Rapid Microbiological Methods In The Pharmaceutical Industry
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| Author | : Martin C. Easter |
| Publisher | : CRC Press |
| Total Pages | : 197 |
| Release | : 2003-03-19 |
| Genre | : Medical |
| ISBN | : 0203010876 |
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?
| Author | : David Roesti |
| Publisher | : John Wiley & Sons |
| Total Pages | : 594 |
| Release | : 2020-01-02 |
| Genre | : Technology & Engineering |
| ISBN | : 1119356075 |
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
| Author | : Rosamund M. Baird |
| Publisher | : CRC Press |
| Total Pages | : 274 |
| Release | : 2000-08-17 |
| Genre | : Medical |
| ISBN | : 0203305191 |
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi
| Author | : Mohammed Zourob |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 980 |
| Release | : 2008-09-03 |
| Genre | : Technology & Engineering |
| ISBN | : 0387751130 |
Principles of Bacterial Detection: Biosensors, Recognition Receptors and Microsystems will cover the up-to-date biosensor technologies used for the detection of bacteria. Written by the world's most renowned and learned scientists each in their own area of expertise, Principles of Bacterial Detection: Biosensors, Recognition Receptors and Microsystems is the first title to cover this expanding research field.
| Author | : Nigel Halls |
| Publisher | : CRC Press |
| Total Pages | : 198 |
| Release | : 2016-04-19 |
| Genre | : Medical |
| ISBN | : 1420025805 |
Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisc
| Author | : Tim Sandle |
| Publisher | : Elsevier |
| Total Pages | : 510 |
| Release | : 2024-01-28 |
| Genre | : Medical |
| ISBN | : 0443216010 |
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy
| Author | : United States. Food and Drug Administration. Division of Microbiology |
| Publisher | : |
| Total Pages | : 180 |
| Release | : 1969 |
| Genre | : Microbiology |
| ISBN | : |
| Author | : National Research Council |
| Publisher | : National Academies Press |
| Total Pages | : 276 |
| Release | : 1999-01-12 |
| Genre | : Medical |
| ISBN | : 0309175771 |
The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.
| Author | : Tim Sandle |
| Publisher | : Woodhead Publishing |
| Total Pages | : 318 |
| Release | : 2015-10-09 |
| Genre | : Science |
| ISBN | : 0081000448 |
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
| Author | : Lucia Clontz |
| Publisher | : CRC Press |
| Total Pages | : 344 |
| Release | : 2008-10-14 |
| Genre | : Medical |
| ISBN | : 1420053493 |
In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c
