Industrial Pharmaceutical Microbiology: Standards & Controls - 2015 Edition

Industrial Pharmaceutical Microbiology: standards & controls: 2015 edition

Industrial Pharmaceutical Microbiology: Standards & Controls - 2015 Edition

edited by Geoff Hanlon and Tim Sandle

ISBN 978-0-9573491-1-7 (Hb);    ISBN 978-0-9573491-2-4 (Pb)

The contamination control of pharmaceutical and healthcare environments and processes, together with pre-clinical drug development labs, requires a far more holistic approach than simply choosing technologies and disinfectants. Today the microbiologist is expected to understand industrial processes and cleanrooms, and how to effectively evaluate microbial risks to products from personnel and processes.

Reviews:

"This new second edition is an excellent reference work for those working in industrial pharmaceutical microbiology. It covers all aspects of this complex subject with contributions from many leading figures in the field and is highly recommended."
European Journal of Parenteral and Pharmaceutical Sciences, Vol 19 No 4

"This book is not simply about the science of microbiology for it takes the science into to the industrial setting and offers invaluable advice on how to apply it to the manufacture of pharmaceutical and healthcare products, and for keeping such products within microbial control. A further strength with the book is its topicality, in having the most recent regulations and standards featured. The book features 25 chapters covering environmental monitoring, water systems, vaccines, safety, biological indicators and microbiology laboratory management. Picking the stand-out chapters is difficult, because there are so many good ones. … In summary this book is essential for every pharmaceutical laboratory: scientific, topical and practical"
Pharmig, January 2015

"The 2015 edition of Industrial Pharmaceutical Microbiology is a first-rate reference resource for any professional microbiologist, covering a wide range of topics of relevance to the whole industry. The book starts with the role of the microbiologist and the microbiology laboratory, before moving on to specific microbiological and industry controls. It closes with the issues facing some specialised areas of the industry with their own particular microbiological challenges. … Overall a very useful, well-edited book that will be an invaluable reference to anyone involved in pharmaceutical microbiology."
Clean Air and Technology Review Issue 21, January 2015

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Pharmaceutical Regulatory Inspections

book

Pharmaceutical Regulatory Inspections

Edited by Madhu Raju Saghee
Quality Assurance, Micro Labs, and Director of PHSS, India

Foreword by Peter D. Smith
Vice President, Strategic Compliance, PAREXEL Consulting, USA

ISBN 978-1-899015-89-4 (Hb); ISBN 978-0-9573491-3-1 (Pb)

A unique and comprehensive guide to ensure regulatory compliance and success in pharmaceutical regulatory inspections.

In over 600 pages and twelve chapters this unique book provides a focussed account of regulatory issues from pre-approval inspections and the inspection itself to postinspection and maintaining compliance. This is a book that every pharmaceutical company will wish to study before and during any inspection process to ensure a successful outcome.

Reviews:

"The book is timely, relevant and important… it contains chapters written by a number of international experts and covers everything anyone could possibly wish to know about the inspection process and quality issues affecting pharmaceuticals and healthcare… it also covers the key points that are likely to arise during an inspection or audit. This includes documentation, electronic systems, staff training, hygiene, licencing, compliance and so forth. The quality of the explanations is high and the book is packed full of useful examples and case studies… It is an unique book… an essential item for the book shelf of anyone involved with quality inspections, audits or GMP."
Pharmig News

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Cleanroom Management in Pharmaceuticals and Healthcare

cleanroomtech

Cleanroom Management in Pharmaceuticals and Healthcare

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Edited by Tim Sandle and Madhu Raju Saghee.

ISBN 978-0-9573491-9-3 (Hb) ISBN 978-0-9956666-0-3 (Pb)

Everything you need to know about the operation and management of cleanrooms.

In 26 Chapters and over 600 pages this book provides a unique tool to help you achieve regulatory compliance. It first creates a foundation in history and established practice and then helps you understand how state of the art technology and engineering solutions can deliver the best practice and so provide reliable systems performance.

