| Process Reliability and Flexibility -A Tool to Improve Pharmaceutical Plan Floor Operations David Geismar and Glenn White CSC Consulting Group, Global Health Solutions, Berwyn (USA)
The prime drivers affecting pharmaceutical manufacturers today are compliance (Good Manufacturing Practice) and cost. A popular way to address reduction of manufacturing costs is Lean Manufacturing, 6 Sigma, or a combination of the two (Lean 6 Sigma). If applied properly, these tools will also help ensure cGMP compliance. Two key elements to allow any Lean 6 Sigma program to function are process reliability and process flexibility. Process reliability is at the heart of any 6 Sigma program, and process flexibility is required to achieve the rapid changeover and reduced inventories required for lean manufacturing. By definition, process reliability will help ensure that a manufacturing process can be maintained in a compliant, validated state. In addition, process flexibility will be key to allowing manufacturers to make more customized drug products, which will be essential to keeping competitive in the future.
Key words Good Manufacturing Practices compliance • Lean manufacturing • Process flexibility • Process reliability • 6 Sigma • Uptime • Validation |
