264018 Evaluation of Process Capability and Robustness for a Lyophilized Product

Tuesday, October 30, 2012: 12:30 PM
Shadyside (Omni )
Michael M. Choi, GBPRD, Teva, West Chester, PA

Evaluation of Process Capability and Robustness for a Lyophilized Product

Michael Choi, Daniel Kim, Marazban Sarkari, Ronald Simko, David Unger, Stelios Tsinontides

Teva Global Branded Products Research and Development


Process capability for the manufacturing of lyophilized commercial batches at a new contract manufacturing organization (CMO) site was evaluated against the current CMO site using statistical process control (SPC) calculations.  Key process parameters, material attributes, and quality attributes were examined using univariate and multivariate control charts, Box plots, probability plots, and capability ratios.  Within[i] and between[ii] variations were evaluated to arrive at the type of control charts used in the analysis.  Outliers were verified using Box and probability plots in conjunction with control charts.  Simultaneous control charts were used to assess the impact of the critical process parameters (CPP) on critical quality attributes (CQA).  Overlaid control charts were used to compare CMO performances side by side.  The analysis was used to determine the adequacy of the controls and monitors at the new site, success of tech transfer, and impact of statistical outliers on critical quality attributes.

[i] variation within group of samples

[ii] variation between groups of samples

Extended Abstract: File Not Uploaded
See more of this Session: Process Robustness in Pharmaceutical Manufacturing
See more of this Group/Topical: Process Development Division