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A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packa


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#1 Simon

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Posted 08 May 2011 - 09:39 AM

File Name: A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packaging Materials
File Submitter: Simon
File Submitted: 08 May 2011
File Category: Guidance Documents

This PS 9004 guide is copyright protected by IQA/Pharmaceutical Quality Group(PQG). This guide aims to assist suppliers of pharmaceutical packaging materials to understand and implement the Quality Management System (QMS) of ISO 9001 and the application standard of PS 9000. It supplements the following documents:

• ISO 9001 which specifies the requirements of the international QMS standard
• ISO 9004 gives guidance on ISO 9001
• PS 9000 is an application standard written by the PQG for suppliers of pharmaceutical packaging materials that integrates ISO 9001 and ISO 9004 together with additional Good Manufacturing Practices (GMP) requirements particular to these suppliers

Companies complying with PS 9000 will comply with ISO 9001 and also the additional GMP requirements endorsed by the highly regulated pharmaceutical industry

Click here to download this file

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#2 saguym

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Posted 08 May 2011 - 11:24 PM

File Name: A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packaging Materials
File Submitter: Simon
File Submitted: 08 May 2011
File Category: Guidance Documents

This PS 9004 guide is copyright protected by IQA/Pharmaceutical Quality Group(PQG). This guide aims to assist suppliers of pharmaceutical packaging materials to understand and implement the Quality Management System (QMS) of ISO 9001 and the application standard of PS 9000. It supplements the following documents:

• ISO 9001 which specifies the requirements of the international QMS standard
• ISO 9004 gives guidance on ISO 9001
• PS 9000 is an application standard written by the PQG for suppliers of pharmaceutical packaging materials that integrates ISO 9001 and ISO 9004 together with additional Good Manufacturing Practices (GMP) requirements particular to these suppliers

Companies complying with PS 9000 will comply with ISO 9001 and also the additional GMP requirements endorsed by the highly regulated pharmaceutical industry

Click here to download this file


Simon,
As far as I know the ISO 15378 (2006), is actually the GMP requirments for primary packaging materials for medicinal products, with particular requirments for the application of ISO 9001.
Are ther any links between PS 9000 and ISO 15378 ?

saguym




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