Page 33 - Packaging Controls
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GMP Training – Packaging Controls by www.gmpsop.com
data. Such discrepancies shall be investigated in accordance with 211.192.
Labeling reconciliation is waived for cut or roll labeling if a 100-percent
examination for correct labeling is performed in accordance with 211.122(g)(2).
International GMPs
Chapter 5 Production
Packaging operations (extract)
5.56 Any significant or unusual discrepancy observed during reconciliation of
the amount of bulk product and printed packaging materials and the number of
units produced should be investigated and satisfactorily accounted for before
release.
5.57 Upon completion of a packaging operation, any unused batch-coded
packaging materials should be destroyed and the destruction recorded. A
documented procedure should be followed if uncoded printed materials are
returned to stock.
Overview
In a reconciliation, the quantify issued to (a known or verified count) should be
compared with the sum of:
the quantity used for good product
the quantity used for rejected product
the quantity used for samples
the quantity used on documentation
the quantity damaged
the quantity returned
Every single measure is a count, not a calculation.
An unsatisfactory reconciliation can indicate loss of material, a gain of foreign
material, a miscounting, or bad arithmetic.
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