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Author: United States Food and Drug Administration Publisher: Createspace Independent Publishing Platform ISBN: 9781976578670 Category : Languages : en Pages : 92
Book Description
Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.
Author: United States Food and Drug Administration Publisher: Createspace Independent Publishing Platform ISBN: 9781976578670 Category : Languages : en Pages : 92
Book Description
Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.
Author: Dr. Remeth J. Dias Publisher: Trinity Publishing House, Satara ISBN: 8196569432 Category : Medical Languages : en Pages : 106
Book Description
We are very pleased to put forth the first edition of 'Laboratory Manual of Pharmaceutical Microbiology'. This manual is prepared as per PCI Education Regulations, 2014 for Degree Course in Pharmacy. This manual is designed for 'outcome-based education' and each experiment is arranged in a uniform way with respect to its practical significance, practical outcomes (PrOs) and its mapping with course outcomes, minimum theoretical background, resources used, procedure, precautions, observations, result, conclusion, references and related questions. A sincere attempt has been made through this manual to provide practical knowledge to the students about various experiments in Pharmaceutical Microbiology. The manual mainly includes the experiments through which the students will learn to prepare various culture media, isolation and propagation of pure cultures of microorganisms. The students will be proficient in handling various equipment used in microbiology laboratory. The techniques like aseptic handling, transfer of the microbial cultures, disinfection and safety measures will also be imparted to the students. The students will also be able to perform staining procedures, microbial assays, sterility testing, biochemical testing and water sample testing in the laboratory. Each experiment is divided into sections like aim, practical significance, relevant course outcomes, practical skills, relevant affective domain related outcomes, practical outcomes, minimum theoretical background, requirements, related questions, and references for further reading. The manual has been designed with more emphasis on the practical skill improvement of the students so that the students can perform the practical with ease and comfort. We are very much thankful to the designer, publisher, printers and all the stakeholders for putting their efforts for successfully bringing this manual out for the students. Hope this manual will help the students to learn the concept, principles and perform the experiments in Microbiology. We wish them all the best!!!
Author: David Roesti Publisher: John Wiley & Sons ISBN: 1119356075 Category : Technology & Engineering Languages : en Pages : 594
Book Description
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: Amita Jain Publisher: Elsevier Health Sciences ISBN: 8131253546 Category : Medical Languages : en Pages : 341
Book Description
This book is a practical manual in Microbiology for 2nd year MBBS students. There is no standard book for practical exams in the market. This book will be a student's companion in their Microbiology practical class where they can read it, do their experiments as per directions given in book, and do their assignments. It would be a 'complete practical book' with tutorials at the beginning of each chapter helping the students understand the concepts. - Integrates practical & important theoretical concepts of Microbiology - Every chapter divided in a tutorial, practical exercise, spotters and assignments - Contains easy to reproduce diagrams during the practical exams - Important case-wise Viva questions at the end of each chapter - Sample cases at the end of each chapter for understanding the correlation It would be a 'complete practical book' with tutorials at the beginning of each chapter helping the students understand the concepts.
Author: Mr. Hari Prasad Sonwani, Mrs. Sandhya Chandrakar , Ms. Aakanksha Sinha Publisher: Shashwat Publication ISBN: 9360878472 Category : Fiction Languages : en Pages : 169
Book Description
Practical microbiology is a field of study that involves the practical application of microbiology, including laboratory work, experiments, and the use of equipment: • Laboratory work This includes preparing and sterilizing equipment and culture media, preparing microbial cultures, inoculating media, incubating cultures, and sampling during growth. • Experiments Practical microbiology involves performing experiments, such as dissections and preparing permanent slides. • Equipment Practical microbiology involves using equipment such as microscopes and laboratory reagents. Some topics covered in practical microbiology include: • Identifying common microbes, their classification, and their role • Understanding how bacteria become resistant and how to test for antimicrobial susceptibility • Learning about the importance of quality management and assurance • Covering disease-causing bacteria, bacterial viruses, and the use of phage for treating diseases • Learning about the microbiome, gene editing with CRISPR, parasites, fungi, and animal viruses Some books that cover practical microbiology include: • Practical Microbiology A concise guide for students of microbiology that includes more than 230 experiments, diagrams, and viva-voce exercises Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. Practical physical pharmaceutics is a course that helps students understand the physical and physicochemical properties of dosage forms and their principles. It also helps students gain insight into the areas of pharmaceutical dosage form stability studies and formulation research and development.
