June 2008 Issue
Our latest operational excellence survey suggests that tools aren't always aligned with goals, and that more management support is needed.
The Heparin case provides an excellent opportunity to use risk analysis, as defined in ICH Q9,to look at the costs of outsourcing manufacturing to China.
How can pharma reach the Desired State when so many of its workplaces still encourage technicians and operators to make mistakes?
Process complexity is the leading source of pharma quality problems, and error proofing offers a sure return on investment.
Drug safety is a multifaceted question. Lets be reasonable before going Chicken Little on the industry.
Developing a model and using the same control system from development through manufacturing can improve process control
The industry is adopting benchmarking with a vengeance, to good effect.
Noncompliance appears to focus on the same issues: inadequate SOPs, root cause analysis and CAPA
Rapid Microbial Testing Methods address micro-hold, the last frontier for reducing process time and waste
Its impact on ball valve seals and clamp-type fittings poses a serious contamination risk, for utilities and processes