Packaging cartons

Hello Everyone ,

I want to know "What the regulation (EU,US)we have for secondary packaging materials ( Printed Cartons) we need to follow as a carton box manufacturer.

Dear Gayathri
Could you please explain in detail your question.
Are you a manufacturer ? or a pharmaceutical company buying Printed Cartons.
If you are manufacturer the specification should be given by the buyer (customer) … as such there is no special regulation .


Dear Mr.Jay,

We are carton box Manufacturer & I want to Know what are the International Standards and Guidelines we should follow for secondary packaging.

Dear Ms. Gayathri,

Pharmaceutical packaging is critical part of the medicine so it has to be a standard quality.
Please refer following WHO guidelines for the requirement:
Annex 9: Guidelines on packaging for pharmaceutical products
For the quality and manufacturing of carton please refer following ISO standard:
ISO 15378:2015(en)
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)