Page 27 - Packaging Controls
P. 27
GMP Training – Packaging Controls by www.gmpsop.com
The manufacturer, packager, or distributor
The manufacturing batch number
The expiration date
Standard dosage requirements
Frequency of dose
National Drug Code (product distributed in the
US market)
Additional national requirements, if any
Storage statement
Declaration of net quantity of contents (count,
weight, measure etc)
Precautions to observe if there are
incompatibilities with other medical conditions
or products, as well as awareness of possible
side effects
Package inserts, patient information leaflets
Mix up risks and prevention:
Defects related to packaging, labels and leaflets are
the most common reasons for recalls. Thus it is
important to identify risks for mix-up during
packaging and label operations and to ensure there
are appropriate procedures in place for mix-up
prevention.
Mix-ups may occur if personnel are not aware of the
risk, if layout of premises or procedures are not
adequate. The following should be reviewed and or
considered:
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