Publications Books

Industrial Pharmacy Books

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

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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Clinical Research Manual

CRMcover

Clinical Research Manual - New 2013 edition

edited by David Luscombe and Peter D Stonier

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.

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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Cleanroom Management in Pharmaceuticals and Healthcare

cleanroomtech

Cleanroom Management in Pharmaceuticals and Healthcare

Edited by Tim Sandle and Madhu Raju Saghee.

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.

An essential read for practitioners in cleanroom technology.

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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GMP Manual: Online single user version



GMP Manual: Online single user version

All you need to know about GMP!

Available online TRY IT FREE ONLINE NOW click here

The Single user licence allows

  • Access with username and password
  • Access for one single personalised user

The price includes the initial download and the first year's updates. Thereafter licensees will only have to pay an update fee of approximately £255.

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GMP Manual Update 11

Update 11 GMP Manual

This latest update to the GMP Manual consists of 620 pages. 

As many regulatory requirements have been updated and some new documents published since the beginning of the year, this Update includes many new and updated chapters from the "GMP Regulation" part of the Manual.

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CRM29: Pharmaceutical and medical device combination products

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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GMP Manual: Online Corporate version

GMP Manual: Online Corporate version

All you need to know about GMP!

Available online - TRY IT FREE ONLINE NOW click here

The Corporate licence allows

  • Access by identification of fixed IP addresses
  • Access for all employees of a company

The price includes the initial download and the first year's updates. Thereafter licensees will only have to pay an update fee of approximately £750.

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GMP Manual: CD-ROM only

GMP Manual: CD-ROM only

GMP Manual: CD-ROM only

All you need to know about GMP!

UPDATES NOW AVAILABLE

For pharmaceutical manufacturers, suppliers, consultants, engineering companies and related industries.
This compendium for the pharmaceutical industry and their suppliers is the most extensive GMP knowledge database worldwide.
The complex GMP spectrum is explained in detail in more than 3,500 pages. This compendium is updated twice a year, thus keeping you up to date at all times.

Available in three formats - Loose-leaf book plus CD-ROM; CD-ROM only; Online

ISBN 978-3-934971-55-4

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GMP Manual as Loose-leaf book and CD-ROM

GMP Manual as Loose-leaf book and CD-ROM

GMP Manual as Loose-leaf book and CD-ROM

All you need to know about GMP!

UPDATES NOW AVAILABLE

For pharmaceutical manufacturers, suppliers, consultants, engineering companies and related industries.
This compendium for the pharmaceutical industry and their suppliers is the most extensive GMP knowledge database worldwide.
The complex GMP spectrum is explained in detail in more than 3,500 pages. This compendium is updated twice a year, thus keeping you up to date at all times.

Available in three formats - Loose-leaf book plus CD-ROM; CD-ROM only; Online

ISBN 978-3-934971-55-4

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Industrial Pharmaceutical Microbiology: standards & controls

Industrial Pharmaceutical Microbiology: standards & controls

Industrial Pharmaceutical Microbiology: standards & controls

edited by Norman Hodges and Geoff Hanlon

In over 500 pages and 21 chapters, this book covers the entire spectrum of industrial pharmaceutical microbiology from regulatory requirements to disinfectants, sterility testing, environmental monitoring and hazard analysis.

A new updated version of the book is published annually in line with changes in regulations and current practice.

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IPM12: Best practices in microbiology laboratory training

IPM12: The use of culture media in pharmaceutical microbiology

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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Revised Annexes 15, 16, 17, 19 and Part 2 of Eudralex Volume 4

Revised Annexes 15, 16, 17, 19 and Part 2 of Eudralex Volume 4 to the EU Guide to Good Manufacturing Practice

Revised Annexes 15, 16, 17, 19 and Part 2 of Eudralex Volume 4 to the EU Guide to Good Manufacturing Practice

Now available in one pocket-sized booklet

  • Annex 15 - Qualification and Validation
  • Annex 16 - Certification by a Qualified Person and Batch Release
  • Annex 17 - Parametric Release
  • Part 2 (Formerly Annex 18) - Basic Requirements for Active Substances used as Starting Materials
  • Annex 19 - Reference and Retention Samples

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Quality Assurance of Aseptic Preparation Services 4th edition

Quality Assurance of Aseptic Preparation Services 4th edition

Quality Assurance of Aseptic Preparation Services 4th edition

edited by Alison Beaney

It is widely recognised that preparation of intravenous injections should be carried out in pharmacy departments rather than on wards, using defined standards. This edition provides information and national guidance on unlicensed aseptic preparation.

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Pathaid

Pathaid

Pathaid 2014 Edition

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 2014

The book is divided into two sections. The first section lists the pathology tests available and gives guidance on how to interpret them. This includes a guide to the collection and storage of specimens for pathology tests.

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Manufacture of Sterile Products

Manufacture of Sterile Products

Manufacture of Sterile Products

Now available in one pocket-sized booklet

  • MHRA: Annex 1 to EU Guide Manufacture of Sterile Medicinal Products (revised February 2008)
  • PIC/S: Validation of Aseptic Processes
  • FDA: Sterile Drugs Produced by Aseptic Processing

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International Handbook of Prostate Cancer

International Handbook of Prostate Cancer

International Handbook of Prostate Cancer

3rd edition edited by Professor David Kirk

In this book written for the working clinician, an international group of distinguished authorities have addressed the issues raised by prostate cancer. All the authors are enthusiasts as well as experts. It is hoped that this enthusiasm has come through in their contributions and will be shared by the readers who manage this challenging disease.

 This book is available for sponsorship.

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International Handbook of Colorectal Cancer

International Handbook of Colorectal Cancer

International Handbook of Colorectal Cancer

edited by Professor Jim Cassidy

Colorectal cancer is a common and growing disease in all developed nations of the world. This book has been written by a series of international experts dealing with selective areas of colorectal cancer. In each chapter the authors have produced a "state of the art" contribution, the aim being to enable the reader to quickly assimilate the latest thoughts and findings on each topic.

 This book is available for sponsorship.

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International Handbook of Breast Cancer

International Handbook of Breast Cancer

International Handbook of Breast Cancer

edited by Dr Stephen Johnston

This handbook has been developed as a modern guide and reference for working clinicians and trainees involved in treating women with breast cancer. This book provides guidance on the complex issues involved in the diagnosis and treatment of breast cancer.

 This book is available for sponsorship.

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International Handbook of Chlamydia

International Handbook of Chlamydia

International Handbook of Chlamydia

4th Edition edited by Dr Timothy R Moss

Chlamydia trachomatis is a bacterial sexually transmitted disease of global public health significance - it is estimated that 89 million new cases occur each year. It is associated with trachoma, lymphogranuloma venereum and genital infection. Chlamydial infection can cause pelvic inflammatory disease, resulting in ectopic pregnancy and infertility, neonatal infections, epididymitis and joint inflammation in men. Some forms of chlamydia cause chest infections and acute pulmonary infections, sometimes with chronic, crippling and killing complications.

 This book is available for sponsorship.

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