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Production Balance Daily Verification

Dear forum good morning.

If a balance (3 - 25 kg) is used throughout the whole range, what test weight would you suggest I use for the daily verification check? Any insight would be much appreciated.

Thank you

[quote=mtheodorou]Dear forum good morning.

If a balance (3 - 25 kg) is used throughout the whole range, what test weight would you suggest I use for the daily verification check? Any insight would be much appreciated.

Thank you[/quote]

Dear Mtheodoruo,
You should only used a balance at the middle third of its range. This is where the balance is most accurate.
If I used a 3 -25kg scale to measure say 5 Kg I would expect to be cited in a GMP audit for improper use of the balance.
Coming back to your question I would typically used standard weights that cover the lower, middle and upper range.

[quote=Fareastchris]Dear Mtheodoruo,
You should only used a balance at the middle third of its range. This is where the balance is most accurate.
If I used a 3 -25kg scale to measure say 5 Kg I would expect to be cited in a GMP audit for improper use of the balance.
Coming back to your question I would typically used standard weights that cover the lower, middle and upper range.[/quote]

Is there any documentation from any source that “they” would cite you for improper use of the balance. Being a Quality Assurance Tech, If I don’t see it in writing from a credible source and an explanation of the reasoning behind the purpose, I have a difficult time with the statement. Not trying to be difficult, I just want to understand the reason.

Thanks

[quote=asvedin]Is there any documentation from any source that “they” would cite you for improper use of the balance. Being a Quality Assurance Tech, If I don’t see it in writing from a credible source and an explanation of the reasoning behind the purpose, I have a difficult time with the statement. Not trying to be difficult, I just want to understand the reason.

Thanks[/quote]

If the production scale has been calibrated with its accuracy or measurement of uncertainty defined for the usable range and has met the production material accuracy requirement, I don’t see why will be cited in audit. Audit findings are specific, and `improper use’ is not specific for any CAPA.

Thanks

Minimum, mean and maximum operating ranges of the balance should be covered in the daily calibration.
In addition to the daily calibration linearity and eccentricity [corner load test] needs to be conducted in periodically.

[quote=mtheodorou]Dear forum good morning.

If a balance (3 - 25 kg) is used throughout the whole range, what test weight would you suggest I use for the daily verification check? Any insight would be much appreciated.

Thank you[/quote]

daily calibration needs to cover accuracy test for the entire operating range.

Monthly calibration needs precision and accuracy and uncertainty and eccentricity

[quote=asvedin]Is there any documentation from any source that “they” would cite you for improper use of the balance. Being a Quality Assurance Tech, If I don’t see it in writing from a credible source and an explanation of the reasoning behind the purpose, I have a difficult time with the statement. Not trying to be difficult, I just want to understand the reason.

Thanks[/quote]

You should read the GMP Guidelines more closely

PIC/S GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
PART I

Section 3.40.
Balances and measuring equipment of an appropriate range and precision should be available for production and control operations.

The WHO Guide says more or less the same, as do the US FDA CFR’s

This is a basic requirement

Your guideline for daily calibration of balance should be its Manual.Read the Manual of the balance and do what you read in the Manual.

[quote=Fareastchris]You should read the GMP Guidelines more closely

PIC/S GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
PART I

Section 3.40.
Balances and measuring equipment of an appropriate range and precision should be available for production and control operations.

The WHO Guide says more or less the same, as do the US FDA CFR’s

This is a basic requirement[/quote]

Where in the GMPs does it define the middle third of a balance’s weighing range as the appropriate range?

[quote=Fareastchris]Dear Mtheodoruo,
You should only used a balance at the middle third of its range. This is where the balance is most accurate.
If I used a 3 -25kg scale to measure say 5 Kg I would expect to be cited in a GMP audit for improper use of the balance.
Coming back to your question I would typically used standard weights that cover the lower, middle and upper range.[/quote]

If the balance is correctly calibrated and verified across its range you will NEVER be cited in an audit for use at lower or upper weight range.