PS 9000 - PS 9004 & PS 9100 Pharmaceutical vs. ISO 13485-2003 and ISO 9001-2000

[Ray cooke]

Does anyone out there understand the requirements of the above Standards?
We are a medical device manufcturer who is increasing scope to include supplie of constituent parts to the Pharma industry and have been advised by our notified body that this is the way forward we are already certified to 13485-2003 and 9001-2000,what are the differences?
is there a Gap analysis readily available?

[Al Rosen]

In Reply to Parent Post by Ray cooke

Does anyone out there understand the requirements of the above Standards?
We are a medical device manufcturer who is increasing scope to include supplie of constituent parts to the Pharma industry and have been advised by our notified body that this is the way forward we are already certified to 13485-2003 and 9001-2000,what are the differences?
is there a Gap analysis readily available?

You can find more information and purchase the standards here.

[Marc]

For those not in the know:

The PQG (Pharmaceutical Quality Group) series of standards: PS 9000, PS 9100 and PS 9004

The PQG, together with many expert professionals in the industry and volunteers with many years experience, are proud to publish a series of globally acclaimed standards, the PS 9000 series.

PS 9000:2001 is an application standard developed by the PQG for the manufacture of packaging materials for medicinal products. The document defines specific requirements and guidance for GMP integrated with ISO 9001.

PS 9004

PS 9004 Pharmaceutical Packaging Materials - A Guide to PS 9000.

The guide provides in clear language, the appropriate reason for each critical requirement contained in PS9000:2001 together with details of sources of further useful reference information. The guide is intended primarily to help with the education and training of supplier's staff but will also be useful for the training of appropriate pharmaceutical industry staff.

PS 9100

PS 9100:2002 is an application standard developed by the PQG for the manufacture of excipients for medicinal products. This code of practice defines specific requirements and guidance for GMP integrated with ISO 9001.