Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control
By Tim Sandle
4.5/5
()
Currently unavailable
Currently unavailable
About this ebook
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.
- Contains the applications of pharmaceutical microbiology in sterile and non-sterile products
- Presents the practical aspects of pharmaceutical microbiology testing
- Provides contamination control risks and remediation strategies, along with rapid microbiological methods
- Includes bioburden, endotoxin, and specific microbial risks
- Highlights relevant case studies and risk assessment scenarios
Tim Sandle
Dr. Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University. He has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation. Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course, and at University College, London. In addition, Dr. Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee).
Related to Pharmaceutical Microbiology
Related ebooks
Laboratory Practices in Microbiology Rating: 0 out of 5 stars0 ratingsBiocontamination Control for Pharmaceuticals and Healthcare Rating: 5 out of 5 stars5/5Multivariate Analysis in the Pharmaceutical Industry Rating: 0 out of 5 stars0 ratingsA Comprehensive Guide to Toxicology in Preclinical Drug Development Rating: 5 out of 5 stars5/5The Design and Development of Novel Drugs and Vaccines: Principles and Protocols Rating: 0 out of 5 stars0 ratingsIntroduction to Biological and Small Molecule Drug Research and Development: Theory and Case Studies Rating: 5 out of 5 stars5/5Prodrug Design: Perspectives, Approaches and Applications in Medicinal Chemistry Rating: 3 out of 5 stars3/5The Use of Mass Spectrometry Technology (MALDI-TOF) in Clinical Microbiology Rating: 0 out of 5 stars0 ratingsMicrobiology Rating: 4 out of 5 stars4/5Good Laboratory Practices and Compliance Monitoring Rating: 0 out of 5 stars0 ratingsLaboratory Methods in Microbiology Rating: 4 out of 5 stars4/5E-Z Microbiology Rating: 0 out of 5 stars0 ratingsMedical Microbiology Illustrated Rating: 4 out of 5 stars4/5Microbiology in Clinical Practice Rating: 4 out of 5 stars4/5Drug Stability for Pharmaceutical Scientists Rating: 3 out of 5 stars3/5Introduction to Quality by Design for Pharmaceuticals Rating: 0 out of 5 stars0 ratingsSterilisation and Disinfection: Pharmaceutical Monographs Rating: 5 out of 5 stars5/5A Textbook of Pharmaceutical Quality Assurance Rating: 3 out of 5 stars3/5Essential Pharmacokinetics: A Primer for Pharmaceutical Scientists Rating: 5 out of 5 stars5/5GMP in Pharmaceutical Industry: Global cGMP & Regulatory Expectations Rating: 5 out of 5 stars5/5Atkinson's Principles of Clinical Pharmacology Rating: 0 out of 5 stars0 ratingsAccelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices Rating: 5 out of 5 stars5/5Equipment Qualification in the Pharmaceutical Industry Rating: 4 out of 5 stars4/5PCR Guru: An Ultimate Benchtop Reference for Molecular Biologists Rating: 4 out of 5 stars4/5Concepts of Quality Management in Pharmaceutical Industry Rating: 0 out of 5 stars0 ratingsThe Practice of Medicinal Chemistry Rating: 4 out of 5 stars4/5Schaum's Outline of Microbiology, Second Edition Rating: 5 out of 5 stars5/5Advanced Methods in Molecular Biology and Biotechnology: A Practical Lab Manual Rating: 5 out of 5 stars5/5
Business For You
Emotional Intelligence: Exploring the Most Powerful Intelligence Ever Discovered Rating: 5 out of 5 stars5/5Productivity Hacks: 500+ Easy Ways to Accomplish More at Work--That Actually Work! Rating: 4 out of 5 stars4/5The Intelligent Investor, Rev. Ed: The Definitive Book on Value Investing Rating: 4 out of 5 stars4/5Your Next Five Moves: Master the Art of Business Strategy Rating: 5 out of 5 stars5/5Robert's Rules Of Order Rating: 5 out of 5 stars5/5Collaborating with the Enemy: How to Work with People You Don’t Agree with or Like or Trust Rating: 4 out of 5 stars4/5The Richest Man in Babylon: The most inspiring book on wealth ever written Rating: 5 out of 5 stars5/5Crucial Conversations Tools for Talking When Stakes Are High, Second Edition Rating: 4 out of 5 stars4/5How To Pay Off Your Mortgage in 5 Years Rating: 4 out of 5 stars4/5How to Write a Grant: Become a Grant Writing Unicorn Rating: 5 out of 5 stars5/5Becoming Bulletproof: Protect Yourself, Read People, Influence Situations, and Live Fearlessly Rating: 4 out of 5 stars4/5Soundtracks: The Surprising Solution to Overthinking Rating: 5 out of 5 stars5/5Tools Of Titans: The Tactics, Routines, and Habits of Billionaires, Icons, and World-Class Performers Rating: 4 out of 5 stars4/5Good to Great: Why Some Companies Make the Leap...And Others Don't Rating: 4 out of 5 stars4/5Leadership and Self-Deception: Getting out of the Box Rating: 4 out of 5 stars4/5Confessions of an Economic Hit Man, 3rd Edition Rating: 5 out of 5 stars5/5Summary of J.L. Collins's The Simple Path to Wealth Rating: 5 out of 5 stars5/5Crucial Conversations: Tools for Talking When Stakes are High, Third Edition Rating: 4 out of 5 stars4/5Capitalism and Freedom Rating: 4 out of 5 stars4/5Set for Life: An All-Out Approach to Early Financial Freedom Rating: 4 out of 5 stars4/5Financial Words You Should Know: Over 1,000 Essential Investment, Accounting, Real Estate, and Tax Words Rating: 4 out of 5 stars4/5Grant Writing For Dummies Rating: 5 out of 5 stars5/5Robert's Rules of Order: The Original Manual for Assembly Rules, Business Etiquette, and Conduct Rating: 4 out of 5 stars4/5The Five Dysfunctions of a Team: A Leadership Fable, 20th Anniversary Edition Rating: 4 out of 5 stars4/5Lying Rating: 4 out of 5 stars4/5Buy, Rehab, Rent, Refinance, Repeat: The BRRRR Rental Property Investment Strategy Made Simple Rating: 5 out of 5 stars5/5
Related categories
Reviews for Pharmaceutical Microbiology
6 ratings0 reviews