PS Series Update

PS 9000

The revision of PS 9000:2001 Pharmaceutical packaging materials to PS 9000:2011 has been completed by a Pharmaceutical Quality Group working party led by David Abraham. The new Standard was launched at the RPSGB, London on 14th September 2011.

The structure of PS 9000:2011 is based on ISO 15378, and this version has been developed with input from pharmaceutical clients and suppliers.   IPAC-RS  have helped significantly with the introduction of requirements and guidance for Orally Inhaled and Nasal Drug Products (OINDP), and detailed requirements now also include electronic origination of artwork.

The Standard is now available from our downloads page as a freely downloadable interactive electronic PDF and guide which is printable and can therefore accompany individuals as they assess themselves, or their suppliers, through reviews and audits.  The potential for printed copies to purchase is also being investigated.

Training Package

The training package was developed to assist 3rd party Certification Bodies (CBs), other auditors and companies in the transition from PS 9000:2001 to PS 9000:2011. It highlights the changes that have been made to the Standard and is not inclusive of all material in PS 9000:2011. Some material has been included verbatim and other material has been summarized or paraphrased.

It should be noted that every change to the standard has been included in this package thereby providing a roadmap to transitioning to PS 9000:2011.

The training package has been broken into 6 modules to facilitate training sessions. Detailed information from each annex (excluding annex F) is also included. Annex F, which addresses certification is being reviewed and it will be published once completed.

This training package also highlights the documented procedures and risk assessments that are required in the revised Standard, PS 9000:2011. This will give a company a clear understanding of the work required to comply with PS 9000:2011 since all documented procedures and risk assessments are included in the training.

If you are new to PS 9000 you will need to become familiar with the contents of the entire Standard and its requirements.

The training package for PS 9000:2011 vs PS 9000:2001 is available on our downloads page.

Transition period

The transition period for supplier certifications to PS 9000:2001 to PS 9000:2011 is from 14th September 2011 to 30th September 2013.

PS 9100

PS 9100:2002 Pharmaceutical excipients is both a standard and a guide. 

The guide has been superseded by the IPEC-PQG GMP Guide for Pharmaceutical Excipients

The PS 9100:2002 standard currently remains valid but will be superseded early in 2012 by the EXCiPACTTM Certification Standards for Pharmaceutical Excipients: Good Manufacturing Practices & Good Distribution Practices.  See the Partners Group/Excipact page for more details.