Pilot stability batch shipping control

GOOD VALIDATION PRACTICE (cGVP)
1

Greeting!

We are purchased of the stability pilot batch (medical device – ophthalmic solution) from Germeny and it needs to ship out via sea to Asia.

Question:

  1. Is there a requirement to control the shipping environment i.e Temperature, humidity?
  2. Is there any guidance for the shipping of stability study batch?

Thank You

2

There are Good Distribution Practices requirements for shipment or consignment to ensure product quality doesn’t deteriorate over shipping period. Therefore, if the ophthalmic solution is sensitive towards temperature or humidity, it requires some controls in place to ensure its quality. You may log in link below to understand more about GDP and devise controls and monitoring protocol for the batch.

http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/gmp/files_1.Par.84852.File.dat/GUIDE-MQA-013-009.pdf

3

[quote=tangkakj]There are Good Distribution Practices requirements for shipment or consignment to ensure product quality doesn’t deteriorate over shipping period. Therefore, if the ophthalmic solution is sensitive towards temperature or humidity, it requires some controls in place to ensure its quality. You may log in link below to understand more about GDP and devise controls and monitoring protocol for the batch.

http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/gmp/files_1.Par.84852.File.dat/GUIDE-MQA-013-009.pdf
[/quote]

Thanks for your advice.

The product is not sensitive towards temperature and humidity. Our main concerned is, these is the Stability batches. Auditor might challenge us on this.

Anyway, the temperature and humidity is monitored during the shipment.

Regards:D

4

If that’s the case, you may monitor stability of the products by storing them in the oven with simulated shippipng temperature and humidity. Document monitoring results and I believe you may demonstrate stability of batches whenever queried by auditors.

Good luck!