Bioequivalence and Bioavailability Forum

Dear all,

In analytical batch we are giving six QC samples in that

• Four QC samples should meet the acceptance criteria.
  
• 50% of QC samples should pass in each concentration.

This is the requirement to accept analytical batch regarding QC s.

Cases:
(For example if we take MQC)

1. Both QCs are not meeting the acceptance criteria.
   
2. Both QCs (MQC-1, MQC-2) has unacceptable internal standard response.
   
3. One QC has not meeting the acceptance criteria & remaining one has unacceptable internal standard response.

In case: 1 we considered that batch failure so we are doing repeat analysis for that batch.

In case of case: 2 & 3 whether we have to repeat the batch or not is there any scientific justification for that.

I would like to know various references/websites regarding this.