Conformity Decisions Based on Measurement Uncertainty—a Case Study Applied to Agar Diffusion Microbiological Assay

Separovic, Luciana; Bertanha, Maria Luiza de Godoy; Saviano, Alessandro Morais; Lourenço, Felipe Rebello

doi:10.1007/s12247-019-09374-8

Cited by 7 publications

(6 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…It is also possible to assess the risks of multi-component models, where several factors can affect the quality of the product [36,37]. Examples include risk assessment in food quality control [38], drug quality control [39,40], air quality control [41], the chromatography process [42], pharmaceutical equivalence studies when comparing generic and reference drugs [43], and other related areas.…”

Section: Introductionmentioning

confidence: 99%

Risk Assessment for Linear Regression Models in Metrology

Božić,

Runje,

Razumić

2024

Applied Sciences

View full text Add to dashboard Cite

The conformity assessment of products or a measured value with the given standards is carried out based on the global risk of producers and consumers’ calculations. A product may conform to specifications but be falsely rejected as non-conforming. This is about the producer’s risk. If a product does not meet the requirements but is falsely accepted as conforming, that poses a risk to the consumer. The conventional approach to risk assessment, which yields only a single numerical value for the global risk of producers and consumers, is naturally extended and utilized for assessing risk in measurement models with linear regression. The outcomes of the two-dimensional extension, along a moderate scale, are the parabolas with upwards openings. Risk surfaces were obtained through three-dimensional extension over the area limited by the moderate scale and guard band axes. Four models with different ranges of tolerance intervals were used to test this innovative method of risk assessment in linear regression. The corresponding standard measurement uncertainties were determined by applying a simplified measurement model with the use of comprehensive data on the measurement performance and by determining measurement uncertainty derived from consideration of the functional relationship obtained by linear regression analysis. Models that utilize information from linear regression analysis to determine measurement uncertainty are biased towards risks at the edges of the moderate scale. Testing the model’s performances with metrics related to the confusion matrix, such as the F1 score, further substantiated this assertion. The diagnostic odds ratio has been proven to be extremely effective in identifying the curve along the guard band axis, along which the global risks of producers and consumers are at their lowest.

show abstract

Section: Introductionmentioning

confidence: 99%

Risk Assessment for Linear Regression Models in Metrology

Božić,

Runje,

Razumić

2024

Applied Sciences

View full text Add to dashboard Cite

show abstract

“…Os riscos globais e condicionais são aqueles representativos de um item ou lote ainda não testado, diferindo pelos riscos condicionais considerarem em sua estimativa o resultado futuro ser dado como "aprovado" ou "reprovado" 119 . Já os riscos específicos são considerados para um valor de resultado analítico de um item ou lote testado 120 .…”

Section: Introductionunclassified

“…Os riscos específicos também podem ser estimados pela abordagem frequentista, que é baseada apenas no valor do resultado analítico, incerteza de medição e faixa de especificação, sendo uma abordagem útil para laboratórios prestadores de serviço ou de vigilância, não havendo necessidade de conhecimento prévio do processo produtivo 120 .…”

Section: Introductionunclassified

See 1 more Smart Citation

Incerteza de medição na avaliação de desempenho de métodos analíticos e estratégias de melhoria com a aplicação do Analytical Quality by Design

