Printed Packaging Material Suppliers to Pharmaceutical Companies

D

dissertation

#1
I am carrying out a study on printed packaging material supplying pharmaceutical companies (leaflets, cartons, labels). The aim is to design a pre-audit questionnaire to printed packaging material suppliers. Do you have any ideas of what it can include?

Thanks
 
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Ajit Basrur

Staff member
Admin
#2
I am carrying out a study on printed packaging material supplying pharmaceutical companies (leaflets, cartons, labels). The aim is to design a pre-audit questionnaire to printed packaging material suppliers. Do you have any ideas of what it can include?

Thanks
Welcome to the Cove :bigwave:

I have moved your question to the Pharmaceuticals section to get more responses.

I feel a good starting point for your question would be ISO 15378.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
I am carrying out a study on printed packaging material supplying pharmaceutical companies (leaflets, cartons, labels). The aim is to design a pre-audit questionnaire to printed packaging material suppliers. Do you have any ideas of what it can include?

Thanks
Hello dissertation. Welcome to the cove.

I'm the Quality Systems Manager for exactly such a company. We make labels, cartons, outserts, booklets, and flexible packaging at multiple sites.

From what perspective is this questionaire coming? From a pharma company's supplier quality group?
 
D

dissertation

#4
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
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
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.
 
T

tamale

#6
Here is a technical document from the governement printing office that will help you pinpoint the technical issues as opposed to the system ones.

It might be availlable in a more recent version.

The attributes are still very valid and will help you formulate specific audit quastions.

In printing things don't change except with prepress. prepress is an area that is in constant evolution.

Hope it helps!

Tamale
 

Attachments

D

dissertation

#7
Thank you so much for all your help. I really appreciate it... I would like to ask you an other question. Do you know the difference between ISO9001:2008 and ISO15378?

If i had to ask a question, which one would you choose:
Are you certified for ISO 9001:2008
or
Are you certified for ISO15378?

Thanks a million
 
D

dissertation

#8
A question to ScottK what is automated vision inspection system? thanks for all your help
 

Stijloor

Staff member
Super Moderator
#9
Thank you so much for all your help. I really appreciate it... I would like to ask you an other question. Do you know the difference between ISO9001:2008 and ISO15378?

If i had to ask a question, which one would you choose:
Are you certified for ISO 9001:2008
or
Are you certified for ISO15378?

Thanks a million
This may help.

Certification to either standard may depend on what your customer(s) require(s).

Stijloor.
 
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