Page 53 - GMP for warehouse

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

GMP rules require that all returns be examined by the Quality Department and
if necessary re-tested, before they can be placed back into stock. In some cases,
if there is no way to tell if returned products have degraded, they must be
destroyed.

Products earmarked to be reissued must be kept separate from the rest of the
stock until they are investigated. They may be returned to stock, only if the
goods:

are in their original containers, unopened, and in good condition

are known to have been handled and stored correctly

have an acceptable shelf-life remaining

have been assessed by the appropriate, authorized personnel

Records must be kept of these returns, and if they are returned to stock, FIFO
must continue to be observed. Medicines that are unfit for sale must be stored
separately, and disposed of in a secure method (e.g. incineration).

GOOD TO KNOW - ASSESSING CUSTOMER RETURNS

The assessment of customer returns should take into account the nature of

the goods, and any special storage conditions they may require. If necessary,
advice should be sought from the person responsible for the quality assurance
of the manufactured product.

Considerations for handling the return of non-defective stock include:

Place a limit on the return period (e.g., 3-5 days from customer receipt).

No returns of "fridge lines".

Communicate the company's policy to customers,

Use a clear returns document that requires customers to include the
product's batch number and expiry date.

Have detailed procedures on how to handle, locate and identify returns.

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