Page 24 - Packaging Controls
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GMP Training – Packaging Controls by www.gmpsop.com
Target Fill
Lower specification limit (LSL)
Upper specification limit (USL)
Actual progressive volumes dispensed over time
For instance, 100ml bottles of a Product are being filled from a packaging line.
Following are the fill specification for the product:
Stated volume on bottle: 100.0 mL
Target volume: 105.0 mL
Lower limit (LSL): 103.5 mL
Upper limit (USL): 106.5 mL
From the Run Chart diagram below, it appears that some points are above and
below the upper and lower specification limits. This would mean that the process
would have to be adjusted and perhaps the batch would need to be quarantined.
The run chart, though, does not provide any indication whether the process has
consistent (predictable) variation, or whether it is "out of control".
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