Thanks to both for your reply.
The pre-audit questionnaire can be used by the pharma company to inspect supplier companies to estimate level of good practice. So basically, apart from good practice, I am looking at risk areas and post issues (complaints, recalls, rejectioins) which happen at supplier company to make the questionnaire more specific and and get a better estimate.
Thanks
well - keep in mind that you have to ask questions that suppliers will actually answer.
Questions about complaints and rejections are likely not to be answered except in the vaguest of terms. I mean, I don't volunteer how many total rejections we've had for a given time period on a form or questionaire. That's something to go over in a face-to-face audit.
I will say that we have a documented complaint system that complies with ISO9001 and ISO13485 and can give details on complaints we've answered with the company you are representing.
Something to keep firmly in mind while you write this is that, in the USA anyway, Secondary Packaging is not subject to FDA inspection so while many of us comply with cGMP's to the extent that it makes sense for us, we are not registered and don't have to be.
Things to definately ask about:
- Validation of processes that are not verified by later inspection. This is particluraly important in the pre-press area if the company does computer-to-plate and for automated vision inspection systems.
- Lot control of substrate, inks, coatings
- Training - very very important for people that inspect finished product. There are customers that require 100% inspection and a lot roll product is inspected under a strobe system (like a Rotoflex). To operate one of these properly takes a lot of training.
-Supplier qualification.
I have to get back to work - but that's a start...
I hope you share your questionairre with me when you're done!

I could use it for internal audits.