A systematic review on implementing operational excellence as a strategy to ensure regulatory compliance: a roadmap for Indian pharmaceutical industry

Abstract

PurposeThe purpose of this study is to enhance the understanding of the complete process of framing and implementing operational excellence in the pharmaceutical industry to ensure higher regulatory compliance.Design/methodology/approachA literature search was conducted using preferred reporting items for systematic reviews and meta-analyses guidelines. Strategies were set with different keywords and certain assessment criteria for the inclusion and exclusion of articles. A total of 46 articles were considered for a full review.FindingsThis study describes the impact of implementing operational excellence in day-to-day operations and the driving forces to achieve the same. Seven commonly used enablers are described can be used in combination to develop and validate an assessment model. Case studies are summarized to schematize operational excellence programs for the scope of their industry.Research limitations/implicationsThis study is limited to Indian pharmaceutical manufacturers. It is implied toward small-scale manufacturers. It can be further extended to manufacturers from other regions.Practical implicationsThis study guides quality assurance managers, regulatory agencies and other top management to implement operational excellence to ensure higher regulatory compliance. It guides to develop a roadmap to operational excellence in their scope. This study is applicable to any manufacturing industry bound to comply with pharmaceutical regulatory standards.Originality/valueTo the best of the authors’ knowledge, at the time of publication, there are regulatory guidelines and some articles on various key enablers to achieve operational excellence. There is no published systematic review on achieving regulatory compliance by using operational excellence.