Page 27 - GMP for warehouse

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

This area is also the first point where outer bags and cartons are cleaned down,
so that minimal dirt is transferred to the warehouse itself. If goods are unclean
or damaged, they should not be sent into the warehouse.

Warehouse
The warehouse itself is not pressure-controlled, but is cleaner than the receipt
area. In the warehouse, goods should be stored off the floors and away from
walls, because moisture may be taken up through concrete walls and floors. This

area is sometimes referred to as a "grey" zone since it is cleaner than outside,
but still not clean enough to expose products to the environment.

Production Area
Some companies refer to the production area as a "white" or "clean" zone, where
only cleaned materials may be taken. Generally, goods transported to this area
are on plastic pallets, since wooden pallets cannot be cleaned and can harbor

fungus, mould, and bacterial contamination. The production zone is pressure-
controlled to provide an air barrier to dirt and particles entry. In order to
maintain positive pressure, it is critical to keep the doors between the production
and warehouse areas closed.

Before materials are taken into the production area, the outer cartons that had
arrived on the truck are generally removed, where possible, as an added
precaution. Most companies also have different dress codes when moving from
a grey zone to a white zone.

Importance of storage temperature controls

Temperature storage controls are important in the warehouse in order to ensure
product integrity throughout the product's shelf life. Medicinal products
damaged by exposure to extremes of temperature may escape detection,
resulting in physical damage and/or loss of therapeutic effect. Worst of all, it
may not be obvious at all.

For temperature-controlled warehouses, companies are expected to create a
temperature map of the facility. The map is used to identify the best places in
the warehouse to store goods. An initial study when creating this map will reveal

Copyright©www.gmpsop.com. All rights reserved
Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
Page 27 of 64