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  • Submitted: May 08 2011 09:39 AM
  • Last Updated: May 08 2011 09:39 AM
  • File Size: 2.12MB
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Download A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packaging Materials

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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

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