Verification Balance


in the laboratory must have balances checked daily . I have a logbook where I write the checks .

GMP must also give evidence that the operator checked that balance are calibrated ? For exemple write in the logbook “verification OK"
"verification checked”

Balances must be calibrated before use. Since, they are used everyday this means they are calibrated (verified) daily. I think you have to go more ‘into the weeds’. That is;

  1. Identify the weight set used for calibration and when it was NIST verified and USP calibration due date.

  2. Put done the actual and theoretical numbers obtained.

  3. Write ‘Pass or Fail’ at the end

  4. Operator must initial and date entries above

  5. Laboratory management (Supervisor or Manager) must initial and date each page upon review.

Yes thanks. unfortunately I received a non-compliance on this.

the calibration of the balance has not been questioned. Instead they have contested fact that the analyst does not by evidence that has verified the successful daily calibration.

if I have not been clear I can explain again

Not surprised! Complying with my suggestions above will satisfy them. Just give them an implementation date and don’t be surprised when they follow up.

But I did not understand .
How can the analyst who must weigh GIVE EVIDENCE which verified that balance is calibrated ?

Documentation of verification (as I suggested) MUST be provided. Even Larry, Curly, and Moe (the 3 Stooges) can write ‘Verification OK’. The analyst must also answer the regulatory auditor’s (Government, QA or Client) effectively.

Always follow USP section <41> balances.

The USP 41 is not talking about pre-start check

cGMP requirements ARE always compulsary. Doesn’t matter whether it is pre-start or not.

Sorry … Where is it written ( in GMP ) that I must verify (writing) that someone before me has checked the balance ?

You must demonstrate ‘common sense’ as per ICH Q7, Q8, Q9, and Q10. No where are there ‘guidances’ that say ‘thou shalt’.

This is what we do.

  1. Before use you document on a spread sheet the scale ID, Serial, Model, Capacity etc.
  2. Check the Scale linearity, for example if the capacity of the scale is 200g we check at 1g,100g and 200.
  3. Acceptance criteria depends on the weight used.
  4. As mentioned your checks will have to include exp date of your NIST traceable weight standards.
  5. This is all done before the scale is used for any purpose daily.