Examination and evaluation of GMP-compliant pharmaceutical production standards in the context of industry 4.0

Roland Wölfle

Journal of Applied Leadership and Management, 2021, vol. 9, 16-31

Abstract: Research questions: Is it possible for pharmaceutical companies to apply the concepts of industry 4.0, such as the smart factory, completely in their GMP relevant production processes? Are the GMP guidelines generally open to modern production methods enabled by I4.0? Are those responsible in the pharmaceutical industry familiar with the possibilities of I4.0? Methods: Hypotheses are tested by means of quantitative primary research in form of an online survey. The people interviewed are from the fields of technology and maintenance, quality control and management of leading, globally active pharmaceutical companies. The questionnaire was developed specifically for the topic of this paper by literature research and personal communication with leading managers for strategic development in the pharmaceutical production branch. Results: The hypotheses could not be supported completely. The survey shows that the potential of industry 4.0 concepts has not yet arrived in large parts of the workforce and the management level. The GMP regulations allow innovations in many areas, but with considerable effort during the implementation phase. The complete introduction of a smart factory means a reinterpretation of the existing regulations. This leads to very cautious first steps which are in the area of employee support, not the introduction of new processes in the workflow itself.

Date: 2021
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