Re: Single batch spanning more than a shift

["Colin Meldrum" <cmeldrum@cogeco.ca>(by way of John Dolman<moderator@the-dolman-consultancy.com>)]

Maureen
The "dim" reference you speak of was originally incorporated in
the never
enacted (but often referenced) FDA 1976 LVP Document. It basically
stated
the batch requirement not to exceed what could be manufactured and filled
in
an 8 hour shift.
Thankfully we no longer see the need for such a requirement as validation
of
our processes have advanced beyond that initial state.
You will find many instances in industry where the batch is defined as
1
tank or multiple tanks of the same product filled over a continous 3 day
run
or even , in my experience , over 6 or more days. The testing to allow
this
to happen is not insignificant but the upside is huge with no
detrimental
effect upon the customer.
In short, it is up to you to define your batch and validate it
accordingly.

Respectfully
Colin Meldrum