05-25-2017 01:04 PM
Can anyone shed like on the correct documentation and requirements for calibration of balances (analytical and toploader) for a 503A pharmacy? We requested our balances be calibrated to USP 41 and received a certificate of calibration that contains what seems to me to be in excess of USP 41 which states "weighing shall be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy."
Our reports states the procedure is USP 41. However, it lists repeatabiity, eccentricity, Linearity and sensitivity which seem in line with USP 1251. In addition, these reports also state a minimum weight which does not seem to be discussed in USP 41 but is in USP 1251. THese minimum weights are very large, especially for a pharmacy weighing small amounts. For example, one report has a minimum wt of 8.2 grams when the repeatability (10 times) as found showed ZERO error.
I have not gotten a great explanation except to find on my own that what they were saying I think is in USP 1251. We are not cGMP.
What do we follow and what should our documentation reflect??
Thanks for any input.