The results of these investigations will be incorporated into the development of a mobile and web app for adverse event reporting. A digital infrastructure will be built using distributed ledger technology to provide a means of linking reports with existing pharmaceutical tracking systems. Results The key outputs of this project will be the development of a digital infrastructure, including a backend distributed ledger system and an app-based user interface. Conclusions This infrastructure is expected to improve the accuracy and efficiency of adverse event reporting systems by enabling the monitoring of specific medicines or medical devices over their life course while protecting patients’ personal health data. International Registered Report Identifier (IRRID) PRR1-10.2196/28616

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Section: Rationalementioning

confidence: 99%

Distributed Ledger Infrastructure to Verify Adverse Event Reporting (DeLIVER): Proposal for a Proof-of-Concept Study

et al. 2021

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“…Por se tratar de um produto para a saúde, há um controle detalhado e rígido desde a fabricação até a qualidade final desses insumos, com Inspeção Internacional dos Fabricantes do insumo farmacêutico ativo (IFA) com emissão de relatórios detalhados do ciclo de certificação das Empresas Fabricantes dos IFA a serem utilizados no País (1)(2)(3) (7). Contudo, a garantia da continuidade dos processos de melhorias nesse contexto foi a publicação do novo marco regulatório da IFA, contido nas normas RDC 362/2020 (8) -que dis-corre sobre os critérios para a Certificação de Boas Práticas de Fabricação para as plantas de IFA e institui o programa de inspeção para os fabricantes internacionais-e a Instrução Normativa IN 62/2020, que estabelece as diretrizes para qualificação de fornecedores (9).…”

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Insumos Farmacêuticos Ativos (Ifa) - Das Necessidades À Perversa Realidade Brasileira

Oliveira¹,

Silveira²

2021

Infarma

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Durante o desenvolvimento de um medicamento no País, não há, muitas vezes, qualquer preocupação inicial no que se refere a estudos prévios sobre as origens dos insumos farmacêuticos a serem utilizados na eventual produção industrial desse bem. Dessa forma, a “conta” do impacto da dependência de importação desses insumos chega na fase final de produção industrial dos medicamentos.

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Recall of substandard medicines in Brazil during the period 2010–2018

Oliveira

Machado

Tavares

et al. 2023

BMC Health Serv Res

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Background Even with all the care taken during the production process, the pharmaceutical industries are still subject to manufacturing medicines with quality deviations, generating commercialized products without the required quality and necessitating their subsequent recall from the market. The objective of this study was to evaluate the reasons that led to the recall of medicines in Brazil in the period evaluated. Methods This is a descriptive study (using document analysis), on the recall of substandard medicines registered on the website of the National Health Surveillance Agency (ANVISA), from 2010 to 2018. The variables studied were the type of medicine (reference, generic, similar, specific, biological, herbal, simplified notification, new and radiopharmaceutical), type of pharmaceutical dosage form (solid, liquid, semi-solid and parenteral preparation), and reason for recall (Good manufacturing practices, quality and quality/good manufacturing practices). Results A total of n = 3,056 recalls of substandard medicine were recorded. Similar medicines had a higher recall index (30.1%), followed by generics (21.3%), simplified notification (20.7%) and reference (12.2%). Different dosage forms had similar recalls: solids (35.2%), liquids (31.2%) and parenteral preparations (30.0%), with the exception of semi-solids (3.4%). The reasons for the highest occurrences were related to good manufacturing practices (58.4%) and quality (40.4%). Conclusion The probable cause for this high number of recalls is the fact that, even with all the quality controls and processes in accordance with good manufacturing practices, errors can occur, both human and in automated processes, thus causing the release of batches that should not have been approved. In summary, it is necessary for manufacturers to implement a robust and well structured quality system in order to avoid such deviations, and it is up to ANVISA to apply greater oversight in the post marketing of these products.

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Compliance with good manufacturing practices for medicines in Brazil

Cited by 3 publications

References 6 publications

Distributed Ledger Infrastructure to Verify Adverse Event Reporting (DeLIVER): Proposal for a Proof-of-Concept Study

Distributed Ledger Infrastructure to Verify Adverse Event Reporting (DeLIVER): Proposal for a Proof-of-Concept Study

Insumos Farmacêuticos Ativos (Ifa) - Das Necessidades À Perversa Realidade Brasileira

Recall of substandard medicines in Brazil during the period 2010–2018

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