Risk-based manufacturing gains steam at PDA

Risk-based manufacturing may soon be arriving at your plant. And it will be accompanied by risk-based auditing, updated techniques for process validation and verification and means to evaluate statistical methods for production.

All of these are PDA projects under way to improve pharma manufacturing processes. They're part of the Paradigm Change in Manufacturing Operations initiative. And they're nearing completion, says Stephan Roenninger of Roche, who chairs the initiative.

Roenninger says in Pharma QbD that after 18 months of work, 40 percent of the projects are more than half finished. Ten percent are nearly finished.

In the latter category are "Process Validation and Verification: A Life-Cycle Approach," a technical report that may be ready by the end of 2011, and "Utilization of Statistical Methods for Production and Business Processes," a report in development that will compile information on such statistical tools as Microsoft Excel, X-bar charts, histograms and process capability analysis. The purpose of the compilation is to illustrate the pros and cons of each.

The Risk-based Manufacturing task force is developing guidance for the application and implementation of quality risk management. Volume 2 of PDA Technical Report 44, Quality Risk Management for Aseptic Processes, is nearing publication. It will include annexes on biopharma manufacturing, sterile APIs and liquids, and packaging and labeling.

For risk-based auditing, the task force is compiling technical information concerning audits for not just manufacturing, but also lab, clinic and distribution processes.

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