Packaging cartons

Regulatory
1

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.

2

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 .

Regards
Jay

3

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.

4

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)