Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control

ISBN-13: 9780081000229 / Angielski / Twarda / 2015 / 316 str.

Sandle, Tim

Opis

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

Spis treści

• Chapter 1: Introduction to Pharmaceutical Microbiology
• Chapter 2: Microbiology and Pharmaceuticals
• Chapter 3: GMP, regulations and standards
• Chapter 4: Laboratory management and design
• Chapter 5: Microbiological culture media
• Chapter 6: Basic microbiological laboratory techniques
• Chapter 7: Bioburden testing
• Chapter 8: Assessment of raw materials
• Chapter 9: Microbial identification
• Chapter 10: Assessment of pharmaceutical water systems
• Chapter 11: Endotoxin and pyrogen testing
• Chapter 12: Sterilisation and sterility assurance
• Chapter 13: Biological indicators
• Chapter 14: Antibiotic effectiveness testing and preservative efficacy testing
• Chapter 15: Disinfection
• Chapter 16: Cleanroom microbiology and contamination control
• Chapter 17: Rapid microbiological methods
• Chapter 18: Risk assessment and microbiology
• Chapter 19: Manufacturing and validation
• Chapter 20: Microbiological batch review
• Chapter 21: Microbiological audits
• Chapter 22: Microbial Challenges in the Pharmaceutical Industry
• Conclusion

O autorze

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).