January 2007 Issue
PAT expert Emil Ciurczak points out that a repository of methods and standard practices, terms, units, etc. is critical to understanding (and thus controlling) the process of producing good, predictable, and reproducible solid dosage forms.
If youre launching Lean, be patient and stay the course, the Toyota disciple urges. Lean works, he says. It just takes a bit longer in pharma.
Failure Mode and Effects Analysis can help improve the safety of aseptic processing; using written and verbal brainstorming is key
With human-plasma-derived products, the potential for risk is high. Talecris Biotherapeutics QA process is designed to minimize risk all along the supply chain. SVP of Operations Mary Kuhn discusses how quality is maintained on the manufacturing plant floor.
Containment, lyophilization and cleaning validation all must be top priorities when producing cytotoxic agents.
Rapid Microbial Methods (RMMs) offer another tool that can facilitate Lean Manufacturing in biologics and pharmaceutical manufacturing, and taking the industry a few steps closer to parametric product release. Proactive communication with FDA reviewers was instrumental in getting approval for one RMM implementation project at a major pharma company. Rich Boehler discusses how his team at a previous (unnamed) employer went about the implementation.
An alternative approach uses physical methods to estimate the spectral signal and statistical methods to estimate noise.
Mitigating risks is a balance between the costs of applying security measures and the likelihood of an incident.
Following a proven framework can get an improvement program off the ground and ultimately, lead to success for managers at all levels.
Look past the equipment costs and concentrate on operating costs and the potential costs of downtime, and consider energy-efficient designs. Decisions should be guided by the Three Rs: redundancy, reliability and recovery.
Innovation is shortening time to market, reducing capacity requirements and improving yields