Pharma 4.0 Quality Management Challenge: A Literature Review

摘要

This paper aims to review several related papers on Quality Management and Industry 4.0 in the pharmaceutical industry environment to achieve the benefits required future and give a better vision of the extant regulatory and technical barriers for realizing it. Quality Management and industry 4.0 require efforts to better understand a GMP (Good Manufacturing Practices) pharmaceutical industry situation. Product quality in the pharmaceutical industry is a fundamental thing that must be achieved as a fulfillment of regulatory requirements. GMP for the Pharmaceutical Industry is a minimum standard of compliance for the pharmaceutical quality system requirement that must be designed, applied, managed, and maintained properly so that the main objective is achieved where the production process so that medicinal products always have robust quality in fulfilling efficacy and patient safety. Industry 4.0 in the pharmaceutical industry (which is popular with the term Pharma 4.0) is challenging to implement within the GMP 'high-regulated industry' environment. It will have consequences to moving transition into it step by step in a delicate careful slide. The internet of things (IoT), artificial intelligence (AI), robotics, machine learning, cyber-physical system, and advanced computing as a character of industry 4.0 will dramatically change the landscape of manufacturing including the quality system inside. The research results presented in this paper show an increasing trend towards research that focuses on the slices of 'quality management', 'pharmaceutical quality system' and 'industry 4.0'. Further research needs to be done to create a pharma 4.0 quality system implementation model.