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 newest 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.

Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies

Tim Sandle

Reference

PDA/DHI

Have you ever asked yourself, "Where in the Good Manufacturing Practices (GMPs) does it say I have to do follow certain methods?" 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.

GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Fifth Edition Revised & Expanded

James L. Vesper

Audit and Control for Healthcare Manufacturers: A Systems-Based Approach

Jennifer Sandle

The complete guide to pharmaceutical microbiology and sterility assurance. This book has been written by the leading experts in the field. This book is an indispensable reference guide for the pharmaceutical sector and to students of microbiology. This book therefore represents an unparalleled and unprecedented text in the field of pharmaceutical and medical device microbiology. Perhaps even more outstanding is the fact that this book not only covers subject matter and technical content which is established as best and expected practice, but also includes content regarded as possible, future and emerging technology or processes. 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 requirements for contamination control will become even more stringent than today. Isolators or blow-fill-seal equipment have already replaced the conventional clean rooms and UDAF-hoods in many production facilitities. Conventional microbiological monitoring methods, requiring 3 to 5 days of incubation will become inappropriate. Equipment is already available allowing real time, simultaneous viable and non-viable counting. This book covers these key trends and developments. 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. Foreword by Hans van Doorne, Chair of EDQM, Committee on Microbiology. Contents 1. The Essentials of Pharmaceutical Microbiology by Tim Sandle and Madhu Raju Saghee 2. Relevance of Microorganisms in Pharmaceutical Processing by Ossama M. El-Tayeb 3. Microbial Contamination and Spoilage by David G. Allison 4. Microbiological Considerations in Medical Device Industry by Martell Winters 5. Selection of Microbiological Culture Media and Testing Regimes by Tim Sandle 6. Microbial Identification by Ziva Abraham 7. Microbial Examination of Non-sterile Products by Jaymie Tomes and Florence Wu 8. Practical Approaches to Sterility Testing by Tim Sandle 9. Microbial Aspects in Cleaning Validation by Andrew Walsh 10. Validation of Microbiological Methods by Sandy Rubio 11. Selection and Validation of Disinfectants by Paul Vina, Sandy Rubio and Tim Sandle 12. Auditing a QC Microbiology Laboratory by Andy Martin 13. Quality Assurance in a Microbiology Laboratory by Christophe Barcella 14. Environmental Monitoring by Tim Sandle 15. Microbial Content Testing of Pharmaceutical and Biotechnologically Derived Products by Dilip Ashtekar and Tim Sandle 16. Bacterial Endotoxins Test by Masakazu Tsuchiya 17. Antimicrobial Effectiveness Testing by Scott V. W. Sutton 18. Monitoring of Microbiological Quality Attributes of Water for Pharmaceutical Use by Dilip Ashtekar 19. Investigation of Microbiological Data Deviations by Monica Lagomarsino 20. Alternative Microbiological Methods and New Pharmaceutical Microbiology Curriculum by Claudio D. Denoya 21. The Implementation of Rapid Microbiological Methods by Michael J. Miller Total 33 chapters included in the book. Complete information at businesshorizonsdotcom

Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices

Science & Math

Madhu Raju Saghee

Edward C. Tidswell

Biological Sciences

Business Horizons

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Books by Tim Sandle