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GMP Training – GMP for Warehouse by www.gmpsop.com
Step 1: Defective product in the market
In the event of a recall, QA will agree with the regulators on the scope of the
recall before the recall is triggered. The recall decision will usually happen very
quickly, so the warehouse must be recall-ready at all times. The company should
assess the quantity of stock in the marketplace at this time, with the aim of
recovering 100% of available stock.
Step 2: Recall notice Issued
The recall notice will state that the recall must occur at a particular level in the
marketplace. Class I recalls occur at the consumer level; Class II or III recalls
may occur at the retail or warehouse level. For consumer level recalls, there is
usually a company hotline to assist customers.
Step 3: Return to company locations
Defective product will be collected at nominated warehouses. It is progressively
checked, counted, and the returns recorded in a recall register. As the recall
progresses, the percentage of defective stock is monitored. The recall is
continued until 100% is returned, if possible.
Step 4: Move to dedicated Recall store
The detective product is eventually gathered in one central location in a separate,
secure Recall store or location. The recalled material must never end up in the
main warehouse.
Step 5: Destruction
Once the recalled product has been secured, it should be securely destroyed so
that there is no possibility it ends up back in the marketplace. Companies should
have secure destruction procedures, and the physical destruction should be
witnessed or otherwise verified.
Counterfeit products
Unfortunately, it has become prevalent for counterfeit medicines to make their
way into the distribution chain. Many of these products look almost identical to
the original products, both in drug appearance and packaging, These counterfeit
products contain no active ingredients (APIs), and can be dangerous to patient
health if consumed. They may even contain poisons.
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