The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the qual...

The antimicrobial effectiveness test first appeared as a USP General Chapter in the 18th revision, official September 1, 1970. This chapter, at the beginning, was designed to evaluate the performance of antimicrobials added to inhibit the growth of microorganisms that might be introduced during or subsequent to the manufacturing process. As Good Manufacturing Practices (GMPs) became a governing...

Green supply chain management is an increasingly recognized practice among companies that are seeking to improve environmental performance. Of particular concern is how to arouse organizational awareness and put green activities into practice in order to enhance manufacturing performances. This paper investigates the correlation of green supply chain practices and manufacturing performances in ...

Industrial manufacturing of injectable drug products presents very different and difficult challenges when compared to other industrial manufacturing applications. In order to enhance patient safety and ensure product quality the Pharmaceutical Industry has been implementing systems called Advanced Aseptic Processing (AAP) systems. Advanced Aseptic Processing systems utilize advanced forms of a...

Lean manufacturing is an extended version of the Toyota Production System (TPS). It was highlighted as the best practice in the 21st century. Therefore, top and senior management in manufacturing firms are encouraged to adopt and adapt lean principles and practices in running their respective firms. The main objective of this paper is to investigate the extent of lean manufacturing perception a...

We study the impact of activity-based costing (ABC) on adoption of world-class manufacturing (WCM) practices and plant performance. In contrast to earlier research that estimates the direct impact of ABC on plant performance, we develop an alternative research model to study the role of world-class manufacturing practices as a mediator of the impact of ABC. Analysis of data from a large cross-s...

The capacity of small manufacturing firms to maintain reliable and continuously improving manufacturing processes appears to be a key condition for ensuring long-term sustainability. Governments have been very active in helping them tackle this challenge, in particular by supporting the adoption of world-class manufacturing practices. Despite the many benefits of this support, its application i...