Hi,

Our management has decided to go in for the ISO 15378 certification. Has anyone experience with this standard ?

How many procedures / records are required - does any one have this information ?

:thanx:

Can't help there :(

Have you made a GAP analysis? Perhaps you should contact your Notifying Body and have them assist you? :bigwave:

Can't help there :(

Have you made a GAP analysis? Perhaps you should contact your Notifying Body and have them assist you? :bigwave:

Thanks Gert.

Have just prepared a template for doing gap analysis. Btw, our Notifying Body in Hong Kong is also new to this standard and they are contacting their corporate office for more details. In between all this time consuming exercise, I was thinking of getting help from cove. ;)

Let's hope someone from Pharma will pop by today and give their :2cents:

This is interesting, we provide packaging materials to many pharma companies, but have never been asked about this standard, never mind certification. I'll have to get a copy and see what I'm missing.