An Appraisal of Adoption Status of “Quality By Design” Approach in Pharmaceutical Industries in Himachal Pradesh, India
Keywords: Pharmaceutical manufacturing, Pharmaceutical Quality, QTPP, Quality by Design (QbD), Risk Assessment, Risk Management.
AbstractThe present study aimed to evaluate the current status and adoption of the quality by design (QbD) approach in the pharmaceutical industries of Himachal Pradesh. The study was conducted by distributing a well-designed questionnaire survey, and data were collected electronically. In the study, the status of QbD adoption among pharmaceutical industries of Himachal Pradesh was investigated and also aimed to evaluate the factors influencing the QbD adoption. A total of 112 pharmaceutical units were enrolled initially for the study, but finally, 100 units participated in this study. A total of 97 responses were received and analyzed by Statistical Package for Social Sciences (SPSS) to derive the inferences related to QbD adoption status and the factors influencing QbD adoption. The results revealed a significant degree of QbD adoption among the participant pharmaceutical units. A total of 14 factors had been identified with 57 indicators. It has been observed that the key area where the adoption of QbD influences the industry output are ‘Risk Assessment and efficient management of the unit’ with the highest eigen-value at maximum variance and highest factor loading. This identified factor (F1) was found to be a crucial element in QbD adoption. The study indicated the identification of several factors for a successful QbD adoption and implementation in pharmaceutical manufacturing and the regulatory authority should inspire, be aware and support the companies by organizing consistent workshops, seminars, and pre-designed training programs.
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