November/December 2006 Issue
Its time to emphasize the P, and de-emphasize the A and the T in PAT, says our intrepid columnist.
A packaging expert offers pointers on what pharmaceutical manufacturers need to know and to specify in order to ensure favorable outcomes.
GSK has sent its sales reps out to improve the industry's image, but last August, Talecris Biotherapeutics allowed its manufacturing and development staff to become industry spokespeople. Could this be the wave of the future for pharma?
Six Sigma can, and should, become a way of life for mid-level manufacturing executives, directors and managers.
The 450-page Pharmaceutical Manufacturing benchmarking study released in October offers a gold mine of information on how to improve, for those industry professionals and regulators brave enough to dive into the data. In this feature, Jeff Macher and Jackson Nickerson discuss challenges they faced, study results, a major caveat and future plans.
Drug manufacturing can only advance if drugmakers, regulators, academics and vendors join forces to mine and interpret new data.
Technology transfer was once taken for granted as something that would get done anyway. Now its an indicator of manufacturing excellence and a core competency for drug innovators.
The new pill-cutting reality requires an understanding of bisect functionality
As new players enter the market and a standard is proposed to ASTMs E-55 committee, a great deal of controversy is swirling around on-line TOC analysis for pharmaceutical-grade water. The worlds leading technical experts are aligned with one vendor or another, so its up to the user to filter through the marketing-speak and determine which technology will best meet specific installation needs.
Robust analytical TOC method validation is essential to the success of any on-line TOC system, particularly systems that release pharmaceutical-grade water in real time. Meeting USP 643 or EP 2.2.44 specifications may not eliminate risk.
The U.S. Pharmacopeia's program is designed to assure manufacturers, regulatory authorities and consumers that drug substances and excipients bearing the USP Program Mark are of consistent, high quality.
Cost efficiencies are driving increased use of FFS in liquid parenteral drug packaging, but attention to process parameters, testing and validation is critical