Page 54 - GMP for warehouse

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

Ensure warehouse staff are trained to the returns procedure and how to
separate each return.

Ensure the returns procedure includes a detailed physical inspection, and
if necessary, a laboratory test to verify that the goods are "safe" to re-issue.

Maintain a product returns register showing dates, batch numbers,
amounts and condition of the return. This register is needed for later
investigation if there is a problem.

Managing recalls

It's almost inevitable that a company will experience a recall at some point. GMP
rules require that the warehouse (and the company) is prepared by having a
tested or validated recall procedure, which details how defective stock is
returned, registered, counted, securely separated, and securely destroyed.

GOOD TO KNOW – MANAGING RECALLS

Recalls must be very carefully managed by manufacturers in order to protect

patients and end-users. Risks surrounding recalls include:

the right people not being notified

the recalls not dealt with in a timely manner

recalled product re-entering the supply chain

The last point shows the pivotal role the warehouse plays during a recall
situation,

Warehouses should have a separate area for recalled stock where recalls from
customers are sent to the manufacturer.

Critical to a successful recall is complete and up-to-date documentation
showing where each and every part of the recalled product can be located,
either within the distribution chain or with customers.

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 54 of 64