Pharmaceutical Microbiology
Essentials for Quality Assurance and Quality Control

This book provides pharmaceutical microbiologists with everything they need to know, from regulatory filing and GMP information, to laboratory design and management, compendia tests, and the risk assessment tools and techniques for both sterile and non-sterile products.

Tim Sandle (Author)

9780081000229, Elsevier Science

Hardback, published 6 October 2015

316 pages
22.9 x 15.1 x 2.4 cm, 0.46 kg

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.

• 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

Subject Areas: Microbiology [non-medical PSG], Pharmacy / dispensing [MQP], Production & quality control management [KJMV5]