The Utilization of Quality KPIs in the Pharmaceutical Industry

Torkko, Marianne; Katajavuori, Nina; Linna, Anu; Juppo, Anne

doi:10.1007/s12247-014-9184-3

Cited by 8 publications

(11 citation statements)

References 10 publications

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“…According to Leckie (2005), working within a high-performance, target-driven and time-constrained "Right First Time" (RFT) working environment may have a particular contextual impact upon the urgent nature of information triggers. In relation to the context of this study, Torkko et al (2014) support that "Price pressure and stiff competition are driving the pharmaceutical industry towards greater efficiencies, higher quality, and continuous improvement". It is not only important to perform procedures "right the first time (RFT)" but also without delays and additional costs, associated with errors or losses (p. 175).…”

Section: Information Needs' Triggersmentioning

confidence: 55%

“…These include, for example, “ Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 ” published by the Medicine and Healthcare Regulatory Agency (MHRA) in the UK, which is known in the industry as the “Orange Guide” (MHRA, 2017); the Irish Health Product Regulatory Authority (HPRA, 2014) and the US 21 Federal Code of Regulation Parts 210 and 211 and Guidance documents (FDA, 2017). In addition, pharmaceutical production work is conducted within an information rich environment, where strategic goals of quality products, creativity, continuous improvement, greater efficiencies and a drive for “right the first time (RFT) without a time delay” (Torkko et al. , 2014, p. 175) are of paramount importance.…”

Section: Introductionmentioning

confidence: 99%

“…Within a manufacturing context, pharmaceutical information can include (but is not limited to) multi-jurisdictional regulations and international standards and guidelines, corporate and in-house procedures and guidelines, manufacturing plant commissioning/qualification documentations, production records and documentation pertaining to quality/compliance/regulatory support services. In addition to handling vast amounts of information, those working within the pharmaceutical production sector are operating within a high-performance working environment, where efficient use of time is imperative (Torkko et al. , 2014) and where enhanced information-seeking abilities and information systems are beneficial (Bawden and Robinson, 2011, p. 24).…”

Section: Introductionmentioning

confidence: 99%

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An investigation into the information-seeking behaviour of professionals, working within the pharmaceutical manufacturing sector in Ireland

Browne

Μαρτζούκου

2022

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PurposeThis research aimed to investigate the information-seeking behaviour (ISB) and information needs of different professional groups within the pharmaceutical manufacturing sector in the Republic of Ireland (i.e. for what purpose information is acquired), the information sources professional groups use (including in-house documentation, regulations, industry guidelines, standards and colleagues) and the factors, which influence professional groups' choice of information sources. Furthermore, the research explored the perceived level of support that exists towards knowledge and information sharing.Design/methodology/approachA quantitative non-experimental research design, comprising of a self-completion survey questionnaire, was used to examine a number of information-seeking variables: information triggers, information sources and source influencers as well as information sharing enablers. It was related to four professional tasks: process technology/process development, regulatory support and quality/compliance support and engineering.FindingsThe research provides new insights into the ISB of pharmaceutical professionals working within a highly regulated and high-performance production environment, including a greater understanding of the context in which professional groups experience information needs. The levels of agreement observed in relation to employees' perception of information-sharing enablers indicated an overall positive level of information sharing.Research limitations/implicationsThe study points to largely echoed previous findings which suggest that individual work role associated tasks prompt particular information needs. Further to this, work role associated tasks have a bearing on information source selection. Pharmaceutical professionals engaged in positive levels of information and knowledge sharing, relying on procedures, other colleagues and internal documentation as information sources. The participants also indicated a high level of agreement in respect to the value of available subject matter experts as information-sharing enablers.Practical implicationsOrganisations should aim to create opportunities for adequate time to share information and organisational structures, facilitating an overall organisational culture of sharing. A focus on information sharing through forums, seminars, meetings and working groups could enhance information sharing, through the development of communities of practice.Social implicationsPharmaceutical professionals relied on trustworthiness and quality as professional' top information source-influencing factors. Furthermore, the study demonstrated that working within a high-performance, target-driven and time-constrained production environment brings a particular contextual impact, where frequent urgent information triggers are experienced. These contextual factors warrant further investigation.Originality/valueA paucity of information exists with respect to the ISB of professionals, working within the pharmaceutical manufacturing sector, which is a sector known for its high level of information use and production. This paper offered an original empirical investigation of the ISB of professionals, working within the pharmaceutical manufacturing sector in the Republic of Ireland, focussing on key professional tasks. The research also addressed the level of support available for knowledge and information sharing.

