Statistical Services in Stability Testing and Process Control

Stability Testing

Stability studies are performed in order to validate the integrity of the final drug product under various defined conditions.
We provide statistical support to stability studies as per the ICH guidelines.

Our services include:

  • Fitting best statistical model to the observed data(linear or non linear)
  • Data extrapolation using model results
  • Estimation of Shelf Life

Statistical process Control

  • Control Charting using Individual and Moving Range (I-MR) control charts
  • Control charts provide evidence of whether or not a process has been operating in a state of control.
  • Process capability is a measure of how well a process is currently behaving with respect to its output specifications. It is determined by the total variation that comes from common causes and represents the performance of the process itself when it is being operated in a state of statistical control.

303, B Wing, Kohinoor Building Plot No 479, 24th Road,
Khar West, Mumbai 400052