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The PQG (Pharmaceutical Quality Group) series of standards: PS 9000: 2001

QMS for Medical Device Companies
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H

harry

Super Moderator
#2
#2
Re: Ps 9000:2001

This is what I found through google,

The Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance (IQA) has developed PS 9000:2001. It aims to provide a widely accepted baseline GMP framework of best practice within the pharmaceutical packaging supply industry. It applies ISO 9001: 2000 to pharmaceutical printed and contact packaging materials.

PS 9000:2001 is based on and replaces the two separate IQA/PQG Pharmaceutical Supplier Codes of Practice (CoP) for contact and printed packaging materials. These Codes of Practice were first issued in 1990 and subsequently revised in 1995. The CoP successfully established a widely accepted baseline GMP framework for suppliers of contact packaging and printed materials. They also formed the basis for a certification scheme that enables suppliers to publicise compliance with the requirements of a specific CoP.
Click to expand...
More through this CQI link.

Some previous discussions on PS 9000.

Also, this post by Sidney.
 
Last edited:
B

BSeymourH

#3
#3
Re: PS 9000:2001

Thanks for the quick response.

I was asked to audit ISO9001:2008 for a box manufacturer and printer

At the start of the pre-audit audit, I quickly discovered that it was a combined ISO9001 and PS9000 projecr and I , of course, am not qualified to audit the PS standard.

My problem is that I can't find anyone who is and I feel that that might be because PS9000:2001 must be superceded by BRC/IoP

Bryan
 
H

harry

Super Moderator
#4
#4
My problem is that I can't find anyone who is and I feel that that might be because PS9000:2001 must be superceded by BRC/IoP
Click to expand...
If you follow FDA guidelines, they (pharma versus food) are different although quite similar. I think it is the same elsewhere and BRC/IoP is for food only.

We have a number of Covers from the pharma industry and they should be able to throw some light on this.
 
B

BSeymourH

#5
#5
Hi

Version 3 of BRC/IoP defines category 1 packaging as:-

Packaging that comes into direct contact with high risk products

High risk products are defined as:-

Those products intended for human consumption or which come into close conact with the body such as application to the skin or are intended for infants

Appendix 2 Fields of Audit for Packaging and Packaging Materials; board cartons appear in the paper section

Therefore, it seems that BRC/IoP would be the preferred standard

Bryan
 
Ajit Basrur

Ajit Basrur

Staff member
Admin
#6
#6
Yeah, there are 2 standards from PQG viz.

PS 9000 for Pharmaceutical Packaging Materials, and
PS 9100 for the Pharmaceutical Excipients

Both these standards include ISO 9001 requirements, but additionally contain the specific pharmaceutical industry requirements therefore if you want to combine ISO 9001 with PS 9000, that could be easily done.

Btw, an equivalent of PS 9000 would be ISO 15378 that was discussed earlier at http://elsmar.com/Forums/showthread.php?t=20353
 
B

BSeymourH

#7
#7
Hi Ajit

Thanks for the quick response.

I need to find a qualified PS9000 auditor in the UK, and I'm not having much luck


Bryan
 
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