Page 47 - GMP for warehouse

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

Release to Quarantine
After manufacturing, the Packaging Department checks that all the batch
documentation is complete and accurate, and the product has been correctly

packaged and labeled.

The batch is then assigned to the Quarantine area in the warehouse.

QA clearance
GMP rules require that Quality Assurance conduct a final audit or clearance of
the manufacturing and packaging records. This is to independently verify that
the product has been correctly manufactured, packaged and tested.

If there are any questions or unresolved issues with a batch, QA will hold up

release of the batch until these remaining issues are closed out.

Preparation for dispatch
The warehouse team will receive a picking or dispatch order for either the whole
batch or for smaller portions of the batch. At this time, it is critical to cross-
check the order against the batch details. If any batch still in the Quarantine
store is picked, supervision should be notified immediately.

Prior to shipment, the order must be protected from possible transport damage
or deterioration (e.g. addition of outer packaging, shrink wrap of pallets, labeling
of transport temperature conditions).

Preparation for transport
After QA has officially released the finished batch, it may be moved from the
Quarantine to Released store (and labeled as such), making it ready for dispatch
to other warehouses, hospitals, distributors, or retail outlets.

Transport

The quality of the product can be affected by incorrect transport. The product
may be damaged if it is not protected from rough handling or adverse
temperature conditions. Some product may also be sensitive to vibration,
changes in atmospheric pressure, or freezing or thawing.

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 47 of 64