Quality Manual sample needed (pharmacovigilance)

Hi all,

I just joined this site yesterday and it seems to be a pretty helpful and friendly site. My company works in the area of pharmacovigilance and I'm looking for some samples/examples of a quality manual, preferably in the area of pharmacovigilance. Or a quality manual of a company which offers services, not products. Should it be essentially a copy of the ISO9001:2000 manual, suitably modified?

Hi, I don't have a copy of a manual in pharmacovigilance (I'm actually having trouble pronouncing that!) but I would recommend you start by looking through the newest standard 9001: 2008

If you look in the attachments (green box at the top of this page, just to the right of the lighthouse) you can search for all manner of quality manuals from lots of different industries.

Here are quite a few quality manual examples. As Colpart noted, however, there probably isn't a pharmacovigilance manual. Hopefully someone will have one to share.

And don't forget the "free files directory".

There's a manual for pharmaceutical company attached to this post. Not sure if it is nearer to what you want.

Thanks guys!

Hi all,

please, does anyone have a pharmacovigilance quality manual sample or pharmacovigilance standard operative procedures?

https://www.ich.org/fileadmin/Publi...idelines/Efficacy/E2E/Step4/E2E_Guideline.pdf

https://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9_10-2004_en.pdf

Thank you for your reply but a new pharmacovigilance legislation is in force in EU and a new QMS for Pharmcovigilance is required.
So, If someone has a sample according to the new requirements, I will be very very grateful.

A quick "Bump". Does anyone here have any information of the latest pharmacovigilance legislation?