Lean Validation in the Pharmaceutical Industry in Ireland
In this study, it was shown that implementing Continuous Improvement (CI) initiatives has been done within Pharmaceutical Validation in Ireland, to some extent. ‘Lean Validation’ is a concept that involvesthe implementation of CI initiatives into the process of Validation. Within the Pharmaceutical Industry, there is an enduring interest for an organisation to reduce waste and improve the efficiency of a process. Validation is a core pillar of the Pharmaceutical industry and the process can often be long, tedious and inefficient. This ideology behind ‘Lean Validation’ is to use tools from principles such as Lean and Six Sigma to reduce waste and improve the Validation process. The objectives of this research were to explore the extent to which organisations are currently implementing ‘Lean Validation’ principles, what the current challenges with implementing them are, and what specific areas and tools could be the most beneficial to focus these initiatives on within the Validation process. This research was conducted using a mixed-method approach, consisting of a survey and interview. The analysis of the data showed that CI tools and initiatives have been implemented within the Validation process, with the main goal of this to improve the efficiency of the process and to remove any aspect of the process that does not add value and can be considered ‘waste’ under Lean methodologies. The data showed there is some level of reluctance to implement CI within Validation, with the main challenges being lack of time and resources, and lack of engagement from personnel due to a ‘fear of change’. The study concludes that CI initiatives can be beneficial for the Validation process in a number of areas and provides suggestions for Pharmaceutical organisations looking to implement them and recommendations for further study.