Pharmaceutical Engineering® Reader Picks for April 2025
Each issue of Pharmaceutical Engineering® covers a wide range of topics relevant to the pharmaceutical industry, including scientific, technological, and regulatory advancements throughout the entire pharmaceutical lifecycle. In April articles about India's pharmaceutical manufacturing industry, fleet management, AI validation, stability studies, and supplier qualification for raw materials were among the top articles. Here's the list of the most-viewed articles from the past month:
Indian Pharmaceutical Industry Creating Global Impact
India’s pharmaceutical sector is not only a cornerstone of its national economy, but it’s also a pivotal player on a global stage. As of 2023, India ranked as the third-largest producer of drugs and pharmaceuticals by volume, with a 20% global share in the export of generic drugs. READ MORE
The Power of Fleet Management in Distributed Manufacturing
The pharmaceutical industry faces significant challenges in rapidly expanding production capacity to meet the needs of patients. This article proposes a regulatory framework for distributed manufacturing using the concept of fleet management to address these challenges. READ MORE
AI Maturity Model for GxP Application: A Foundation for AI Validation
The assurance of integrity and quality of outputs via computerized system validation is essential for applications in GxP environments. If validation is not considered from the beginning, there is considerable risk for AI-based digital pilots to get stuck in the pilot phase. READ MORE
Identifying Out-of-Trend Data In Stability Studies
Out-of-trend (OOT) data results should be limited and scientifically justified, but historically, there have been different approaches to identify OOT. These approaches are easy to understand and implement. They also do not require different limits for each time point. The major disadvantage of these approaches is that they lack statistical basis, which raises questions about the reliability of these approaches to clearly and precisely detect OOT. READ MORE
Introduction to Steam Quality and Testing
Steam is the most powerful and effective thermal energy transfer fluid, and its use continues to grow in process industries around the world. This article provides the background and science behind the steam quality tests and proposes a risk-based approach to the routine monitoring of steam quality for a system providing steam to all pharmaceutical applications/autoclaves. READ MORE
Supplier Qualification Program for Key Raw Materials
The pharmaceutical industry has been scrutinizing raw material suppliers with more rigorous qualification programs to determine if they can provide the necessary goods and services to the standards required by companies meeting good manufacturing practices (GMP). READ MORE
A Skill Management Framework for a Pharma 4.0™ Workforce
Pharma 4.0™ is driving fundamental industry changes and requires a comprehensive approach to workforce development. This article proposes a skill management framework aimed at empowering companies to develop a future-ready workforce, including practical insights within the context of Pharma 4.0™. READ MORE
Continuous Process Verification in Stages 1-3
This article describes an approach for implementing continued process verification through the core concept of design space based on online multivariate data analysis (MVDA) and Monte Carlo random simulation. READ MORE
Room Differentials Pressures in Facility Design: Fundamentals
The expectation for room differential pressures to maintain air quality in pharmaceutical facility design are consistent and well defined from a regulatory perspective. However, there is no common approach to the design, monitoring, or alarming of area differential pressures. This article explores differential pressure concerns in aseptic manufacturing, or cleanroom classes B, C, and D. READ MORE
CMC Requirements for New Drug Registration in Latin America
The global pandemic demonstrated that the pharmaceutical industry needs to work toward a global solution and prioritize the harmonization of technical requirements. This article offers an overview of the chemistry, manufacturing, and controls (CMC) requirements for the small molecules product registration process in Latin America and highlights the divergence of some requirements from harmonized standards like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). READ MORE
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