PS 9000 Standard
The current version of PS 9000 has been very successful since its launch in 2011 both as an interactive document together with its availability in Print on Demand.
So what next?
The David Abraham and PQG is currently developing a strategy to develop the next generation of PS 9000, which is targeted to align the GMP standard to the new ISO 9001 standard, which is due publication in 2015. As part of this we welcome contribution from all interested parties within the supply chain and industry.
Please mail Partners@pqg.org for further information
Excipient GMP standard & certification scheme (Excipact consortium)
Excipact certification scheme has been developed and has been launched. Details can be viewed at the following web site http://www.excipact.org/
Excipact event held by PQG at RPSGB on May 16th 2012 (for details and presentations click here)
ISO 15378 revision
The 15378 has been though a number of revisions since its original publication. Tony Harper and the PQG continue to provide contribution to current developments in the standard’s development.
Continue to return to this area for future updates
Excipients risk assessment (with IPEC)
Collaboration with IPEC in the Excipients arena continues with Ian McKeown providing valued support to the working parties.
Guidelines for Artwork Origination
Origination guidance has long been a hot topic over the years and whilst PS 9000:2011 has established the requirements it has been recognised that a separate document will provide a higher level of knowledge and understanding to the Pharmaceutical industry, as well as targeting to establish the foundations of best practice in this area.
With this in mind the PQG is supporting a project to establish guidelines in this subject matter and would welcome contribution from interested organisations and individuals who would like to be involved in the future publication.
If you are interested please mail Partners@pqg.org for further information.