Page 31 - Packaging Controls
P. 31
GMP Training – Packaging Controls by www.gmpsop.com
procedures. All cut labels must be stored and
transported in a secured container.
Controls used for routine labeling activities include:
Use of appropriate electronic or
electromechanical equipment to conduct a
100% examination for correct labeling during or
after completion of finishing operations.
Use of a visual inspection to conduct a 100%
examination for correct labeling during or after
completion of finishing operations or hand-
applied labeling. Such examination must be
performed by one person and independently
verified by a second person.
Monitoring of printing devices on, or associated
with, manufacturing lines used to imprint
labeling upon the drug product unit label or
case to assure that all imprinting conforms to
the print specified in the batch production
record.
Documentation
The appropriate SOPs and packaging batch records
must be followed when documenting any other
information associated with packaging or labeling.
Other pertinent types of documentation include
records of:
who has set up a particular machine
how they have done it
adjustments or repairs
second checks
Batch and/or packaging documentation must
include:
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