Transport Validation: new Considerations by Annex 15

Recommendation

7/8 May 2024

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The European Commission has launched the long expected draft of the revised Annex 15 (Qualification and Validation) for public consultation (see our GMP News from 12 February). This revision mainly takes into account changes to other sections of the EU-GMP Guide Part I, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation and changes in manufacturing technology. But also a new chapter on verification of transportation has been included.

Along with the Guidelines on Good Distribution Practice of Medicinal Products for Human Use (GDP Guideline), transport should be performed  in accordance with the conditions defined in the Marketing Authorisation (normally these are the storage conditions), the product specification file (for investigational medicinal products) or by the manufacturer. Those could be defined based on product stability and risk assessment. The chapter also defines that risk assessment should not be limited to temperature impact but also to other factors like "e.g. humidity, vibration, handling, delays during transportation, failure of data-loggers, topping up liquid Nitrogen, product susceptibility and any other relevant factors." Any critical environmental conditions should be continuously monitored throughout the transport.

Stakeholders are invited to comment on this draft by 31 May 2014 at the latest.