Research Triangle: Building a Foundation For Pharmaceutical and Biotechnology Excellence
Cover: North Carolina’s Research Triangle is the largest of its kind in the US. Thanks to years of effort from industry, pharmaceutical professionals, and education institutions, it is synonymous with pharmaceutical and biotechnology excellence.
CMC Requirements for New Drug Registration In Latin America
Feature: The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements. Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America. 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).
A Proposal for a Comprehensive Quality Overall Summary
Feature: When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,” which can reduce review efficiency. This structure does not allow explanation of justification for the control strategy, particularly when a quality by design (QbD) approach is employed. The authors propose using Module 2.3 to effectively convey the control strategy and clearly identify the established conditions (ECs) or regulatory binding elements that “are considered necessary to assure product quality and therefore would require a regulatory submission if changed post approval.”
Enhanced Intervention Detection in Aseptic Fill Using AI/ML
Technical: Authors show how continuous, real-time capturing of data with immediate data analysis by an ML algorithm can improve control over a critical quality attribute. The MLanalyzed data provides the evidence for validation of the change by demonstrating more control over the process along with a decrease in process risks.
Methodology to Define a Pharma 4.0™ Roadmap
Technical: In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. The key to data integrity compliance is a well-functioning data governance system in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map.