The PQG series of monographs
The PQG, together with many expert professionals in the industry and volunteers with many years experience, are proud to publish a series of globally acclaimed monographs. Please click on the links below to find out more about these essential publications.
Monographs on Pharmaceutical Quality Assurance
With the encouragement of the UK Department of Health, the Pharmaceutical Quality Group initiated a project in 1983 with the intention of writing a series of monographs to augment the official Codes of Good Manufacturing Practice. Such codes stress the underlying principles relating to premises, personnel, practices and processes encompassed by an orderly system of working and documentary procedures.
Pharmaceutical manufacturing is complex and details of practices vary from manufacturer to manufacturer whilst remaining within the principles of Good Manufacturing Practice. The monographs are written by members who are skilled and experienced 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 by giving a wide practical background to Good Manufacturing Practice and Quality Assurance.
These monographs 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.
For more information on Monographs contact .Click on the titles for a brief overview of the monograph's content:
Pharmaceutical Auditing revised June 2001
Cleaning Validation - new in June 1999
Pharmaceutical Packaging Validation - reprinted with minor revisions - March 2002
Pharmaceutical Premises and Environment - revised May 1998
Pharmaceutical Manufacturing (Processing and Packaging)
Elements and Philosophy of Pharmaceutical Quality Assurance - New Revised Edition, December 2001
Pharmaceutical Distribution - New Revised Edition, 1997
Contract Manufacture And Analysis
Pharmaceutical Documentation
Good Control Laboratory Practice
Microbiological Control for Non-sterile Pharmaceuticals (new March 2009)
Good Control Laboratory Practice
A concise guide to current thinking on Good Quality Control Laboaratory Practice offering a valuable source of information as well as an aid to audit.
Pharmaceutical Auditing
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.
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.
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. Due to its popularity this Monograph has been reprinted with minor corrections in March 2002.
Pharmaceutical Premises and Environment
Location, construction and environmental requirements of pharmaceutical factories. Provides practical advice on design and maintenance of premises.
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.
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.
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.
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.
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.
Microbiological Control for Non-sterile Pharmaceuticals (Joint with Pharmig)
Managing microbiological contamination risks
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