Why Pharmacopoeia recommends 6 or 12 units in Disintegration or Dissolution Testing?
Mean & Standard deviation (SD) of any in-process or finished product CQA represents Accuracy & Precision of any Statistically Contolled Stable Process or Method. In Disintegration & Dissolution test method, Mean & SD are the main parameters for evaluation and in a Control State of process/method, 99.73% of population data will be randomly normally distributed & will lie within the range of (Mean (+&-) 3SD) i.e. Total 6 SD. So, there will be only 0.27% probability that any observations falls outside this range.
Hence, if only Common Cause(s) of Variation are present within method or process, then all the data will fall within this range; if any value found outside this range then it indicates the presence of Special Cause(s) of Variation.
Data of 6 units will be assumed to lie within (Mean +/- 3 sigma = Total 6 SD), which will indicate Cp= 1.00 (minimum requirement in pharma industry), means it follows 3 sigma = 99.73% population data will lie within this range
While, if we consider 12 units, then all the data will be assumed to lie within (Mean +/-6 SD = Total 12 SD), which will give Cp=2.00, means it follows 6 sigma = 99.999998% population data will fall within this range)
More the Sample Size, less will the Variability of the process.
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