Suppliers

These standards are of particular interest to management and supervisory personnel engaged in the manufacture and supply of excipients and packing materials, especially where they are involved in the training and education of staff.

The current list of certified suppliers.

The current list of certified certification bodies that suppliers need to contact to gain certification.

An overview of the process to gain certification.

QA auditors

The pharmaceutical industry will also find them valuable in helping to assure that they assess their suppliers to a recognised standard.

For more information on PS 9000 series use the following links:

PS 9000
PS 9004
PS 9100

Certification to become a PS 9000 series auditor requires you to satisfy certain criteria. If you are interested in becoming a PS 9000 series auditor, first have a look at PQG 602 to see what is required and then click here to download the Application Form. When the form and details are complete, return the application form as detailed on it to become an auditor.

For more information download the following PDF document:

PQG 602 document PDF (118Kb)

 

Current PS Auditors need to keep their details up to date to make sure that your name appears on the PQG list of certified auditors.

The current list of certified auditors.

For more information download the following PDF document:

PS 9000 series auditor questionnaire PDF (101Kb)

Auditor Training

Organisations looking to offer training for PS 9000 series auditors need to meet the requirements of IRCA 2235.

The current list of organisations offering training for auditors.

For more information go to the IRCA website and view document 2235.

For answers to our frequently ask question, please check our PS Series FAQ page.

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PS 9000

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.

Purchase from the CQI website.

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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.

Purchase a printed copy from the CQI website

or

Download an electronic copy.

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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.

Purchase from the CQI website.

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