BMR release for packing activity


(Ankur Sukhija) #1

Is it necessary for a BMR to be released by quality head for initiating the packing activity or if there mention in any of the quality guidlines in context to this.


(Md.Asif Hussain) #2

Not necessarily, It actually depends upon the industry in-house practice…
However the comment should be mentioned that product has been manufactured as per cGMP practice and meets the specification requirements…
Thanks


(Md.Asif Hussain) #3

It’s also known as Batch certification


(Madeeha batool) #4

All activities performed during manufacturing initiated after the BMR release from the quality head. But it could be according to the in-house specifications.


(dushyant) #5

Not necessary but now day many organization follow such practice i.e.each & every stage(s) of manufacturing batch manufacturing record review through IH Quality check list for next stage.

For example:
Dispensing/Milling/shifting stage to Bulk (granules) manufacturing stage → Bulk (granules) manufacturing to compression stage → Compression to Coating/packaging stage