2024

Bridging AI and GMP Standards in the Future of Pharma

by cyb2025

ELKE WIESER1, STEFAN PAULI2
1.VTU Österreich, Wien, Austria
2.VTU Engineering Schweiz AG, Muttenz, Switzerland

ABSTRACT

This article examines the integration of Artificial Intelligence (AI) in pharmaceutical manufacturing, particularly in regard to Good Manufacturing Practice (GMP) standards. While AI offers significant potential, challenges remain in regulation and validation. Regulatory bodies like the FDA and European authorities are working on incorporating AI into GxP processes, but specific guidelines are still in development. The report highlights recent advancements, including a proposed validation framework and examples of successful AI applications in GxP-compliant production. Overall, AI adoption in pharmaceutical manufacturing is advancing, but it should be approached cautiously to maintain product quality and patient safety.

CONCEPTS AND DEFINITION OF ARTIFICIAL INTELLIGENCE

Artificial Intelligence (AI) generally refers to machines that partially replicate human intelligence in an artificial manner. A fitting quote from Elaine Rich in 1983 defines AI as “the study of how to make computers do things at which, at the moment, people are better.” AI encompasses a variety of technologies, including machine learning (ML) algorithms that learn independently from collected data. These range from simpler methods like linear regression or random forests to more complex ones such as neural networks. The latter connect neurons in a network modeled after the structure of the human brain, linking one neuron (nerve cell) to a network of other neurons. Large neural networks are referred to as deep learning when they excel in processing images, text, or speech, although they require a significant amount of data and computational power. Therefore, deep learning is the closest approximation to the brain, although even here, much is simplified or adapted since our brain cannot be replicated one-to-one. Neurotransmitters in the human brain, such as dopamine, are not simulated, and the cells in the brain are organized in a linear manner rather than the more “chaotic” network found in the brain.
Thus, the term Artificial Intelligence leads through several intermediate terms like machine learning to the subcategory of deep learning.

 

HISTORICAL OVERVIEW OF AI

ABOUT THE AUTHOR

Elke Wieser has over 20 years of experience in the pharmaceutical industry. She has specialized in Bioengineering and Bioinformatics, with a strong focus on compliance. As Team Lead for Computer System Validation at VTU, she concentrates on the implementation of computer systems within the regulated GxP environment. Additionally, she is an expert on FDA and European compliance regulations, as well as data integrity issues. She plays a crucial role in VTU’s AI developments, ensuring their applicability in regulated areas.

Dr. Stefan Pauli is an expert in Data Science, Machine Learning, and AI. Since 2018, he has been working as a Senior Data Scientist / SME at VTU. After earning his PhD in Computational Science from ETH Zurich, he further honed his skills in algorithm development across various industries and start-ups. His diverse background enables a seamless integration of algorithmic solutions with industrial practice. At VTU, his focus is on implementing data analysis projects in chemical and pharmaceutical production.

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