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A selection of books by Tim Sandle
Biocontamination Control for Pharmaceuticals and Healthcare - 2nd edition
GMP Validation: A guide to international regulatory requirements
GMP Validation provides a text for those who need to assess validation and ensure that validation is conducted according to current GMP. These include the validation manager and personnel engaged in validation activities; quality assurance; quality control; R&D; and production personnel. Some of the scientific aspects will also appeal to students, especially those working within or aspiring to enter the pharmaceutical sector. The book also serves as a good starting point for those who are tasked with auditing validation systems or items of equipment or processes.
This comprehensive handbook is comprised of 30 chapters which are divided into two parts. The first part is dedicated to the management process, with an emphasis upon appropriate formality and risk-based approaches. The second part focuses on case studies, providing an overview of different GMPs and standards for different areas of validation and qualification. The book concludes with four useful appendices providing templates to aid the reader.
Available via Euromed.
Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality.
The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control.
Available via Amazon or from Elservier.
Elstree is synonymous with the movie industry, but it also has
another tale to tell – over 120 years as a life science innovator. A
former farm, land across the reservoir built by French prisoners during
the Napoleonic wars, became a series of laboratories under the Lister
Institute of Preventative Medicine. The work was varied, but pathogen
safety and nutrition came to dominate the researchers before the
greatest success was achieved through a pivotal role in the global
eradication of smallpox. From Lister sprung the Blood Products
Laboratory, a global innovator in plasma products (including
immunoglobulins and the world’s first factor VIII for the treatment of
haemophilia).
The Lister Institute is no longer active in producing medicines and BPL has a new life as part of Kedrion BioPharma. Yet the legacy remains, and the three central elements are captured by this book’s title – Blood, Plague, and Smallpox.
The history of the site is an exciting story in itself – criminals sought out by Scotland Yard; dedicated workers contracting the very pathogens they are experimenting on; periodic political and biological threats to the site remaining open (from Margaret Thatcher to mad cow disease), this is not a dry history but one of twists, turns, survival and scientific excellence.
Industrial Pharmaceutical Microbiology: Standards and Controls 6th Edition
Industrial Pharmaceutical Microbiology: Standards and Control covers the entire spectrum of industrial pharmaceutical microbiology, as applicable to pharmaceuticals and healthcare. Connect instantly with regulations and current best practices on everything from disinfectants to sterility testing; environmental monitoring to hazard analysis; and from pharmaceutical processes to biological indicators. All of this is developed from an international perspective, where different regulations are compared and contrasted together with insightful commentary as to best practices.
Industrial Pharmaceutical Microbiology: Standards and Controls provides clear, practical and up-to-date guidance for handling virtually every compliance and operational challenge associated with pharmaceutical microbiology.
Recalls of Pharmaceutical Products: Eliminating Contamination and Adulteration Causes
Audit and Control for Healthcare Manufacturers: A Systems-Based Approach
From Roman remains to the engineering ingenuity of Brunel (both father and son) to unkept gardens and urban graffiti, this book captures 111 inspiring images, showcasing the depth of detail that is possible with black and white photography.
The images are accompanied by text discussing the historical or societal context, as well as an appreciation of the photographic image.
A major theme is antimicrobial agents (and the role played by pharmaceutical microbiologists in developing and delivering these agents) and the growth in microbial resistance. In the last two decades, the rate at which bacteria are becoming resistant to current antibiotic treatments has substantially increased. This trend is threatening the ability of medical staff to carry out routine operations or transplants in the future. This has been compounded not only by microorganisms that are resistant to one antimicrobial or another, but due to the rise of multi-drug resistant microorganisms (the so-termed ‘super bugs’).
Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies
Avoidance of hazards and assessment of risk have long been part of the manufacture of pharmaceuticals and healthcare products. A high quality drug product must be free from contamination and reliably deliver the intended therapeutic dose as stated on the label and to achieve this manufactures must always be mindful of risk.
