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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Pharmaceutical Regulatory Inspections

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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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IPM12: Best practices in microbiology laboratory training

IPM12: The use of culture media in pharmaceutical microbiology

by Tim Sandle

Supplement 12 from Industrial Pharmaceutical Microbiology Standards & Control. A new updated version of the book is published annually in line with changes in regulations and current practice.

This is supplied in booklet format. The supplement is also available as a downloadable pdf (see pdf Supplements).

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CRM29: Pharmaceutical and medical device combination products

CRM29: Pharmaceutical and medical device combination products

Supplement 29 from Clinical Research Manual

Pharmaceutical and medical device combination products

by David Jefferys
 
This booklet explores the regulatory control of combination products and highlights key areas.

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Clinical Research Manual

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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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