ILDIKO ZIEGLER

Freelance Quality Compliance consultant, Budapest, Hungary

Abstract

In this article, we explore the current trends in high-potency active pharmaceutical ingredients, focusing on the impact of the human factor, outsourcing, and technological advancements. We also address critical issues of manufacturing such as containment and handling, cleaning and cross-contamination, and the ongoing challenges related to occupational health and environmental protection. Our goal is to provide insights that help navigate the complexities of HPAPI production and best practices in the industry.

INTRODUCTION
The process of introducing new pharmaceutical products is evolving. Novel therapies are becoming more complex, global supply chains are increasingly uncertain, competition is intensifying, regulatory scrutiny is more stringent, and timelines are tighter. As a result, pharmaceutical companies must adopt innovative approaches to ensure product safety and quality while maintaining swift market entry. Furthermore, significant trends like the shift towards personalized medicine and the emergence of artificial intelligence are transforming the industry, necessitating greater customization and adaptability for companies to stay competitive.
In the pharmaceutical industry - partly as a response to the issues just mentioned - APIs with strong biological effects are becoming increasingly widespread. High Potency Active Pharmaceutical Ingredients (HPAPIs) are sought after because they provide highly targeted treatments at lower doses, which leads to fewer side effects. They are versatile and are used in drugs for various conditions such as cancer, asthma, diabetes, and autoimmune disorders, etc.
No surprise, the market for highly Active Ph ...