MHRA regulatory issue [Regulatives / Guidelines]

posted by Melkor – Greece, 2015-10-11 21:49 (3913 d 11:09 ago) – Posting: # 15551
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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 :-)

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