Author: Stephen P. Denyer Publisher: John Wiley & Sons ISBN: 1405141034 Category : Medical Languages : en Pages : 494
Book Description
Completely revised and updated Pharmaceutical Microbiologycontinues to provide the essential resource for the 21st centurypharmaceutical microbiologist "....a valuable resource for junior pharmacists graspingan appreciation of microbiology, microbiologists entering thepharmaceutical field, and undergraduate pharmacy students." Journal of Antimicrobial Chemotherapy ".....highly readable. The content is comprehensive, withwell-produced tables, diagrams and photographs, and is accessiblethrough the extensive index." Journal of Medical Microbiology WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace ofchange in the teaching and practice of pharmaceuticalmicrobiology Expanded coverage of modern biotechnology, including genomicsand recombinant DNA technology Updated information on newer antimicrobial agents and theirmode of action Highly illustrated with structural formulas of organiccompounds and flow diagrams of biochemical processes
Author: Ian Pepper Publisher: Academic Press ISBN: 0080919405 Category : Science Languages : en Pages : 621
Book Description
For microbiology and environmental microbiology courses, this leading textbook builds on the academic success of the previous edition by including a comprehensive and up-to-date discussion of environmental microbiology as a discipline that has grown in scope and interest in recent years. From environmental science and microbial ecology to topics in molecular genetics, this edition relates environmental microbiology to the work of a variety of life science, ecology, and environmental science investigators. The authors and editors have taken the care to highlight links between environmental microbiology and topics important to our changing world such as bioterrorism and national security with sections on practical issues such as bioremediation, waterborne pathogens, microbial risk assessment, and environmental biotechnology.WHY ADOPT THIS EDITION? New chapters on: - Urban Environmental Microbiology - Bacterial Communities in Natural Ecosystems - Global Change and Microbial Infectious Disease - Microorganisms and Bioterrorism - Extreme Environments (emphasizing the ecology of these environments) - Aquatic Environments (now devoted to its own chapter- was combined with Extreme Environments) Updates to Methodologies: - Nucleic Acid -Based Methods: microarrays, phyloarrays, real-time PCR, metagomics, and comparative genomics - Physiological Methods: stable isotope fingerprinting and functional genomics and proteomics-based approaches - Microscopic Techniques: FISH (fluorescent in situ hybridization) and atomic force microscopy - Cultural Methods: new approaches to enhanced cultivation of environmental bacteria - Environmental Sample Collection and Processing: added section on air sampling
Author: Dr Mohd Mazhar, Dr Farheen , Charu Chhabra, Sayed Md Mumtaz Publisher: Shashwat Publication ISBN: 9360871710 Category : Medical Languages : en Pages : 77
Book Description
The book is primarily meant for students Pharmaceutical Microbiology . Microbiology is one of the important component of the syllabus. The main objective of this book is to help students to review their practical knowledge of Microbiology acquired through standard textbooks. A sound knowledge of Microbiology is essential for students of Medicine, Pharmacy, Dentistry & Nursing for understanding the subject with logical reasoning. This book is specially designed to complement any standard microbiology textbook and to provide the students with a feedback on their progress & an opportunity to improve. Thus the book can serve as a self assessment guide. With the explosion of knowledge in medical sciences, examinations in all faculties (Medicine, Pharmacy, Dentistry & Nursing) is completely becoming short question oriented because this system of assessment is more accurate, reliable & quicker
Author: United States Food and Drug Administration
Author: United States Food and Drug Administration
Author: Marlene Demers
Author: Dr. Remeth J. Dias 
Author: David Roesti
Author: Amita Jain
Author: United States. Food and Drug Administration. Division of Microbiology
Author: Mr. Hari Prasad Sonwani, Mrs. Sandhya Chandrakar , Ms. Aakanksha Sinha
Author: Stephen P. Denyer
Author: Ian Pepper
Author: Dr Mohd Mazhar, Dr Farheen , Charu Chhabra, Sayed Md Mumtaz