The PQG series of Monographs
To purchase Monographs
We have a limited number of sets of Monographs for sale. This consists of ten of the Monographs listed on this page for a special price of £150 inclusive of post and packaging to UK destinations. For destinations outside of the UK, the price is £160.
Single or multiple copies can be purchased and the full price list may be downloaded here.
To purchase a copy / copies, please e-mail the PQG webmaster with your name and address for postage. He will then set up a payment entry on our website Credit/Debit card payments page and send you the instructions for paying. Dispatch will be within 48 hours of payment receipt.
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
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Location, construction and environmental requirements of pharmaceutical factories. Provides practical advice on design and maintenance of premises.The first edition was published in 1987It was revised in 1997 |
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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 1988It was reprinted in 1991 |
03 – Elements and Philosophy of Pharmaceutical Quality Assurance
05 – Pharmaceutical Auditing
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This monograph has been completely re-written by an expert team of auditors from several of the leading UK pharmaceutical companies. Subjects covered include: Audit types and scope Audit techniques and methods The selection and training of auditors and auditees Audit policy and programme management Preparation for audits Conducting audits After an audit There are also a number of appendices giving practical advice on subjects ranging from the desirable attributes for auditors, to techniques for good listening.This monograph will be of considerable help to all those involved with audits whether as an auditor, auditee, or who have managerial responsibility within the pharmaceutical industry.The first edition was published in 1992It was revised in January 2001 |
07 – Contract Manufacture And Analysis
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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 1994It was revised in December 2002 |
08 – Pharmaceutical Documentation
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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
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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 1998It was revised in December 2002It is being revised at the moment and will be available later in 2011 |
10 – Cleaning Validation
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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
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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
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Managing microbiological contamination risks 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 providesa 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 |