Page 41 - GMP for warehouse

GMP Training – GMP for Warehouse by www.gmpsop.com

Only in rare circumstances should quarantined materials be used in production.
If this is to happen, there must be very strict controls in place in case of a recall.

Receiving printed matter

When dealing with starting materials, direct control over product quality begins
when the starting materials first arrive at the inward goods receiving boy.

The same principles apply when printed matter arrives at the manufacturer.

Inward goods must ensure that the right printed matter is received, so that the
correct printed matter is eventually released to the packaging area. When the
printed matter arrives from the printers, it must be given its own UIN, and then
be placed into quarantine.

Following receipt and quarantine, printed matter is examined and verified by QC
against standard specimens and specifications, in order to avoid any mix-ups or
errors. Since many labels, cartons, and leaflets look alike, it is important that
QC personnel take particular care in both sampling and testing. Packaging and
labeling samples should not be returned to inventory.

Only after printed materials have passed inspection should they be released for
use.

GOOD TO KNOW - SAMPLING PLANS FOR PRINTED MATERIAL

Sampling plans are used by QC in order to specify the number of samples of
printed matter to be taken. There are several types of sampling plans QC use,

e.g. statistical, targeted, and zero acceptance number Although QC use all of
them for printed matter in some respects, the reasons why each are chosen is
beyond the scope of this module.

Suffice it to say, sampling plans for printed matter account for at least the
following:

the quantity and quality of printed matter received

the quality of printed matter required

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