Tim Sandle's book incorporates regulatory perspectives, scientific methods and practical examples to describe approaches to problem solving when assessing, managing and reviewing risk. The book is divided into four sections that present a formal approach to risk. The first section provides a look at risk assessments and hazards, exploring the origins, looking at key concepts and philosophies and assessing the regulatory perspective. An overview of available tools for risk assessment and problem solving leads into specific 'soft skills' that can help to run an effective meeting, oversee a project and report root cause analysis and risk outcomes. The book concludes with an extensive set of case studies to show real-world applications of the tools and techniques presented. The wide range of topics presented throughout the four sections includes risk considerations for aging pharmaceutical facilities, application of quality risk management to cleanroom design and process incident investigation.
Sandle's Pharmaceutical Microbiology Dictionary
GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Fifth Edition, Revised & Expanded
Have you ever asked yourself, "Where in the Good Manufacturing Practices (GMPs) does it say I have to do _______?" If so, look no further than PDA's GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, fifth edition, Revised and Expanded.
As companies strive to harmonize global requirements for quality systems, the 5th edition of this text provides an overview of the 34 essential global cGMP requirements that are typically included in a modern pharmaceutical quality system, including data integrity and how they have evolved. Explore risk-related questions, delve into several expectations for each quality system element encompasses, and review real-world examples from cGMP regulations from the US FDA, Health Canada, the European Union, the World Health Organization, and the International Conference on Harmonization (ICH).
If you're looking for an enhanced understanding of GMP in practice, this text is a must-have for your reference collection.
See: PDA
Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers
Sterility Testing of Pharmaceutical Products
The central argument of the book is that control of the process and environmental control are considerably more important guarantors of sterility than the questionable comfort gained from a 'pass' result at the end of the incubation of a sterility test.
This book balances theoretical, and sometimes philosophical, discourses about the nature of sterility and the conceptual problems of microbial viability with sound practical guidance on how to validate the sterility test, problematic products as well as solutions on how to control the environment and review manufacturing process parameters, while navigating the regulatory minefield.
The aim of the book is to present the sterility test as a final product release test as seen in the past, the present and with a view towards the future and is aimed at quality assurance personnel, production staff, microbiologists, students and those with an interest in medicinal products.
The reference is:
Sandle, T. (2013). Sterility Testing of Pharmaceutical Products, DHI /PDA: Bethesda, MD, USA (ISBN: 1933722746)
Theory and practice for diseases diagnosis
“Risk Management and Risk Assessment for Pharmaceutical Manufacturing: A contamination control perspective”. The book has been written by Tim Sandle.
The book presents an overview of risk management and risk assessment for those working in the pharmaceutical and healthcare sectors. An understanding of risk management and risk assessment is today becoming a prerequisite for those working in quality control and quality assurance, and for those active in pharmaceuticals and medical devices, Quality Risk Management it is a mandatory requirement. The book expands upon this subject through a series of case studies, utilizing tools like HACCP and FMEA.
The core chapters are:
- Risk management and risk assessment
- Risk tool methods
- Case study: environmental monitoring
- Case study: aseptic processing
- Case study: non-sterile product manufacturing
- Case study: sterility testing isolator
- The book balances regulatory guidance, theoretical concepts and practical examples.
The book is available from Amazon.
For Amazon U.S., go to Amazon US.
For Amazon U.K., go to Amazon UK
Cleanroom Management in Pharmaceuticals and Healthcare
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. View the contents here.
Available from Euromed.
Cleaning and Disinfection Handbook
The Cleaning and Disinfection handbook is aimed at those working within the pharmaceutical and healthcare sectors, as well as providing valuable information for students and for the general reader. The book provides comprehensive detail on different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations; expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards. Assembled by expert practitioners, the book balances theoretical concepts with sound practical advice, and is likely to become the definitive text on keeping contamination in control within clean areas and controlled environments.
The book is available as a paperback or as an e-book.
To order and for more details, see Amazon U.S. (paperback) / Amazon U.S. (e-book)
Amazon U.K. (paperback) / Amazon U.K. (e-book)
Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations
The book is available as a hardback edition.
To order and for more details, see Amazon U.K.
Histology Systems: Short Atlas
Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices
The results of 45 years of scientific and technological development are laid down in these 33 chapters. These chapters, all written by international experts, give a vivid picture of today s pharmaceutical microbiology. The high standard of the chapters makes it an essential reference guide that should be on the shelf of everyone who is involved or interested in this field. Experts from top pharmaceutical companies like Baxter, Johnson and Johnson, Amgen, Pfizer, Patheon, Sartorious, Gador, Catalent, British NHS, GE Healthcare and many more top experts from industry and academics have come together to create this collection of knowledge of Microbiology as related to Pharmaceuticals, Medical Devices and Biotechnology. The list of authors includes chair and members of USP expert committee on Microbiology and Sterility Assurance, president and senior experts in Parenteral Drug Association, ISPE and ASTM.
