Anyone able to advise what is the minimum valid sample size for a validation run in order to give a meaningful conclusion that the result is a representation of actual production condition.
[left]In a nut shell…
Too vague a question to answer as posed.
Sample sizes are based statistically based on two factors Alpha risk and Beta risk.
One develops a sample size keeping both of these risks in mind.
The confidence in the populations changes as these risks are increased or decreased.One needs to assign these Alpha & Beta Levels upfront.
Other factors come into play, is this a single or double sampling plan?
What does the acceptance criteria need to be a=0, R=1 or can we tolerate a=2 R=3?? Are we sampling attribute or variable data? When we know all these factors a valid and statistically based sample size n can be assigned.
i am new user of this site, and also a junior chemist in parenteral manufacturing plant at India.
please tell me about alpha and beta risk, how these can affect the quality of parenteral formulation.