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Dear experts, according to GMP requirements, the calibration of weighing instruments in the production area must cover the entire range. How can this requirement be met?
Hello, in accordance with GMP requirements, calibrating weighing instruments over their full range typically requires the use of a series of known standard weights of different masses. The mass of these weights should be evenly distributed across the entire range of the weighing instrument. The specific steps are as follows: 1. Prepare a set of standard weights with acceptable accuracy that cover the entire range. 2. Clean the weights and the scale platform to ensure there is no dust, contamination, or other environmental factors affecting them. 3. Allow the instrument to warm up to a stable state. 4. Starting from zero, place weights of different masses one after another and record the display value of the scale. 5. Increase the weights one by one in ascending order, and then decrease them one by one in descending order; repeat this process several times to check the repeatability and regression error of the scale. 6. Check whether it is within the allowable error range by comparing the scale’s indicated value with the actual mass of the weights. 7. If the scale’s reading deviation exceeds the specified error range, it needs to be adjusted or repaired. 8. A calibration report is issued upon completion of the calibration. The frequency of calibration and the specific procedures may be influenced by local regulations and the internal standards of the pharmaceutical company. This process may also need to be carried out by an accredited calibration service provider. .
Weights fully equipped in accordance with the requirements of the calibration procedures