PS 9004: a guide to the GMP requirements of PS 9000:2001 pharmaceutical packaging materials
PS 9004, developed by the CQI's Pharmaceutical Quality Group, is a comprehensive guide into the reasons for the specific pharmaceutical GMPs stated in PS 9000 and the rationale for some of the clauses in technical agreements for the supply of packaging material. It includes a range of authoritative reference sources and case studies, which illustrate real-life problem scenarios. With its rich source of material and guidance to trainers, it will be a valuable aid for the education and training of appropriate personnel within the packaging materials supply chain and pharmaceutical industries.
PS 9004 has been developed because suppliers to the pharmaceutical industry do not always appreciate fully the reasons why the GMP requirements defined in PS 9000 are needed. The guide provides in clear language the appropriate reason for each critical requirement and sources of further useful reference information. It 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. The document has been developed by a team of pharmaceutical and supply industry personnel led by Roy Evans.
To support quality improvement activities in the pharmaceutical sector, it has been decided to make this guidance document freely available as a download. The more easily used printed copies are also available at a nominal charge - see the order form (pdf format)
We encourage those downloading the document to provide contact details so that we can keep them up to date with developments in the area. Details provided will only be used to provide information on activities relevant to the pharmaceutical sector and not for more general updates and, in accordance with our data protection policy, will not be passed to a third party.
Download the document (2.1 Mb pdf document)
