E-DRUG: Expiry date versus batch number administration (2)
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Hi Ron, just my thought on this surely interesting case,
First of all a good SOP on batch numbers usually would disallow the use
of 0, O, o or I, i or | in the numbering system. That is one of the
documentation rules I learned while in the industry.
Your examples (01/31/11, 31-Jan-11 or 31012011) are clear, yet I would
see more of a risk in referring to only expiry dating such as 010408 or
080104, 201105 or 052011 for a product X manufactured by Y. These in
fact already start to look like batch numbers!
A batch number (or lot number) is mentioned on each label and on the
batch release certificate. It being a unique identifier (GMP: a
distinctive combination of numbers and/or lettersÂ…) for a batch often
combining a product code, date of manufacturing or sequential number and
/extension for packaging rounds, should be assigned by a SOP and is
meant to be provide a permanent trace to the manufacturing site and to
all pertinent batch production/control & packaging/control records. A
batch number with reference to manufacturer and product code makes good
sense to me. It has happened but very rarely and purely coincidental
that an identical batch number of a different product of a different
manufacturer shows up.
I think there is a different perspective here for a stores manager/staff
and the QA person, competent authority....logistics versus
QA/regulatory. Though it is typical a pharmacists' interest to reconcile
these interests for medicine supply at country level.
A trace to a particular manufacturing site is specifically useful in
cases where a manufacturer operates multiple sites. In particular where
one site is approved by local authorities and another site is licensed
as well by the local DR but also found to be compliant by an external
organization or an importing country and the first one is not or not yet
assessed. Alternatively in situations where production is outsourced or
packaging is done elsewhere than production. Any 'reworked batch',
another point in case, usually originating from a campaign (series of
batches) manufactured in the same month (hence often same expiry
dating!) also needs according to GMP to be issued with a new batch
number. In addition, product codes and batch numbers could be linked in
your system to standard/validated batch sizes (order quantity fresh
batch, avoid being supplied with small left-overs over different batches
etc.), stability studies and regulatory change controls like dossier
variations.
As said above it depends on your perspective: logistics or
quality/regulatory.
Recalls are among other related to mix-up in packaging lines,
contaminations or errors during production which were not detected (or
investigated) prior to or as part of the batch release. Depending on
one's perspective, but in my view batch numbers are essential in the
supply chain:
1) import/release batches based on QC / stability studies and GMP
status of the specific MF site
2) provide traceability of final product formulations to starting
material lots used, intermediate steps or deviations which may have
happened during production
3) maintain track of batches and to address any product complaint from
the field.
GDP would mostly refer to the latter (3), whereas (1) and (2) could be
more GMP like. On shelf locations: couldn't one use simple dividers
between batch numbers not to unnecessarily expand the storage space?
It is true that in a urgent recall situation it is better to alert a few
more rather than a few too less. Yet I wouldn't agree that contacting
customers with expiry dates only asking them to find the possibly
associated batch numbers is good practice (here at the moment supreme
they may also misread a number easily?) nor could it be a minor
imperfection. Guess I am one of the batch number advocates...!
How this translates best into practice not to overburden admin systems
without dressing up the emperor and at the same time to rule out missing
a full reconciliation in one of the 'only sporadic recalls' is in my
view a rhetorical question.
Pascal Verhoeven
Pharmacist/Independent consultant
verhoeven.pascal@gmail.com