Root cause analysis and process improvement of a nasal spray

Abstract

The following project has been developed in a pharmaceutical industrial environment at Merck, Darmstadt, specifically in the production and packaging of a nasal spray, which takes place at FAMAR, in Alcorcón. After receiving multiple complaints in which it was described that the product was open and its content spilled, Merck decided to perform a root-cause analysis of the aforementioned problem and to implement a CAPA plan in order to fix it, which consists in the implementation of a set of preventive and corrective measures, and at the same time, to improve the functioning of the production line by acting upon the deficiencies found in the analysis. The methodology followed to find the root of the problem has been a root cause analysis employing many analysis methods. First of all, a risk assessment of this type of incident has been done, as well as an exhaustive investigation of the process that the product takes in the production and the assurance of the Good Manufacturing Practices (GMP) and a study of the defective samples and the comparison against the retain samples. Concomitantly, a 6M (Ishikawa diagram) study has been developed in order to determine which factors have had an influence on the result and which have not and the data of the batches produced has been reviewed, including those batches with and without defective samples. Lastly, an identical case has been studied and an investigation action has been implemented. A sole root cause could not be found, however many contributing factors have been found, which has allowed, on one hand, to come up with corrective actions and implement them to fix the problem, and on the other hand, to reach preventive actions in order to avoid similar cases in the future, and once the weak spots and lacks of the production line were revealed, improve upon them. An environmental study can also be found in this project, where the impact of the development of the project upon the environment has been evaluated, taking into account the type of material that is used to package the product as well as the reagent employed to synthetize the product and its risks, and finally the carbon footprint that meant performing the project, analysing among other things, the energy consumed and the pollution created. Finally, an economical study of the cost of the project has been done. In this analysis, the costs of the used materials, products, power consumption, human resources and lastly the cost of the visits to the production site have been estimated.

Outgoing