Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries PDF Download
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Author: R. Baird
Publisher: CRC Press
ISBN: 1135743630
Category : Science
Languages : en
Pages : 272
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Book Description
The importance of quality assurance in the production, storage and use of manufactured preparations is widely recognized. This book encapsulates the issues involved in the manufacture of non-steriles, such as creams, ointments, herbal remedies, shampoos, soaps and toiletry products (as opposed to sterile drugs and injectible products). Knowledge of the microbial limits is expanded, new standards are included, and coverage of the preservation issues of dosage forms is widened to include semi-solids and liquid preparations. This edition also contains new regulations regarding preservative efficacy testing and covers pharmacopoeial and industry regulations and guidelines. Rapid methods are also discussed, now more common in cosmetic and toiletry practice, in their pharmaceutical capacity.
Author: R. Baird
Publisher: CRC Press
ISBN: 1135743630
Category : Science
Languages : en
Pages : 272
Get Book Here
Book Description
The importance of quality assurance in the production, storage and use of manufactured preparations is widely recognized. This book encapsulates the issues involved in the manufacture of non-steriles, such as creams, ointments, herbal remedies, shampoos, soaps and toiletry products (as opposed to sterile drugs and injectible products). Knowledge of the microbial limits is expanded, new standards are included, and coverage of the preservation issues of dosage forms is widened to include semi-solids and liquid preparations. This edition also contains new regulations regarding preservative efficacy testing and covers pharmacopoeial and industry regulations and guidelines. Rapid methods are also discussed, now more common in cosmetic and toiletry practice, in their pharmaceutical capacity.
Author: Donald S. Orth
Publisher: Allured Books
ISBN: 9781932633627
Category : Cosmetics
Languages : en
Pages : 0
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Book Description
Author: United States. Food and Drug Administration. Division of Microbiology
Publisher:
ISBN:
Category : Microbiology
Languages : en
Pages : 180
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Book Description
Author: Daniel K. Brannan
Publisher: CRC Press
ISBN: 9780849337130
Category : Medical
Languages : en
Pages : 340
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Book Description
Until now, information on cosmetic microbiology was scattered and mostly consisted of oral tradition passed on from mentors to apprentices. Finally, here is an understandable and easy-to-read guide documenting cosmetic microbiology practices. Cosmetic Microbiology: A Practical Handbook contains technical information on sanitation and the preservation of cosmetics for microbiologists as well as for process engineers, plant managers, and workers. The book provides the knowledge needed to create safe and usable cosmetic products. All aspects of cosmetic microbiology are covered, including testing methods, preservation, toxicology, and regulatory concerns.
Author: Philip A. Geis
Publisher: CRC Press
ISBN: 0429524439
Category : Medical
Languages : en
Pages : 290
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Book Description
This updated edition provides research scientists, microbiologists, process engineers, and plant managers with an authoritative resource on basic microbiology, manufacturing hygiene, and product preservation. It offers a contemporary global perspective on the dynamics affecting the industry, including concerns about preservatives, natural ingredients, small manufacturing, resistant microbes, and susceptible populations. Professional researchers in the cosmetic as well as the pharmaceutical industry will find this an indispensable textbook for in-house training that improves the delivery of information essential to the development and manufacturing of safe high-quality products
Author: United States Food and Drug Administration
Publisher: Createspace Independent Publishing Platform
ISBN: 9781976578670
Category :
Languages : en
Pages : 92
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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: Amparo Salvador
Publisher: Elsevier
ISBN: 0444635165
Category : Technology & Engineering
Languages : en
Pages : 632
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Book Description
Analysis of Cosmetic Products, Second Edition advises the reader from an analytical chemistry perspective on the choice of suitable analytical methods for production monitoring and quality control of cosmetic products. This book helps professionals working in the cosmetic industry or in research laboratories select appropriate analytical procedures for production, maintain in-market quality control of cosmetic products and plan for the appropriate types of biomedical and environmental testing. This updated and expanded second edition covers fundamental concepts relating to cosmetic products, current global legislation, the latest analytical methods for monitoring and quality control, characterization of nanomaterials and other new active ingredients, and an introduction to green cosmetic chemistry. - Provides comprehensive coverage of the specific analytical procedures for different analytes and cosmetic samples - Includes information on the biomonitoring of cosmetic ingredients in the human body and the environment - Describes the most recent developments in global legislation governing the cosmetics industry - Introduces green technologies and the use of nanomaterials in the development and analysis of cosmetic ingredients
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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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: H.W. Rossmoore
Publisher: Springer Science & Business Media
ISBN: 9401113548
Category : Technology & Engineering
Languages : en
Pages : 437
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Book Description
My professional interest in antimicrobial agents and contamination control goes back 50 years to my tour as a microbiologist in a field hospital in Europe during World War II. With no experience and relying solely on a military handbook, I prepared thermometer trays with jars of blue bichloride of mercury and pink isopropyl alcohol. A preliminary typhoid diagnosis of one of our cooks resulted in the need for lab testing. His stool specimen and its subsequent disposal was my problem. My handbook said bum it. So burn it T did, in a five-gallon can with gasoline. Flames shot up almost six feet, and my next mistake was to extinguish them with carbon tetrachloride. This resulted in the production of lethal phosgene gas. The hospital had a near disaster. I could say that at that moment I vowed to write a how-to book so that such stupidities could be avoided. Nevertheless, when I was offered the opportunity to edit this book I thought back on the need for a real, practical treatment of my subject. This book, then, is a practical handbook for technical service personnel and scientists who are not necessarily specialists in microbiology. It provides information on suitable antimicrobial agents appropriate to their particular problem-solving needs and information on the microbial groups contributing to the specific problem, their ecologies, and strategies for controlling their access to the area or material of interest.
Author: Lucia Clontz
Publisher: CRC Press
ISBN: 1420053493
Category : Medical
Languages : en
Pages : 344
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Book Description
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
