Melkor
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Greece,
2015-10-11 21:49
(3109 d 08:14 ago)

Posting: # 15551
Views: 2,247
 

 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 :-)
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