OR WAIT null SECS
March 02, 2009
The source of a problem reveals itself after some investigation, or it may crash down on you.
March 01, 2009
When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.
PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?
Enshrined in the concept of Quality by Design is the premise that optimized pharmaceutical manufacturing requires detailed understanding of products and processes. With this in mind, many benefits can be achieved by combining modern powder characterization techniques with real processing experience.
February 02, 2009
GMP experts act fast to resolve some unusual and difficult problems.
January 02, 2009
The authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.
Readers give advice on their best approach to handling (batch) rejection
December 02, 2008
When accusations fly: 'Tis better to give than to receive.
December 01, 2008
How has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future?
The closing date for comments to be received by the US Pharmacopeia (USP) for proposed revisions to Chapter , which deals with analysis of heavy metals, is 15 December 2008. The USP has been working towards for approximately 4 years and the task has not been easy.