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.The monographs:
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.
Pharmaceutical Distribution
This mongraph 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.
Pharmaceutical Auditing
Auditing is an essential feature of pharmaceutical manufacture and control, for both regulatory and management purposes. Principal chapters cover audit types and scope, internal and external audits and audit management.
Bulk Pharmaceutical Chemicals
Details practical GMP guidelines for Bulk Pharmaceutical Chemicals. Principal chapters cover: premises and equipment; materials management; quality assurance and quality control; rejection, recovery, reprocessing and returns; documentation and systems.
Pharmaceutical Contract Manufacture
Expands on the basic requirements included in Chapter 7 of the EC Guide to GMP.
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.
All of the above mongraphs are available from:
EITHER
The Institute of Quality Assurance
PO Box 712,
61 Southwark Street,
London SE1 1SB
England
Tel: +44 (0)171 401 7227
Fax: +44 (0)171 401 2725
OR
David Begg Associates,
10 High Market Place,
Kirkbymoorside,
York YO6 6AX
England
Tel: +44 (0)1751 432999
Fax: +44 (0)1751 432450
Price:
UK deliveries £10 per monograph including postage
Overseas deliveries £11 per monograph including air mail postage
Sterling cheques payable on a UK bank to David Begg Associates MUST BE RECEIVED WITH ORDER.