The PQG series of standards: PS 9000, PS 9100 and PS 9004
PS 9000:2011 is an application standard developed by the PQG for the manufacture of packaging materials for medicinal products and now for orally inhaled medicines. The document defines specific requirements and guidance for GMP integrated with the requirements of ISO 9001, ISO 15378 and IPAC RS.
PS 9000:2011 was updated and revised in September 2011 to include additional requirements particularly for electronic origination of artwork, the requirements of ISO 9001, ISO 15378 and also for packaging materials for Orally Inhaled and Nasal Drug Products.
The revised standard, which also includes guidance for the application of the standard, is available as a book in A5 spiral bound format from our shop in the Standards section. It can also be downloaded free of charge in active PDF format.
For more details of the update process see the PS Series update in Partners Group tab.
PS 9004 Pharmaceutical Packaging Materials – A Guide to PS 9000:2001 (which has been replaced by PS 9000:2011).
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.
Although the standard, which this guide is based on has been superseded, PS 9004 does contain a lot of interesting case studies and explanations which remain valid and are therefore useful background material.
PS 9004 is available from our shop in the Guidelines section. where it can be downloaded free of charge.
PS 9100 as a standard and guide is now superseded by the IPEC/PQG GMP guide for pharmaceutical excipients which is available from our shop in the Guidelines section where it can be downloaded free of charge and the EXCiPACT TM Excipients GMP standard. Additionally the type of risk assessment first developed in PS 9100 is now a requirement of the Falsified Medicines Directive, and a suitable model is now being proposed by a team including PQG, IPEC Europe and others.