Page 45 - GMP for warehouse

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

GOOD TO KNOW - MONITORING STORED MATERIALS

Starting materials should be retested or re-examined after long storage or after
exposure to adverse conditions. Stored starting materials may not be used for
extended periods. If stored correctly, under controlled temperature conditions
they will be good through to expiry date.

Sometimes, the laboratory will want to retest materials before continuing use.
This is usually a precaution for materials that could, for example, pick up
moisture on storage.

Rejecting defective and expired materials

Starting materials and packaging materials may not meet qualify standards on
receipt, or may reach their use-by date ("time expire") during storage. GMP rules
require that there are written procedures for the handling and rejection of
materials that are defective or have time-expired.

GOOD TO KNOW - EXPIRING STARTING MATERIALS

It is not uncommon for starting materials and finished products to reach their
use-by date. Many companies have specific rules about only releasing finished
product that has, for example, over 50% of its shelf life remaining, because
customers may reject it as having too short a shelf life.

Companies also have rules regarding the receipt of "short-dated" starting

materials. Management should be alerted if incoming goods have, for example,
less than 75% of their expiry period left, Check your company procedures
regarding this policy. GMP rules then require that the expired stock be securely
disposed of, so that there is no chance it finds its way back into manufacturing
or onto the market. There should be specific secure disposal procedures in
place to control this activity.

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