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.
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
It’s also known as Batch certification
All activities performed during manufacturing initiated after the BMR release from the quality head. But it could be according to the in-house specifications.
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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