Reassessing the ADC Analytical Control Strategy

Time: 3:00 pm
day: day 1 track 5 pm


• This case study intends to
demonstrate the value of
reassessing the ADC analytical
control strategy (release,
in-process, stability testing)
– combining evaluation of
historical manufacturing data
and review of process and
product knowledge.
• Examples will show how
assessing historical data,
reviewing quality attribute
criticalities, identifying testing
that is redundant or orthogonal,
and understanding process
control elements, may be used to
“lean-out” the analytical control
strategy without adding risk to
product quality.
• This systematic science and riskbased
approach is supported by
ICH guidance and QbD principles
and may be applied across the
ADC product analytical lifecycle.