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Section: Information Needs' Triggersmentioning

confidence: 55%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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An investigation into the information-seeking behaviour of professionals, working within the pharmaceutical manufacturing sector in Ireland

Browne

Μαρτζούκου

2022

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“…W odniesieniu do metod obiektywnych w systemach produkcji biomedycznej stosuje się analizę OEE (ang. Overall Equipment Effectiveness) oraz monitorowanie kluczowych parametrów wydajności procesu [7] KPI (ang. Key Performance Indicators).…”

Section: Wyniki Wdrożenia Zaproponowanego Modeluunclassified

The Model of Development of Production Process in Biomedical Production Plant

Dębowski¹,

Szewczyk²,

Gudanowska³

2019

PAR

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Zezwala się na korzystanie z artykułu na warunkach licencji Creative Commons Uznanie autorstwa 3.0 WprowadzenieOd początku XXI wieku w krajach wysoko rozwiniętych można zaobserwować intensyfikację procesów społecznych związanych z problemami starzejącego się społeczeństwa. Równocześnie, starzenie się społeczeństwa prowadzi do gwałtownego wzrostu wydatków na służbę zdrowia, w szczególności na okulistykę. Przykładowo wydatki na operacje zaćmy w Polsce w latach 2015-2017 wzrosły trzykrotnie [1]. W rezultacie starzenia się społeczeństwa, gwałtownie wzrosło zapotrzebowanie na zaawansowane produkty biomedyczne, takie jak na przykład soczewki wewnątrzgałkowe.Produkcja wyrobów biomedycznych jest jednym z najbardziej technologicznie zaawansowanych obszarów inżynierii produkcji. W odróżnieniu na przykład od produkcji w branży motoryzacyjnej, produkcja biomedyczna jest przedmiotem ścisłych regulacji prawnych, określających zarówno nadzór nad półproduktami, sam proces produkcji, transport, magazynowanie oraz utylizację zużytych wyrobów biomedycznych. Autor korespondujący:Roman Szewczyk, rszewczyk@onet.pl Artykuł recenzowany nadesłany 01.03.2019 r., przyjęty do druku 25.03.2019 r.

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“…These will be discussed together with few examples in the later sections.KM indicators appear to be the least developed resource and have not been applied to any QbD specific goal, despite being praised in management areas for give direction to different kind of initiatives (64,65). …”

Section: Reuniting the Viewpoints: Km In The Industry And Academiamentioning

confidence: 99%

Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals

et al. 2016

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Knowledge Management (KM) is a key enabler for achieving quality in a lifecycle approach for production of biopharmaceuticals. Due to the important role that it plays towards successful implementation of Quality by Design (QbD), an analysis of KM solutions is needed. This work provides a comprehensive review of the interface between KM and QbD-driven biopharmaceutical production systems as perceived by academic as well as industrial viewpoints. A comprehensive set of 356 publications addressing the applications of KM tools to QbD-related tasks were screened and a query to gather industrial inputs from 17 major biopharmaceutical organizations was performed. Three KM tool classes were identified as having high relevance for biopharmaceutical production systems and have been further explored: knowledge indicators, ontologies, and process modeling. A proposed categorization of 16 distinct KM tool classes allowed for the identification of holistic technologies supporting QbD. In addition, the classification allowed for addressing the disparity between industrial and academic expectations regarding the application of KM methodologies. This is a first of a kind attempt and thus we think that this paper would be of considerable interest to those in academia and industry that are engaged in accelerating development and commercialization of biopharmaceuticals.Electronic supplementary materialThe online version of this article (doi:10.1007/s11095-016-2043-9) contains supplementary material, which is available to authorized users.

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The Utilization of Quality KPIs in the Pharmaceutical Industry

Cited by 8 publications

References 10 publications

An investigation into the information-seeking behaviour of professionals, working within the pharmaceutical manufacturing sector in Ireland

An investigation into the information-seeking behaviour of professionals, working within the pharmaceutical manufacturing sector in Ireland

The Model of Development of Production Process in Biomedical Production Plant

Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals

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