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.
RECEIVED AWARD AS BEST PHARMA CAREER PORTAL AT ISFCP
AWARDED AS BEST PHARMA PORTAL BY IPA
Copyright © 2008-2020, PharmaTutor Edu Labs