(306a) 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

Abstract

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.