Since the first edition of this book in 2013 there have been many changes to the approach and methods for cleaning and certifying cleanrooms, most notably the revisions to Parts 1 and 2 of the ISO 14644 series of global cleanroom standards. In addition to setting out the principal changes in these revised standards, many of the other chapters in the book have been updated to reflect their requirements, bringing current practices and Good Manufacturing Practice regulations up-to-date. The book also details the leading international cleanroom requirements and regulations: U.S., FDA, EMA, and ISO. Many of the authors share best practice guidance.

This updated edition will prove an essential resource to all practitioners involved in the operation and management of cleanrooms.

Reviews:

"Highly recommended for the shelf of any cleanroom manager, engineer, microbiologist quality assurance manager - the indispensable guide to cleanrooms and cleanroom management"
Victor Grayson, Sterility Assurance Office, Bio Products

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"The most up-to-date and all-embracing publication covering the complete aspects of cleanroom management within the pharmaceutical and healthcare industries. Contains all the necessary information in the one publication"
Enda McKeon, Elanco, Ireland

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Clinical Research Manual

CRMcover

Clinical Research Manual 

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edited by David Luscombe and Peter D Stonier

The book is available now in both hardback and softback format:

ISBN Hardback 978-0-9956666-1-0
ISBN Softback 978-0-9956666-2-7

In 21 chapters and over 500 pages this comprehensive manual provides detailed information for both beginners and experts. The editors have a wealth of experience between them of the teaching and practice of clinical research, and have selected and reviewed each chapter to ensure completeness and relevance. The chapters are written by acknowledged experts from companies and organisations involved in every aspect of clinical research, each providing practical advice and information.

This new 2017 edition of the Clinical Research Manual includes six new chapters:

  • Dosage Form Design
  • Clinical Trials Organisation
  • Product Registration in the UK and Europe
  • Clinical Trials of Medicines in Children
  • Clinical Trials of Medicines in the Elderly
  • Using Patient-Reported Outcomes as Tools for Clinical Practice

Reviews:

"Each chapter is well written and comprehensive with useful overlap between chapters so that it is easy to see how the areas 'join up' ... a very positive addition to the library."
Pharmaceutical Physician

"A real manual – user-friendly, printed and edited in a style that induces the reader to continual consultation"
Applied Clinical Trials

"All chapters are well written and some of them are really excellent. A lot of useful information can be found both by beginners and experts."
Arzneim-Forsch/ Drug Research

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Compendium of Quality of Life Instruments 1-5 CD-ROM

QoL1-5CD

Compendium of Quality of Life Instruments 1-5 CD-ROM

edited by Professor Sam Salek, Centre for Socioeconomic Research at the University of Wales, Cardiff.

A toolkit of tried and tested Quality of Life instruments.

This Compendium is the first ever comprehensive source of original instruments and related information for researchers and practitioners in the field of health-related quality of life. It contains over 130 questionnaires and translations covering a wide range of disorders.

Volumes 1-5 are now available as a CD-ROM only. The CD-ROM contains the full contents of Volumes 1-5 and allows for clear copies of the data sheets and instruments to be printed.

ISBN 0 471 98145 1

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Compendium of Quality of Life Instruments 6

QoLCD

Compendium of Quality of Life Instruments 6

edited by Professor Sam Salek, Centre for Socioeconomic Research at the University of Wales, Cardiff.

Volume 6 adds to the original Compendium. It updates the instruments as well as adding many new General Quality of Life and Disease-specific instruments and translations.

ISBN 1 899 01553 1

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Compendium of Quality of Life Instruments 8

QoL-7CD

Compendium of Quality of Life Instruments 8

edited by Professor Sam Salek, Centre for Socioeconomic Research at the University of Wales, Cardiff

Volume 8 is the latest addition to the Compendium. It updates and adds many new General, Disease-specific and Specific-groups Quality of Life Assessment Instruments.

ISBN 978-1-899015-79-5

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Pathaid

Pathaid

Pathaid 2017 Edition

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This comprehensive guide to the interpretation of pathology tests and the pathological diagnosis of disease is an invaluable resource for doctors working in general practice.

Updated for 2017

The book is divided into two sections. The first section of the book deals with diagnosis. It lists diseases in alphabetical order and explains the pathology tests and clinical signs that will confirm diagnosis and the differential diagnoses of diseases.

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