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GMP Training – GMP for Warehouse by www.gmpsop.com
The Released label indicates the material is suitable
for use or released for supply. The batch has been
tested and cleared by the Quality Department.
The Approved label indicates the material is
suitable for use or released for supply. The batch
has been tested and cleared by the laboratory.
The Rejected label indicates that the batch has been
assessed as unacceptable or defective. Never use
these materials. They should be located in separate,
locked area.
Control of product labels
The control of product labels is a crucial port of GMP, since customers may be
adversely affected by mislabeled product. All product labels must therefore be
strictly controlled. Some of these controls include:
Each different type of label is clearly identified and segregated in the label
store to prevent mix-ups.
Access to the label store must be restricted to authorized personnel.
There should be no loose approved or released labels in the store.
Any unused or damaged labels should be returned to the Quality Department.
"Approved" or "Released" labels should only be issued by the Quality
Department.
Before the release of labels, they must be checked and double-checked
against the work order to verify the:
- product name and code
- label identity and version number
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