Monographs

The PQG has been developing & revising a series of monographs since 1983. They augment the official Rules & Guidance to GMP and are recognised by the MHRA as: ‘important reference texts to assist medicinal product manufacturers and their suppliers in their understanding of their respective responsibilities in producing materials of the requisite quality.’

Gerald W Heddell : 2011

Director, Inspection Enforcement & Standards Division Medicines and Healthcare products Regulatory Agency

Eleven Monographs available in one form or another.

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) and Quality Assurance 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 within a comprehensive Pharmaceutical quality System. 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.

Further details are obtainable by clicking on the image for each article.

All Monographs except 3 and 4 are available as e-documents for reference. The content of Monographs 3 & 4 do not come up to current regulatory requirements and they are being revised prior to re-publication.