Separovic¹

Self Cite

View full text Add to dashboard Cite

À minha melhor amiga Talita, por estar presente nos momentos bons e ruins, pela amizade, companheirismo, apoio e por sempre torcer e acreditar em mim.À minha quase irmã Paula, por toda amizade, colaboração e apoio não somente ao longo da realização deste trabalho, mas na vida.Aos meus amigos e familiares, pela amizade, por toda ajuda e por acreditarem em mim.Ao meu orientador, Prof. Dr. Felipe, por todo ensinamento, atenção e por acreditar em meu potencial e sempre apoiar meu progresso. À Claudineia, Edgar, Elisabete e Rogério, pelos ensinamentos e assistência na realização prática deste trabalho. Ao Prof. Dr. André, por ser o primeiro a sugerir a mudança de nível do meu projeto, acreditando em seu potencial. Ao Prof. Dr. Ricardo da Universidade de Lisboa, pelas oportunidades de colaboração, ensinamentos e credibilidade. Ao secretário do programa, David, por toda assistência ao longo desses anos. À CAPES, pois o presente trabalho foi realizado com apoio da Coordenação de Aperfeiçoamento de Pessoal de Nível Superior -Brasil (CAPES) -Código de Financiamento 001. À Fapesp, pelo apoio financeiro concedido através do processo no 2018/25734-0, Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP). Finalmente, à Faculdade de Ciências Farmacêuticas, em especial ao Departamento de Farmácia, pela oportunidade de realização deste trabalho! "Somente a dose correta diferencia o veneno do remédio." Paracelso (1493-1541) RESUMO SEPAROVIC, L. Incerteza de medição na avaliação de desempenho de métodos analíticos e estratégias de melhoria com a aplicação do Analytical Quality by Design. 2021. 104p. Tese (Doutorado) -Faculdade de Ciências Farmacêuticas,

show abstract

“…Quando a medida apresenta distribuição aproximadamente lognormal, um fator de incerteza multiplicativa pode ser uma escolha melhor para obter um intervalo assimétrico em torno da medida (RAMSEY; ELLISON, , 2017. A incerteza de medição fornece informações que permitem estimar o risco de decisões falsas quanto a avaliação de conformidade, sobre a aceitação de um lote com contaminação acima do limite (risco dos consumidores) ou rejeição de um lote com contaminação abaixo do limite (risco dos produtores) (SEPAROVIC et al, 2020;MAGNUSSON, 2021).…”

unclassified

Incerteza de medição associada à contagem microbiana de produtos farmacêuticos

Dias¹

View full text Add to dashboard Cite

Microbial contamination can compromise the efficacy and safety of pharmaceutical products.Microbial counting tests are used to assess the microbiological quality of non-sterile pharmaceutical products required by most pharmacopoeia compendiums. Despite this, measurement uncertainty assessment for microbial count tests is rarely considered, which can lead to false compliance/non-compliance decisions. In this work we evaluated the matrix effects on microbial counting tests and their top-down uncertainty assessment, and evaluated measurement uncertainty using the bottom-up approach, inaddition to estimating the consumer's or producer's risks due to measurement uncertainty. The combined and expanded uncertainties calculated using the top-down approach considered accuracy (recovery) and accuracy as the main components of uncertainty. The uncertainty component of accuracy was the most relevant in 59% of the samples studied, while accuracy was the main source of uncertainty in only 41% of the samples, being observed that the greater the interference of the matrix, the greater the uncertainty factor and, consequently, the greater the asymmetry for the interval around the measurement. From the bottom-up approach, three main sources of uncertainty were identified and quantified: dilution factor, platelet volume and plaque count. The contribution of these sources of uncertainty depends on the measured value of microbial load in pharmaceutical products, the contribution of the dilution factor and uncertainties of the plated volume increase with the increase in the measured value, while the contribution of plate counting decreases with the increase of the measured value.It was possible to assess the risk of false decisions due to measurement uncertainty by estimating consumer or producer risks. The risks were evaluated using the Monte Carlo method. Therefore, the relevance of measuring uncertainty assessment has been demonstrated to ensure the reliability of microbial count test results and to support decision-making when assessing non-sterile pharmaceutical conformity/non-compliance.

show abstract

Conformity Decisions Based on Measurement Uncertainty—a Case Study Applied to Agar Diffusion Microbiological Assay

Cited by 7 publications

References 19 publications

Risk Assessment for Linear Regression Models in Metrology

Risk Assessment for Linear Regression Models in Metrology

Incerteza de medição na avaliação de desempenho de métodos analíticos e estratégias de melhoria com a aplicação do Analytical Quality by Design

Incerteza de medição associada à contagem microbiana de produtos farmacêuticos

Contact Info

Product

Resources

About