ECA issues a revision to the EU Guide Volume 4 Annex 15: Qualification and Validation

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The ECA has issued a revision to the EU Guide Volume 4 Annex 15: Qualification and Validation which addresses Verification of Transportation for drug products.

The guideline recommends that a risk assessment be performed to consider the impact of conditions other than temperature that the product experiences during transportation.

Here is an excerpt (page 11 of the draft revision):

VERIFICATION OF TRANSPORTATION

5.1 Finished medicinal products, investigational medicinal products, bulk product and samples should be transported in accordance with the conditions defined in the Marketing Authorisation, product specification file or by the manufacturer.

5.2 It is recognised that validation of transportation may be challenging due to the variable factors involved however transportation routes should be clearly defined. For transport across continents seasonal variations should also be considered.

5.3 A risk assessment should be performed to consider the impact of conditions other than temperature during transportation e.g. humidity, vibration, handling, delays during transportation, failure of data-loggers, topping up liquid Nitrogen, product susceptibility and any other relevant factors.

5.4 Due to the variable conditions expected during transport e.g. delays at airports, continuous monitoring of any critical environmental conditions to which the product may be subjected should be performed.

Get the full document here.

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