Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control

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9780081000229: Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control

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

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About the Author:

Tim Sandle is Head of Microbiology at the Bio Products Laboratory, Elstree, UK and a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, Manchester University, UK.

"About this title" may belong to another edition of this title.

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Book Description ELSEVIER SCIENCE TECHNOLOGY, United Kingdom, 2015. Hardback. Book Condition: New. 229 x 152 mm. Language: English . Brand New Book. 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. Bookseller Inventory # AAC9780081000229

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Book Description ELSEVIER SCIENCE TECHNOLOGY, United Kingdom, 2015. Hardback. Book Condition: New. 229 x 152 mm. Language: English . Brand New Book. 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. Bookseller Inventory # AAC9780081000229

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Book Description Book Condition: New. Publisher/Verlag: Woodhead Publishing | Essentials for Quality Assurance and Quality Control | 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 productsPresents the practical aspects of pharmaceutical microbiology testingProvides contamination control risks and remediation strategies, along with rapid microbiological methodsIncludes bioburden, endotoxin, and specific microbial risksHighlights relevant case studies and risk assessment scenarios | Chapter 1: Introduction to Pharmaceutical MicrobiologyChapter 2: Microbiology and PharmaceuticalsChapter 3: GMP, regulations and standardsChapter 4: Laboratory management and designChapter 5: Microbiological culture mediaChapter 6: Basic microbiological laboratory techniquesChapter 7: Bioburden testingChapter 8: Assessment of raw materialsChapter 9: Microbial identificationChapter 10: Assessment of pharmaceutical water systemsChapter 11: Endotoxin and pyrogen testingChapter 12: Sterilisation and sterility assuranceChapter 13: Biological indicatorsChapter 14: Antibiotic effectiveness testing and preservative efficacy testingChapter 15: DisinfectionChapter 16: Cleanroom microbiology and contamination controlChapter 17: Rapid microbiological methodsChapter 18: Risk assessment and microbiologyChapter 19: Manufacturing and validationChapter 20: Microbiological batch reviewChapter 21: Microbiological auditsChapter 22: Microbial Challenges in the Pharmaceutical IndustryConclusion | Format: Hardback | Language/Sprache: english | 641 gr | 242x167x17 mm | 316 pp. Bookseller Inventory # K9780081000229

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