Balance Verification

GOOD MANUFACTURING PRACTICE (cGMP)
1

dear all,

Anybody can help in this matter.

we are a firm that performing periodical verification (Cornere Load, Leniarity, repducibility, off center) for all of our balances by the agent of these balances and by using clibrated weights. Ta the same time, we perform the A/M verification proceducre in house by using our calibrated weights. my Q. is, any statement in the regulations for a must for a third party (agent) to perform balnces veirifcation (double check)? if yes please attach these regulations.

thanks

jalal

2

Dear Jalal,

Pls refer OIML/PRL spec.- primary std wt should be calibrated by govt/other certified agency, balance cali. should be done ih

3

jalal,
if you have the required STD weights in house which is calibrated and has traceability to international standards then you can schedule all the calibrations in house. there is no regulatory recomendation that says that only a third party needs to do the calibration.
and ofcourse if you are installing a new balance then get the complete verification done by the vendor and if you are procuring the validation services from the vendor then get it done by them and future verifications can be done yourself and detailed in the respective SOP.
you got any better ideas let me know.

4

dear all,

thanks alot for your kind response, but there is some thing still not clear to me.

In my opinion, dealing with the balance by the third certified direction is better, becuse of the followings:

1- third party is accredated by ISO 17025, and give you approved certificate

2- third party deals with the uncertinaty of the balance more accurate than the user.

3- Third part deals with the minimum whigt more accurate

4- third part deals with the permisble error mor accurate.

your comments pls.

thanks

jalal

Head of validation and calibration since (1994)

5

Dear Jalal,

You are right in some extent, balances must be calibrated biannually or quarterly by any accrediate certified agency, however inhouse daily verification of balancing which cover entire balance range , must be log daily.

Regards,

[quote=jalal29]dear all,

thanks alot for your kind response, but there is some thing still not clear to me.

In my opinion, dealing with the balance by the third certified direction is better, becuse of the followings:

1- third party is accredated by ISO 17025, and give you approved certificate

2- third party deals with the uncertinaty of the balance more accurate than the user.

3- Third part deals with the minimum whigt more accurate

4- third part deals with the permisble error mor accurate.

your comments pls.

thanks

jalal

Head of validation and calibration since (1994)[/quote]

6

[quote=jalal29]dear all,

In my opinion, dealing with the balance by the third certified direction is better, becuse of the followings:

1- third party is accredated by ISO 17025, and give you approved certificate

2- third party deals with the uncertinaty of the balance more accurate than the user.

3- Third part deals with the minimum whigt more accurate

4- third part deals with the permisble error mor accurate.
[/quote]

Moreover, cross checking is always better.

7

[quote=jalal29]dear all,

Anybody can help in this matter.

we are a firm that performing periodical verification (Cornere Load, Leniarity, repducibility, off center) for all of our balances by the agent of these balances and by using clibrated weights. Ta the same time, we perform the A/M verification proceducre in house by using our calibrated weights. my Q. is, any statement in the regulations for a must for a third party (agent) to perform balnces veirifcation (double check)? if yes please attach these regulations.

thanks

jalal[/quote]

Dear all,
i also have same problem with jalal.
but in my place i used calibration in house and also external calibration.
why i use inhouse calibration coz i already been training from external vendor (also have certificate), and i also have mass standard that also has calibrate (certificate also). i’m doing in house calibration every 6 month (biannnualy)…i do this becoz i want to reduce cost for extenal calibration.
used to, i calibrate one a year (external calibration), now i can reduce form one a year to two year for external calibation.
i dont know if it can be accepted or not, but i asked an ISO auditor, he said it was acceptable if the mass standard also has calibrated.
but i dont know in GMP if it acceptable or not.

thanks