Page 8 - Packaging Controls
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GMP Training – Packaging Controls by www.gmpsop.com
investigation of reconciliation discrepancies
destruction or return of unused material
Many mislabeling incidents commence with the wrong issue of labels or other
printed matter from the store.
The GMP rules clearly state that each issue of printed matter from the store must
be accompanied by requisition paperwork and that there is a cross-check that
labels match the documented request before issue.
The reason for this is the issue is the first point of control. It is much better to
prevent incorrect labels being issued in the first place rather than finding them
(or not) later on. Mislabeling can cause incorrect consumption or patient
medication, which can result in serious injury or even death of patients.
What do the GMP rules say?
US FDA CFR 211
Sec. 211.130 Packaging and labeling operations. (extract)
There shall be written procedures designed to assure that correct labels, labeling,
and packaging materials are used for drug products; such written procedures
shall be followed. These procedures shall incorporate the following features:
(a) Prevention of mixups and cross-contamination by physical or spatial
separation from operations on other drug products.
(d) Examination of packaging and labeling materials for suitability and
correctness before packaging operations, and documentation of such
examination in the batch production record.
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