Rapid Microbiological Methods in the Pharmaceutical Industry

ISBN-13: 9781574911411 / Angielski / Twarda / 2003 / 288 str.

Jean Pierre Purry; Martin C. Easter

Opis

In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond? Rapid Microbiological Methods in the Pharmaceutical Industry answers these questions and more.
Martin Easter and his panel of experts:
Describe the range of rapid microbiological methods and their applications, including practical tips, and their status regarding validation, established use, and regulatory acceptance
Explore the origins of current methods and the current issues facing the requirements of microbiology and its associated test methods
Delineate the challenges involved in seeking better and more pragmatic methods for the assessment of microbial hazards and risks to ensure product and consumer safety
The book assists you in applying an effective system to assess the real microbiological hazards and, hence, quantify realistic risks. Additionally, it provides monitoring methods that will deliver meaningful, useful data for effective decision making in manufacturing, quality assurance, and product safety. The expert and authoritative information in Rapid Microbiological Methods in the Pharmaceutical Industry will help you find better solutions to ensuring the microbiological safety of pharmaceutical products.
Features"

Spis treści

FITNESS FOR A PURPOSE? TIME FOR A REVOLUTION, M.C. Easter

INTRODUCTION, M.C. Easter
Market Size
Issues and Challenges
Hopes for the Future

HISTORICAL PERSPECTIVE ON METHODS DEVELOPMENT, A.M. Cundell
Foundation of the Field of Microbiology
Development of the Classical Microbiological Methods
The Search for Rapid Biological Methods
Bibliography

MICROBIOLOGICAL METHODS OF THE PHARMACOPOEIA: GROWTH AND RECOVERY OF MICROORGANISMS FROM PHARMACEUTICAL MANUFACTURING ENVIRONMENTS, K. Haberer and M.W. Mittelman
Microbial Growth in Pharmaceutical Environments: Starvation-Survival Biofilm Formation
Influence of Environmental Conditions on Microbial Survival
Cultivation of Microorganisms on Solid and Liquid Substates
Microbiological Standard Methods of the Pharmacopoeia
References

OVERVIEW OF ALTERNATIVE RAPID MICROBIOLOGICAL TECHNOLOGIES, P.J. Newby and B. Johnson
Industrial Needs and Requirements
Rapid Methods and the Drug Development Process
Available Technologies
Molecular-Based Technologies
Identification Systems
Conclusions
References

LABOR-SAVING DEVICES AND AUTOMATION OF TRADITIONAL METHODS, P. Silley and A.N. Sharpe
Blenders, Stomachers, and Pulsifiers
Gravimetric Diluters
Counting Procedures
Some Venerable, Inexpensive, and Labor-Saving Methods
Methods for Surface Contamination: Agar Contact Methods
Spiral Plating Applications

ATP BIOLUMINESCENCE AND ITS USE IN PHARMACEUTICAL MICROBIOLOGY, K. Wills
The Science
The Products Available
References

IMPEDANCE, P. Silley and F. Mortimer
History of Development
Impedance Theory
Influence of Electrodes
Principle Factors Affecting Detection Time
Instruments
Pharmaceutical Applications of Impedance
Miscellaneous Applications in Drug Development
Conclusion
References

TRADITIONAL AND AUTOMATED RAPID METHODS FOR SPECIES IDENTIFICATION AND TYPING, K. Tyler and J.M. Farber
Genotyping
Chemotaxonomy
Electrophoretic Protein Typing
Conclusion
References

TECHNIQUES FOR DETECTION OF SPECIFIC ORGANISMS AND POTENTIAL FOR DNA-BASED TECHNOLOGIES, R. Owen
Current Established Methods for Specific Organism Detection
DNA-Based Technologies
Why Aren't More Nucleic Acid Assays Being Used?
Conclusion
References

ALTERNATIVE TECHNOLOGIES FOR STERILITY TESTING, A. Meszaros
Alternate Technologies: Clinical Origins
Alternate Technologies: Nonclinical Origins
Regulatory Acceptance and the Future for Sterility Testing
References

LIMULUS ENDOTOXIN TEST, T.J. Novitsky and H.D. Hochstein
Discovery
Early Regulatory Interest in an Alternative to the Rabbit Pyrogen Test
Commercialization
Industry Acceptance
FDA Guidelines
USP Bacterial Endotoxin Test and Related Monographs
European and Japanese Pharmacopoeia Acceptance of the LAL Test
Methodology
Automation
Research and Clinical Applications
Future of the Assay
References

A PRACTICAL GUIDE TO VALIDATION, K. Wills
What is Validation?
Background
Start at the Beginning
Specification Qualification (SQ)
Validation Plan
Design Qualification (DQ)
Operation Qualification (OQ)
Performance Qualification (PQ)
Standard Operating Procedures (SOPs)
Validation Summary
Implementation
Periodic Review
Multiple Site Validation
Amendments to Product Marketing Authorizations
Conclusion
References

REGULATORY RECOGNITION AND ACCEPTANCE, E.A. Fitzgerald
Objectives
Brief History of Regulation Development
Regulatory Concerns
Regulatory Acceptance
Summary and Conclusions
References

NEW TECHNOLOGIES FOR MICROBIOLOGICAL ASSAYS, L.J. Kricka
Immunological Tests
Cell Components
Microchips
Instrumental Techniques
Conclusions
References

AFTERWORD, M.C. Easter and A.M. Cundell
Advances in Technology
Acceptability
Attitude
References

Contributors
Index

O autorze

Martin C Easter