The PQG series of Monographs

To purchase Monographs

You can now purchase Monographs as books and downloadable files from our shop.  use the tab on the left hand side, or Click here.

Monograph content

Click on the titles for a brief overview of the monograph’s content:

Pharmaceutical Premises and Environment
Pharmaceutical Manufacturing
Elements and Philosophy of Pharmaceutical Quality Assurance
Pharmaceutical Distribution
Pharmaceutical Auditing
Contract Manufacture And Analysis
Pharmaceutical Documentation
Pharmaceutical Packaging Validation
Cleaning Validation
Good Control Laboratory Practice
Microbiological Control for Non-sterile Pharmaceuticals

01 – Pharmaceutical Premises and Environment

Location, construction and environmental requirements of pharmaceutical factories. Provides practical advice on design and maintenance of premises.The first edition was published in 1987.  It was revised in 1997,

We would like to initiate a revision of this monograph.  If you would be interested in being part of a team to work on this, then please contact us using the monographs@pqg.org email address.

02 – Pharmaceutical Manufacturing (Processing and Packaging)

Aspects of “manufacture” of formulated medicines from process design, scale up, process control and packaging to product release. Additional guidance is given including cross contamination, process validation and change control.The first edition was published in 1988.  It was reprinted in 1991.

We would like to initiate a revision of this monograph.  If you would be interested in being part of a team to work on this, then please contact us using the monographs@pqg.org email address.

03 – Elements and Philosophy of Pharmaceutical Quality Assurance

Deals with the concept, current practice and future development of Quality Assurance in pharmaceutical manufacture and development. This is an ideal introduction to the subject and will be of value to all employees within the industry, irrespective of their individual discipline.  The first edition was published in 1994.  It was revised in December 2001

This monograph has been withdrawn from sale because it is in need of an update.  If you would be interested in being part of a team to work on this update, then please email monographs@pqg.org

04 – Pharmaceutical Distribution

This monograph is applicable to all sectors of the distribution network worldwide. The scope is deliberately limited to finished medicinal products for human use, but similar principles will apply to medicinal products for veterinary use.  The first edition was published in 1997.

Following the publication of the revised EU Good Distribution Practice guideline in 2013, this monograph has been withdrawn from sale but we are actively working on updated guidance in conjunction with the European Compliance Academy (ECA).  Chapters of the new guidance are currently being made available for download free of charge via the Guidelines tab in our Shop as they become available.  Use this link to the shop to see those currently available.

 

05 – Pharmaceutical Auditing

This monograph is a practical guide for both auditors and auditees relevant to internal (self inspection) audits, third party audits and regulatory inspections. The first edition was published in 1992 with a completely rewritten second edition published in 2001.

Paper copies of this monograph are currently out of print, but an electronic version is still available for download from the PQG Shop and it is hoped to have a revised edition available early 2015.

07 – Contract Manufacture and Analysis

This monograph expands on the basic requirements in Chapter 7 of the EEC guide to GMP. It has now been revised and expanded to include a significant new section on Contract Analysis and should form an invaluable guide to anyone wishing to establish either contract manufacturing or analytical services.  The first edition was published in 1994.  It was revised in December 2002.

08 – Pharmaceutical Documentation

Provides guidance on the documentation requirements for the successful manufacture and control of medicinal products. It complements the EC GMP Guide and provides a comprehensive, logical and structured reference work for those personnel preparing documents, using documents and training staff in the use of documents.  It was revised in 1995.

09 – Pharmaceutical Packaging Validation

This has been developed from a distillation of the approaches to packaging equipment validation from a number of UK based pharmaceutical companies and offers a practical approach to this complex subject.  The first edition was published in 1998.  The second edition was published in December 2002 and a new edition was produced in January 2013 with a general revision of all areas of the monograph.  This edition is now available as an A5 spiral bound hard copy book, which is printed on demand for us and it is available in our shop.

10 – Cleaning Validation

This has been written by a team drawn from several of the leading UK pharmaceutical companies. It gives practical advice on a subject that is being actively discussed throughout the industry.  This monograph is intended for all those involved in validating the cleaning of pharmaceutical equipment, whether they are employed in development, production or packaging.  The first edition was published in 1999.

11 – Good Control Laboratory Practice

A concise guide to current thinking on Good Quality Control Laboratory Practice offering a valuable source of information as well as an aid to audit.  The First edition was published in March 2005

12 – Microbiological Control for Non-sterile Pharmaceuticals

With a clear expectation from regulatory bodies that microbiological contamination risks associated with non-sterile as well as sterile products should be fully understood and managed, this monograph provides a comprehensive guide on all aspects of microbiological control from facility design to staff training, and from risk assessment to microbiological monitoring.  This Monograph was produced jointly by PQG and Pharmig.  It was First Published in March 2009