Publications

The PQG provides a range of publications for the pharmaceutical industry and its suppliers all of which can be purchased as books and downloadable files (some free of charge) from our shop :

Monographs

The PQG started writing a series of monographs in 1983, with the encouragement of the MHRA, to augment the official Guides to GMP. There are now 11 Monographs available.

Pharmaceutical manufacturing is complex and details of practices vary from manufacturer to manufacturer, whilst remaining within the principles of GMP. PQG monographs are written by our members, who are skilled and experienced professionals within their own fields of interest and activity. They provide a collection of contemporary experience, which is intended to be of assistance to the Pharmaceutical Industry generally. They give a wide practical background and understanding to Good Manufacturing Practice (and other GXPs), Quality Assurance, special topics and may be used for training and development of quality in our industry.

These monographs stress the underlying principles relating to premises, personnel, practices and processes encompassed by an orderly system of working and documentary procedures. They will be of particular interest to management and supervisory personnel engaged in the manufacture and supply of medicines, especially where they are involved in the training and education of staff.

Standards

Although the regulatory authorities publish GMP standards for the manufacture of pharmaceutical products, they do not publish equivalent standards that can be used by suppliers of packaging materials and excipents. PQG has worked with industry experts to produce two internationally recognised standards for suppliers of these materials to the pharmaceutical industry. These standards provide the base of the PQG certification scheme for suppliers to indicate to industry that they meet industry needs and are able to use a numbered PQG Certified Supplier Logo on their stationery.

PQG is also working with other professional groups in the field of new standards for Excipients to fill a gap in regulatory requirements for standards that will aslo reduce the work load on industry and suppliers at the same time.

Guidelines

PQG provides some published guidelines, which provide guidance on how to apply and otherwise use PQG and other GMP standards.

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.

If you are NOT a PQG Member, we would like to notify you by e-mail of new and revised documents and any meetings that PQG are running on these subjects. To do that we need your permission and therefore PQG request that you click the link below, fill in your name and e-mail address on the form and press the blue button.

Click here so that we can notify you of new and revised documents

You can then proceed to download the document that you are interested in and you do not have to repeat the process for subsequent downloads.

PQG will not send any other mail to you other than that associated with our standards and meetings and you can un-subscribe at any time that you receive an e-mail from us.