July/August 2007 Issue
The CAPA is still necessary, but it needs to morph into something new under the QbD and PAT manufacturing examples.
We may not be hearing much about 21 CFR Part 11 lately, but that doesnt mean it is going away.
Rumors of 21 CFR Part 11s demise have been greatlly exaggerated. Data integrity is at the heart of numerous 483s and a recent lawsuit against Novartis.
Selecting a contract manufacturing organization (CMO) for aseptic processing of injectable final drug product (FDP) is no simple matter. Here are some dos and donts.
Companies are reducing operator error as techniques such as Jidoka begin to penetrate drug manufacturing facilities.
Alarm systems are often the first indication of whether underlying processes are understood and in control. Nuisance alarms must be eliminated and alarms categorized and prioritized so that their connection to product quality is clearly understood.
Often called 'automation with a human face', Jidoka is a pillar of the Toyota Production System. Pharma has yet to embrace the concept, although results of our 2007 survey on process control suggest that more facilities may be getting closer.
Immigrant education in math and science is discussed as necessary to U.S. Pharma, while readers respond to June's cover story on offshoring.
Comparing progress against a set of criteria such as Design for Lean Six Sigma ensures that the somewhat synchronous development philosophies of devices and drugs are being considered appropriately.
Controlling microbiological contamination is an ongoing process laden with risks. The best weapon against biofilm is prevention.