Page 17 - Packaging Controls

GMP Training – Packaging Controls by www.gmpsop.com

Some organizations will not return printed matter
to the store, because of the potential to mix up the

returned item.
RETURN TO
STORE It is a GMP regulation that coded printed matter is

never returned to the store for reuse. The reasons
for this should be apparent, as coding is always
unique to a batch.

In a busy packing hall, there are generally many products being processed at
once. Unless there are specific GMP controls in place, it is inevitable that a rogue
item of printed matter will eventually end up on a different product. This may
not get detected later, and could injure patients and cause a recall. Proper line
segregation helps to physically separate different printed matter, much of which
looks similar.

A combination of physical segregation, double line checks when new printed
matter arrives, and detailed line clearances are critical GMP labelling controls.

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:

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