Jeffery
I can,t give you an official position, what you describe is unusual,
but if there are sufficient safeguards built in and they can be
validated I don't see why the system should be rejected.
I can't find the CFR reference (I'm sure somebody will enlighten me),
but the EU guide requirements are general and only (ONLY!) require
correct materials, accurately weighed, independent checking, clean
labelled and appropriate containers and materials for each batch kept
together.
Question 1 - is this gang dispensing restricted to identical products
or all those dispensed within one day? I would have no query with
identical products, but have some reservations on potential for cross
contamination and confusion for non identical products.
Question 2 - dispensed materials have to be collated and are normally
shipped to the production dept. in locked cage pallets. Will there be
unnecessary clutter in the dispensary with 10 or more cage pallets
being service?
Alan Newbery
alan.newbery@parexel.co.uk
______________________________ Reply Separator _________________________________
Subject: Chemical Dispensing Operation
Author: MODERATOR <moderator@pda.org> at Internet-UK
Date: 05/01/99 16:33
We require the official position regarding 'gang' weighing of ingredients for
pharmaceutical batches which have some or all common ingredients. For those not
familiar with the term it involves the weighing of one or more quantities of
active ingredients or excipients for several batches of the same or different
products. For example if one needed 'x' amount of sodium chloride for ten
batches, one would weigh the ten quantities, one at a time, into their
intermediate containers, label appropriately and then stage them in a secure
area while the remaining ingredients were weighed. Following that, all
ingredients for a given batch would grouped together then sent to the
compounding area to produce the different lots of the same or different products
etc.
Gang weighing was frowned upon in the past because of the enormous potential for
mix-ups and the need for stringent controls both of which more than outweighed
any possible benefit of greater efficiency in this critical operation. (It
avoids having to thoroughly clean the area between each ingredient)
With the coming of age of powerful, properly validated, integrated dispensing
systems, control and traceability of each container can be assured and
validated. The dispensing system schedules the weighing tasks based on a
variety of factors: production schedule requirements, chemical availability,
operator availability, operator training, time of day and would be tied into ERP
and LIMS. The unique labels printed by the dispensing system would be applied
to every container and the bar code would then be checked with a reader before
the bag was added to the specific batch.
Comments? What are most companies doing at this time? Or is this categorically
forbidden regardless or how it is done and the safeguards and validation that
are in place that would guarantee a quality product.
Thank you for your help in this matter.
HAPPY NEW YEAR!
Jeffrey H. Brooks
jeffrey.brooks@walshautomation.com
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