Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study

Boltić, Zorana; Ruzic, Nenad; Jovanović, Mića; Petrović, Slobodan

doi:10.1007/s00769-010-0709-2

Cited by 8 publications

(5 citation statements)

References 10 publications

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“…Further, QTHA and QTHC are found to have a significant and positive impact on hazard controlling. These results are also consistent with Boltic et al (2010), Kaynak (2003) and Varu and Khanna (2010).…”

Section: Discussionsupporting

confidence: 90%

“…In the current literature, several quality tools have been introduced such as lean manufacturing (Melton, 2005), Six Sigma (Andersson et al , 2009), 5s (Moriones et al , 2010), Kaizen (Singh and Dhalla, 2010), Pareto analysis (Boltic et al , 2010), quality by design (QbD) (Sangshetti et al , 2014) to support the standard operating procedure (SOP), employee hygiene, design procedure, apparatus maintenance and supplier selections in food and pharmaceutical industries. However, the existing literature does not study on the application of quality tools for the HACCP-based food safety system.…”

Section: Introductionmentioning

confidence: 99%

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The application of quality tools in effective implementation of HACCP

Kharub¹,

Limon

Sharma

2018

IJQRM

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Purpose The purpose of this paper is to empirically investigate the quality tool’s impact on the effectiveness of the Hazard Analysis and Critical Control Point (HACCP)-based food safety system and correlation studies between HACCP effectiveness and business performance in food and pharmaceutical industries. Design/methodology/approach A total of 116 survey responses of prominent food and pharmaceutical firms are used to fulfil the aim of this study. The principal component analysis (PCA) method was applied to classify quality tools into a finite number of groups. Further, multiple regression methods are employed to investigate the correlation between HACCP effectiveness and firm’s performance indicators. Findings Quality tools are classified into three categories on the basis of their application by using the PCA method: quality tools for hazard identification, quality tools for hazard analysis (QTHA) and quality tools for hazard control. The regression analysis revealed that QTHA has a substantial impact on HACCP objectives (hazard identification, hazard assessment and hazard control). Additionally, the results suggest that the successful implementation of HACCP-based food safety system also delivers a direct influence on the operational and financial performance of the food and pharmaceutical industries. Originality/value This paper contributes to the existing body of HACCP knowledge by providing a framework supported by an empirical case study. The case study clustered quality tools into three broad categories related to their application of a HACCP project. Study results can guide and motivate managers to use quality tools with the aim of successful implantation of the HACCP-based food safety system, especially in food and pharmaceutical industries.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

The application of quality tools in effective implementation of HACCP

Kharub¹,

Limon

Sharma

2018

IJQRM

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“…The adoption of a QMS in radiopharmaceutical production is even more important since M the short life of radiopharmaceuticals used for PET does not permit sterile quality control before injection [7,9]. Moreover, measurement of the performance of the production process, in terms of deviations, out of specification (OOS) and other quality and performance indicators [10], benefits from the application of a QMS. ISO 9001:2008 is focused on aspects related to the continuous improvement of the QMS [11].…”

Section: Introductionmentioning

confidence: 99%

Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre

et al. 2012

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The production of pharmaceuticals is one of the most highly regulated fields in terms of quality. The body of good manufacturing practice (GMP) represents the standard required by law; GMP embraces the guidelines that regulate all activities related to the production and quality control of medicinal products for human and veterinary use. This paper deals with the implementation of a quality management system (QMS) in compliance with GMP and ISO 9001 standards for the production and distribution of radiopharmaceuticals in a public research institute. The production of 2-[18F]fluoro-2-deoxy-D-glucose has been implemented according to GMP standards and has been licensed by the national Authority in 2007. In 2010, a project to orient the system's GMP compliance to ISO 9001 standards has been approved. A QMS conforming to ISO 9001:2008 should be considered an important additional step in terms of quality, because ISO 9001 also takes into account economic and financial aspects, design and development aspects and introduces management review for measurement and analysis of the process with the aim of improving performances. The harmonization between GMP and ISO has been defined following the Pharmaceutical Quality System Q10 guideline developed by International Conference on Harmonization.

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“…Mesmo com uma equipe capacitada e controles durante os processos, desvios ainda assim podem ocorrer, e os responsáveis pela sua investigação devem ser pessoas treinadas e capacitadas (4,5).…”

Section: Introductionunclassified

Aplicação De Ferramentas Da Qualidade Em Um Desvio De Qualidade Na Indústria Farmacêutica: Um Estudo De Caso

Amorim

Garcia-Amoedo

2021

Infarma

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Atualmente, devido à grande concorrência entre as indústrias, houve um aumento de demanda por produtos mais eficientes, seguros e com excelência em qualidade, gerando a necessidade de processos mais robustos e equipe qualificada e capacitada. Entretanto, desvios de qualidade podem ocorrer durante o processo produtivo, e as causas destes eventos devem ser identifi cadas e solucionadas, a fim de evitar repetições dos erros. O objetivo deste trabalho foi demonstrar por meio de um estudo de caso, a utilização prática das ferramentas da qualidade para identificar e solucionar um desvio de qualidade de comprimidos quebrados em uma indústria farmacêutica. Para identificação da causa raiz do desvio, organização e interpretação dos dados, foram utilizadas ferramentas da qualidade, tais como Diagrama de Pareto, Gráfico de Controle, Folha de Verifi cação e Diagrama de Ishikawa. Após a avaliação dos dados por meio destas ferramentas, foi possível concluir que a quebra dos comprimidos está relacionada com o resultado baixo do teste de dureza, e, portanto, foi sugerido à empresa fabricar os próximos lotes buscando a dureza próxima ou superior a 200 N, conforme histórico do produto. Sendo assim, as ferramentas da qualidade se mostraram essenciais para uma avaliação efetiva do desvio de qualidade.

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Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study

Cited by 8 publications

References 10 publications

The application of quality tools in effective implementation of HACCP

The application of quality tools in effective implementation of HACCP

Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre

Aplicação De Ferramentas Da Qualidade Em Um Desvio De Qualidade Na Indústria Farmacêutica: Um Estudo De Caso

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