Journal
CHEMICAL ENGINEERING RESEARCH & DESIGN
Volume 83, Issue A6, Pages 730-738Publisher
INST CHEMICAL ENGINEERS
DOI: 10.1205/cherd.04359
Keywords
pharmaceutical industry; continuous processing; good maunfacturing practice; barries to change
Categories
Ask authors/readers for more resources
The pharmaceutical industry is a highly regulated industry and all production must be carried out in accordance with good manufacturing practice. Traditionally, virtually all manufacturing operations have been carried out batch wise in spite of cost disadvantages and the fact that in many cases continuous processing could lead to the manufacture of purer products. The regulatory environment tends to stifle any attempts to change the process once the development stage is over and the product and process have been licensed. This has created a mind set amongst the industry's professionals that batch processes are the only acceptable way forward. However; the regulatory authorities, particularly the Food and Drug Administration in America, have recognized that continuous processing has the potential to improve product quality and are encouraging the industry to reconsider their ideas. This paper examines how chemical engineers can use the opportunity that arises from this changed regulatory environment to revisit their own ideas and drive a change of mind set within the industry.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available