Pharmaceutical Regulatory Inspections: Every Inspection a Success Story - a Practical Guide to Make it Happen

Madhu Raju Saghee

Euromed Communications

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

Tim Sandle

Edward C. Tidswell

Biological Sciences

Business Horizons

In todays contemporary pharmaceutical industry, the focus has slowly but surely shifted from the elusive research pipeline and latest blockbuster molecules to current processes, efficiencies and manufacturing systems. A path most often taken by manufacturers today in this direction includes improving their overall quality and compliance efforts. This results in a two-pronged approach of minimizing the litigation cost and concurrently improving the overall quality of the products and efficiencies in their processes and procedures. This book provides current thinking and approaches to achieving quality and compliance from top industry experts and is pioneering in bringing this wealth of information together in a single volume which will be of great use to the pharmaceutical industry. Compliance and quality issues have been comprehensively covered, from GMP requirements to deviation management, OOS and CAPA methodologies, QRM and QMS practical implementation, qualification and validation, records and documentation practices, latest GMP training techniques and performance metrics for compliance and detailed analysis of ICH guidelines for practical implementation. This book aligns with the FDA s 21st century initiative and the ICH guidelines focused on quality risk management (ICH Q8, Q9, Q10 and Q11) and underpins the importance of science based decisions and risk evaluation as the centerpiece of compliance policy and execution. It provides a pragmatic framework for establishing a robust quality system. CONTENTS 1 Fundamentals of Global GMP Requirements 2 Effective CAPA Management for Optimal Compliance 3 Laboratory Compliance and Handling Out-of-Specification (OOS) Results in the Laboratory 4 Effectively Incorporating Quality Risk Management into Quality Systems 5 Monitoring and Controlling Process Drift for Enhancing Quality 6 Qualification and Validation 7 Process Validation 8 Documents, Records, and Part 11 Compliance 9 Change Control and Management 10 Deviation Management 11 Internal Quality Assessments/Self-Audits 12 Designing an Effective GMP Training Program 13 Behavioural GMPS (bGxP®): A New Paradigm in Compliance Management 14 Supplier Quality Management 15 Understanding the United States Pharmacopeia (USP) 16 Spotting Overall Weak GMP Compliance Systems 17 Meaningful Performance Metrics for Compliance 18 Implementing ICH Q 10: A Pragmatic Approach 19 Compliance Aspects of APIs Manufacturing 20 Compliance Aspects of Sterile Manufacturing 21 Domestic and International U.S. Food and Drug Administration (FDA) Inspections 22 Avoiding FDA Enforcement Actions: An Optimal & Sustainable Compliance Program 23 Developing a Master QMS Plan 24 Trends in cGMP Compliance Index

Achieving Quality and Compliance Excellence in Pharmaceuticals

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Books by Madhu Raju Saghee