Many of the standards and other documents developed and produced by PQG are going to be made available free of charge to download for personal use only.
New documents will be added to those below and all documents will be updated occasionally.
If you are a PQG Member you will automatically be notified of the new and changed documents and need to do no more than be signed into the website and download the document(s) that you are interested in.
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Documents for download
This Standard specifies GMP requirements and guidance within a quality management system (QMS) for suppliers of packaging materials and origination/artwork to the pharmaceutical industry and has been developed through collaboration between the pharmaceutical industry and its suppliers. The Standard provides an important reference text to assist medicinal product manufacturers and their suppliers in their understanding of their respective responsibilities in producing materials of the requisite quality, in order that the final product is fit for purpose.
The document has been designed to be compatible with Adobe reader 7, however to enhance user experience Adobe reader 9 and above are recommended.
This document is large (22MB) and may take a long time to download if you have a slow speed connection.
This document is now available as a book in A5 spiral bound format from our sales page.
PS 9000:2011 Training Package
This training package has been 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.
More details are available on the PS series update page, but if you are new to PS 9000 you will need to become familiar with the contents of the entire Standard and its requirements.
Risk Management Guide
The objective of the guide is to help organisations and their suppliers adopt a common approach to risk management to reduce supply chain risk through application of the principles and tools of risk management. The guide emphasizes the importance for pharmaceutical and medical device industries to understand customer needs and identify potential hazards that may exist within the supply chain, by applying risk management when making sourcing decisions. This will help suppliers understand regulatory requirements and the expectations of the industries concerned.
EXCiPACTTM Excipent GMP standard
The Excipact standard builds on the existing ISO 9001 Quality Management System Standard to add a standard that covers the additional requirements necessary for GMP and GDP Certification. The aim has been to develop a global voluntary standard against which pharmaceutical excipient manufacturers, suppliers and distributors can be certified by appropriately qualified 3rd party certification organisations to obtain GMP and GDP certificates. This process will also generate expert audit reports for the benefit of auditees and their customers internationally.
IPEC-PQG Excipients GMPs Guide
The IPEC-PQG Excipients GMPs Guide proposes GMP appropriate for the manufacture of excipients and is a joint initiative between the International Pharmaceutical Excipients Council (IPEC), as IPEC-Americas and IPEC Europe and the Pharmaceutical Quality Group (PQG). It incorporates the IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients, 2001 with the PQG’s PS 9100:2002 Pharmaceutical Excipients.
The Guide makes an essential contribution to the wider understanding and attainment of good manufacturing practice appropriate for the excipient supply industry. Excipient manufacturers and their customers can be assured that excipients manufactured according to this Guide will meet internationally accepted good manufacturing practice principles.
This 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 and although PS 9004 is a guide to PS 9000:2001, which has been replaced by PS 9000:2011, it contains examples, which may still be of use in training staff.