Articles in this Issue
Igor Gorsky
This article is the second part of an article titled, “How Clean is Clean in Drug Manufacturing?” The first article reminded practitioners that Cleaning is an official process, and introduced the term Equipment
Cleaning Process (ECP) which will be used in this part as well. In addition, that article described tools that may aid practitioners in the establishment of appropriate residual limits.
Robert Chimenti, James Elliott, Rashid A. Bux
Over the past decade, Raman spectroscopy has become a “household name” in the pharmaceutical industry mainly because of its widespread use in areas such as incoming material inspection, counterfeit/adulterated drug screening, and process monitoring. Lesser known is how heavily Raman spectroscopy is being investigated in the biomedical industry as a screening tool for various diseases including cancer.
Susan Dana Jones, Thomas C. Ransohoff, Frank Castillo, Frank J. Riske, Howard L. Levine
Development of a robust, reproducible biopharmaceutical manufacturing process is a critical path activity in the overall early development timeline. Platform processes have enabled companies to perform process development in shorter timeframes
for molecules such as antibodies. However, technical challenges and regulatory requirements are more easily met by obtaining
more process performance data during development and gaining a good understanding of critical process parameters.
Michael Fowler
As noted recently, FDA has issued several guidance documents to encourage companies to implement components of Quality by Design (QbD) into various phases of product lifecycles, with an emphasis
on product development. Companies are expected to incorporate basic QbD elements in ANDA product filings and transition to more complete QbD filings as industry and regulatory agencies sync knowledge gained from successful and unsuccessful experiences.
Kate Hammeke
One of the key tenets of behavioral research in the consumer environment is that it is easier to adapt to your customers’ behavior than to change their actions to accommodate your sales approach (eg,
store layout, intended product usage, etc). There are few exceptions to this rule; a key example is the refrigerated section of the supermarket being located at the back of the store.
Gary E. Ritchie, MS
Brand protection is a strategic imperative for every pharmaceutical manufacturer, packager, and distributor. Maintaining supply chain integrity and keeping patients safe presents perhaps the greatest
challenge to companies in the drug marketplace, including branded, generic, and over-the-counter products.
Jeffrey Stults, PhD
Solid form screening has become an important activity in drug development. The initial screening activity is designed to find an acceptable physical form of the active pharmaceutical ingredient (API)
for development.
Ila Patel, C.J. Venkatramani, Colin D. Medley, Kavita Mistry, Larry Wigman, Ph.D., Nik Chetwyn, Ph.D.
The presence of residual metallic impurities is an issue of increasing importance and concern to regulatory agencies around the word to ensure patients’ safety. Several common metals such as cadmium, lead, mercury, and arsenic are known to impact human health negatively, and agencies have set strict exposure limits to minimize exposure to
humans.