This message was posted by a user wishing to remain anonymous
Venturing in to my first injectable PV, which is a clear solution, in a multi-use vial.
Wonder if anyone can share references to guidelines.
I have USP<71> that shows # samples to pull, but is there a need to perform CU?
Solution is made in a large vat before being vialled, so the assumption is that it's already homogenous. I found literature on tables and creams and semi-solids where it makes sense to do CU.
How do we go about pulling samples for PV homogeneity?
I couldn't find any specific suggestions, so would samples from beginning, middle, end of the batch be acceptable?
Or is there a specified approach?
Where this is a multi-use vial, is performing punctured vial stability a requirement?
Thanks in advance for your comments/suggestions.