Question
Variability of the API amount in the bottles filled with pharmaceutical suspension is evaluated by analyzing the API content in each of the 20 bottles
Variability of the API amount in the bottles filled with pharmaceutical suspension is evaluated by analyzing the API content in each of the 20 bottles collected in a random sample from each batch and calculating the mean API content and %RSD from the sample data. The release specification for the commercial batches is that %RSD for the sample from that batch must be equal to or less than 6.25 %.
Should we use the same or different testing procedure and the acceptance criteria for that quality attribute during the PPQ Study to be conducted before starting commercial manufacturing of that product? Explain your answer.
Step by Step Solution
There are 3 Steps involved in it
Step: 1
Get Instant Access to Expert-Tailored Solutions
See step-by-step solutions with expert insights and AI powered tools for academic success
Step: 2
Step: 3
Ace Your Homework with AI
Get the answers you need in no time with our AI-driven, step-by-step assistance
Get Started