Read, Learn, Innovate: Pharmaceutical Engineering® Revisit Past Article of the Year Winners
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are a look back at past winners of the Roger F. Sherwood Pharmaceutical Engineering Article of the Year Award.
2018: Continuous Manufacturing In Biotech Processes: Challenges for Implementation
The article explores the promise and challenges of continuous manufacturing (CM) for biotechnology. CM in biotech offers the potential for greater product quality while reducing costs and shortening time to market. Challenges to be overcome include research and development efforts to characterize certificates of pharmaceutical products (CPPs) on single-unit operations and integrate them into the process; integrated control strategies or operations; technology available on the market; approaches to validation and quality; and regulatory compliance.
2017: A Holistic Approach to Production Control: From Industry 4.0 to Pharma 4.0
The current submission-based control strategy plays a key role in ensuring that critical quality attributes are met, and the quality target product profile is realized. It does not, however, consider GMP, facilities, utilities, equipment and other production-specific controls to mitigate risk and ensure an effective, reliable, and stable production process. In addition, the effect of unknown process parameters, raw material attributes, and impurities usually are not sufficiently addressed in the control strategy lifecycle management—it is often impossible to predict such variations for a production life cycle already in development.
2016: Balancing Pre- and Post-Market Control of Health Supplements
The growing market for health supplements, including varied terminology for medicinal and health products in this category, are explored in this article.
2015: Risk Analysis and Annual Training Program Definition
The article presents an example of risk analysis associated with quality assurance and an annual training program conducted by an Italian pharmaceutical company with the objective of reducing deviations linked to human error.
2014: Chemical and Media-Free Pretreatment for Biopharma RO–Electrolysis for Scale Precipitation and UV Dechlorination
This article identifies the issues plaguing water systems with reverse osmosis (RO) and defines the proper criteria of operation.
