Role of the organized sector in developing small-scale industries as vendors: A case study of experimental approach

Chowdhury, Kalyan Kumar; Gijo, E.V.; Hegde, S G

doi:10.1080/0954412006900

Cited by 1 publication

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“…World over industry in general has recognized statistically designed experiments as an essential part of any product development activity which lead to reduction in time-to-market while ensuring high quality with reduced variation. The application of statistically designed experiments is reported widely in literature during the past two decades (Chowdhury et al , 2000; Gijo and Scaria, 2013; Ruggeri et al , 2007, Bhat et al , 2020). DOE is one of the most widely used tools for process optimization and product quality improvement in various industry sectors like automotive, aeronautical, mechanical, biomedical and pharmaceutical industries (Costa, 2019).…”

Section: Literature Reviewmentioning

confidence: 99%

Application of tools and techniques of quality by design in pharmaceutical process

Gijo

2021

IJPPM

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PurposeThe purpose of this article is to demonstrate the application of the tools and techniques of Quality by Design (QbD) approach in an Indian pharmaceutical drug product manufacturing company and to understand the challenges, managerial implications and lessons learned while implementing this initiative.Design/methodology/approachThis work adopts the Action Research methodology for impurity reduction in a drug product manufacturing company in India by using the tools and techniques of QbD approach. Various QbD tools like Design of experiments, process capability evaluation and control charts were effectively utilized for the study.FindingsAs a part of QbD implementation in the organization, a specific drug product was identified and the impurity level in the product was studied. Significant variables impacting the impurity were identified and the optimum levels for the significant variables were identified through design of experiments. The solutions were implemented and the impurity levels were reduced significantly.Research limitations/implicationsEven though the article is based on a single case study related to tools and techniques of QbD in a single organization in India, the identified problem is a generic product quality related issue for any pharmaceutical drug product manufacturing company. Hence the findings of this research are applicable to pharmaceutical drug manufacturing industry in general.Originality/valueThis article illustrates the systematic usage of various tools and techniques of QbD methodology in a pharmaceutical drug product manufacturing company. The usage of Design of Experiments for process optimization and application of other tools and techniques are ready references for the practitioners and novice users in the field.

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Section: Literature Reviewmentioning

confidence: 99%

Application of tools and techniques of quality by design in pharmaceutical process

Gijo

2021

IJPPM

View full text Add to dashboard Cite

show abstract

Role of the organized sector in developing small-scale industries as vendors: A case study of experimental approach

Cited by 1 publication

References 0 publications

Application of tools and techniques of quality by design in pharmaceutical process

Application of tools and techniques of quality by design in pharmaceutical process

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