MHRA regulatory issue [Regulatives / Guidelines]
Greetings,
I was wondering what are the requirements for a variation in MHRA for change of FDF manufacturer for a oral liquid product. I guess that a process validation is essential is it though also a minimum stability data required in order to proceed with the submission of the variation?
Thank you
I was wondering what are the requirements for a variation in MHRA for change of FDF manufacturer for a oral liquid product. I guess that a process validation is essential is it though also a minimum stability data required in order to proceed with the submission of the variation?
Thank you

Complete thread:
- MHRA regulatory issueMelkor 2015-10-11 19:49 [Regulatives / Guidelines]