Hi Validation Expers
I have a question for you.
Currently we are doing a project for a Manufacturing Distribution Company.
They basically distribute products to different Pharma companies around Ireland.
We are currently auditing their system, and we have noticed that they have performed
no Part 11 testing to any degree.
My question is if they company is only distributing product around Ireland, does Part 11 apply
to their warehouse computer system, and should the validation have included this.
Regards
Since Irish Medicine agency comes under EMEA (EU zone) Annex-11 is applicable. You can also looks PIC/s guidance too for this sake if it is applicable.
Hi,
Yes, regulations of business market as well as local authorities are applicable for all i.e. Manufacturing, packaging, labelling, distribution, Marketing, stockist / Warehousing.
Same is applicable there also.
Happy Reading !
Hi Mr. Gokeeffe,
Can be activate the translate option in the forum ? …so the reply posts also useful to other readers.
[quote=siddhipharma]Hi Mr. Gokeeffe,
Can be activate the translate option in the forum ? …so the reply posts also useful to other readers.[/quote]
Oops this is spam siddhipharma, I will delete now!
Sometimes it gets through and we cannot stop it!
Sorry!