The book is available as a hardback edition.
To order and for more details, see Amazon U.S.
Guide to Cleanrooms
The book is available as a paperback and as an e-book.
Amazon U.S. (paperback)
Amazon U.S. (e-book)
Amazon U.K. (paperback)
Amazon U.K. (e-book)
Data Review and Analysis for Pharmaceutical Microbiology
See: Amazon U.S. or Amazon U.K.
Sterilization: Practical Approaches
Sterilization: Establishing the Process
Cleaning and Cleanrooms
In the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical and biotech manufacturers stay abreast, streamline processes and comply with regulators.
We have now collected bestsellers and added materials that have not published before in electronic book form covering three vital topics:
- Environmental Monitoring
- Cleaning and Cleanrooms
- Sterilization
Pharmaceutical Microbiology Glossary
A glossary of common terms used in pharmaceutical microbiology, cleanrooms and healthcare. The book contains over 300 definitions. The book is aimed at new and experienced microbiologists, students, quality personnel and general readers.
This book is available as an e-book.
Amazon U.S. (e-book)
Amazon U.K. (e-book)
LABORATORY TECHNIQUES WITH APPLICABILITY IN ROUTINE PRACTICE: DIAGNOSIS OF DISEASES
Pharmaceutical Regulatory Inspections - Guide to Quality and Compliance - 2nd edition
This book contains practical advice and insight to help different types of pharmaceutical organisations prepare for GMP inspections, understand key regulatory issues and review inspectorate trends and findings. The book compares inspections by the major regulatory agencies, the FDA, EU and Japan, as well as international inspections.
This is a unique book in which agency inspectors and seasoned industry experts express their views and provide advice and tips on how to successfully pass regulatory inspections.
In over 500 pages and 14 chapters this book, unlike any other, brings together a diverse range of experts to provide a focussed account of regulatory issues from pre-approval inspections and the inspection itself, to post-inspection and maintaining sustainable compliance. There is even a chapter on virtual regulatory inspections which takes into account the ‘new normal’ of the pandemic age.
If you wish to ensure that your company will successfully pass the increasingly important regulatory inspections process, then this book is an essential item for your bookshelves.
Available via Euromed
Current Perspectives on Environmental Monitoring
Available from Amazon U.K.
Best Practices for the bacterial Endotoxin Test: A Guide to the LAL Assay
Edited by Tim Sandle, the Pharmig guide to the Bacterial Endotoxin Test (BET) has been written by industry experts, including Anna Upton, and it provides the reader with an overview of the history, regulation and practical use of the different BET assays. Information on the method development, validation and routine testing are discussed as well as more advanced subjects such as depyrogenation, medical devices, trouble shooting and problem samples. This guide should provide a useful reference document for LAL users and laboratory management.
The guide is available from Pharmig.
LAL Fact Sheets
- What is LAL/BET?
- Calculation of Endotoxon Limits
- Medical Devices
- Gel Clot Methods
- Photometric Methods
- Product Validations Quantitative Methods The fact sheets are only available from Pharmig.
Guide to Microbiology Laboratories in the Pharmaceutical Industry
The guide is only available from Pharmig.
Electronic Training Pack 1: Setting up & managing an effective training programme in the Micro Lab and Electronic Training Pack 2: Best practices in Microbiological Documentation
The second, presents an overview of the most efficient, as described by quality and microbiology personnel, practices in maintenance of the QC aspect of the microbiology laboratory and its associated documentation with reference to current regulatory expectations.
Example documents are also included to assist companies in improving their documentation practices. The pack is available from Pharmig.
E-guide to cleanrooms
The E-Guide to Cleanrooms (an Amazon e-book)
Written by Tim Sandle, this e-book provides an overview of how cleanrooms work, how they should be certified, and what is required for on-going compliance in relation to contamination control.
Risk Management Library Volume 4: Practical Approaches to Risk Assessment and Management Problem Solving: Tips and Case Studies
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