How do you qualify a supplier who is not willing to complete the requested documentation such as a questionnaire and Quality Technical Agreement? (for example, a critical material supplier when there is no back-up option). I find more and more ...
Qualistery – GMP Knowledge Provider Latest Questions
Anonymous
Asked: In: Manufacturing
Dear GMP colleagues, I have a question about how to increase tablet hardness without affecting other critical parameters of the tablets. Our problem at the moment is that our CMO in Asia produced the domperidone tablets within the specifications [40-120N], i.e. ...
Do yo routinely test for the silicone oil in your DP when filled in siliconised prefilled syringes? If so, what analytical method do you use?