GMPs for APIs - Active Pharmaceutical Ingredients Committee - Cefic

"How to do"-Document Page 36 of 70
9.3 For the API industry, computer printed labels are a norm and pre-printed labels are
exceptions. Most of the ICH statements addressed pre-printed labels. Computer
printed labels are typically printed “on demand” basis and little or no storage is
needed.
9.30 Applicable only for pre-printed labels or labels that are printed by on site computer
and stored.
For labels printed “on demand” blank roles of label are not applicable.
9.31 The main focus is on pre-printed labels or labels that are printed by on site computer
and stored.
For labels printed on demand also procedures should be in place to check “number of
labels demanded”, “number of labels printed”, number of labels put on the drums”,
“number of labels attached to the batch record or other traceable documents, e.g.
shipping / dispensing documents” , “number of labels destroyed”.
Additionally a check that the label(s) conform to the master should be documented in
the batch record or other dispensing records. (See also chapter 6.52 for reference).
Discrepancies referred to should be treated as critical deviations and thus the results of
the investigation should be approved by the Quality Unit and include measures to be
taken to prevent reoccurrence.
9.32 See comments 9.31, returned labels are not likely to occur if “on demand” printed labels
are used. If too much labels have been demanded, they should be destroyed and
this activity should be documented in the batch record.
9.33 –
9.34 Programmable printing devices used to print labels on demand should not be subject to
validation.
Printing devices may be controlled by a template, which may be changed by designated
personnel according to an established procedure(s).
9.35 The examination of printed labels regarding proper identity and conformity with a
master should be documented in the batch record or other documentation systems in
place, e.g. dispensing records.
(see 9.44, examination and documentation of packaging and labelling).
9.36 See 9.31 for reference.
9.4 Packaging and Labelling Operations
9.40 Additionally to primary packaging and labelling after completion of production relabelling
with customer specific information as part of manufacture / dispensing /
shipment is common practice. These activities have to be documented in the batch
record or other systems in place, e.g. dispensing records.
9.41 One labelling operation at the same time, only one batch to be labelled (not to be interpretated
as stored) on one pallet or in a defined area (spacially separated). Also barcode
systems correlating batches to labels could be used to prevent mix-ups.
Version 4 September 2002