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Pharmaceutical Microbiology

Pharmaceutical Microbiology Author Tim Sandle
ISBN-10 9780081000441
Release 2015-10-09
Pages 316
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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



Pharmaceutical Microbiology

Pharmaceutical Microbiology Author Tim Sandle
ISBN-10 0081000227
Release 2015-10-15
Pages 316
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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



Pharmaceutical Microbiology Essentials for Quality Assurance and Quality Control

Pharmaceutical Microbiology  Essentials for Quality Assurance and Quality Control Author
ISBN-10 OCLC:972008581
Release
Pages
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Pharmaceutical Microbiology Essentials for Quality Assurance and Quality Control has been writing in one form or another for most of life. You can find so many inspiration from Pharmaceutical Microbiology Essentials for Quality Assurance and Quality Control also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Pharmaceutical Microbiology Essentials for Quality Assurance and Quality Control book for free.



Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices

Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices Author
ISBN-10 8190646745
Release 2011
Pages 964
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Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices has been writing in one form or another for most of life. You can find so many inspiration from Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices book for free.



Hugo and Russell s Pharmaceutical Microbiology

Hugo and Russell s Pharmaceutical Microbiology Author Stephen P. Denyer
ISBN-10 9781118293829
Release 2011-11-22
Pages 456
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Pharmaceutical microbiology has a bearing on all aspects of pharmacy, from the manufacture and quality control of pharmaceutical products through to an understanding of the mode of action of antibiotics. Fully revised and restructured, drawing on the contributions of subject experts, and including material relevant to the European curricula in pharmacy, the eighth edition covers: biology of micro-organisms pathogens and host response prescribing therapeutics contamination and infection control pharmaceutical production current trends and new directions Hugo and Russell’s Pharmaceutical Microbiology, a standard text for Schools of Pharmacy for seven editions, continues to be a user-friendly and authoritative guide for both students and practitioners of pharmacy and pharmaceutical microbiology. 'Highly Commended' in the Pharmacology section of the 2012 BMA Book Awards



Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices Author Rosamund M. Baird
ISBN-10 0203305191
Release 2003-09-02
Pages 280
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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 providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text. The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.



Quality Assurance of Aseptic Preparation Services

Quality Assurance of Aseptic Preparation Services Author Alison M. Beaney
ISBN-10 0853696152
Release 2006
Pages 154
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It is now widely recognised that preparation of intravenous injections should be carried out in pharmacy departments rather than on wards, using defined standards. This new edition of Quality Assurance of Aseptic Preparation Services provides information and up-to-date national guidance on unlicensed aseptic preparation.



Pharmaceutical Process Design and Management

Pharmaceutical Process Design and Management Author Kate McCormick
ISBN-10 9781317081401
Release 2016-04-22
Pages 288
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A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.



Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals Author Tim Sandle
ISBN-10 9781908818638
Release 2013-10-31
Pages 362
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Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products



Quality Assurance of Pharmaceuticals

Quality Assurance of Pharmaceuticals Author World Health Organization
ISBN-10 9789241547086
Release 2007-01-01
Pages 409
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Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.



The CDC Handbook A Guide to Cleaning and Disinfecting Clean Rooms

The CDC Handbook   A Guide to Cleaning and Disinfecting Clean Rooms Author Dr. Tim Sandle
ISBN-10 9781781480809
Release 2012-08-02
Pages 300
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The Cleaning and Disinfection handbook is aimed at those working within the pharmaceutical and healthcare sectors around the world, as well as providing valuable information for students and for the general reader. The book provides comprehensive detail on different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations; expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards. The book also provides guidance on disinfectant efficacy testing. Assembled by expert practitioners, the book balances theoretical concepts with sound practical advice, and is likely to become the definitive text on keeping contamination in control within clean areas and controlled environments. With this second edition, the book is fully updated in line with the latest standards and regulations.



The Quality Control of Medicines

The Quality Control of Medicines Author P.B. Deasy
ISBN-10 9781483165028
Release 2014-05-21
Pages 412
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The Quality Control of Medicines documents the proceedings of the 35th International Congress of Pharmaceutical Sciences, organized by the Pharmaceutical Society of Ireland on behalf of the Federation Internationale Pharmaceutique, held in Dublin, on 1-5 September 1975. The theme chosen for the Congress was ""the basis for the quality control of medicines"", because of the importance and relevance of quality control in the production and distribution of medicines at national and international levels. This volume is arranged according to the manner in which the theme of the Congress was developed by the eminent invited speakers. Following the inaugural address a main symposium was held where five speakers presented a review of the quality control of medicines under the general headings of (i) chemical and physical aspects; (ii) biological aspects; (iii) control of drug delivery systems; (iv) storage problems; and (v) problems of international control. Certain aspects of the content of the main symposium were then developed in greater depth in parallel symposia. In the first parallel symposium some novel physicochemical aspects of the quality control of medicines were treated under the headings of spectrofluorimetry, mass spectrometry, detection in gas chromatography, and automation in pharmaceutical analysis. The second parallel symposium developed certain microbiological aspects of quality control under the headings of sterility testing and microbiological control of non-sterile products and ophthalmic preparations. The final symposium on submissions to regulatory bodies and international aspects of drug control covered aspects of politics in submissions, regulatory problems in small countries, and various pharmacopoeial problems.



Textbook of Pharmaceutical Biotechnology E Book

Textbook of Pharmaceutical Biotechnology   E Book Author Chandrakant Kokate
ISBN-10 9788131239872
Release 2016-04-27
Pages 350
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Textbook of Pharmaceutical Biotechnology - E-Book



Handbook of Water Purity and Quality

Handbook of Water Purity and Quality Author Satinder Ahuja
ISBN-10 0080921124
Release 2009-07-17
Pages 412
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This work provides those involved in water purification research and administration with a comprehensive resource of methods for analyzing water to assure its safety from contaminants, both natural and human caused. The book first provides an overview of major water-related issues in developing and developed countries, followed by a review of issues of sampling for water analysis, regulatory considerations and forensics in water quality and purity investigations. The subsequent chapters cover microbial as well chemical contaminations from inorganic compounds, radionuclides, volatile and semi-volatile compounds, disinfectants, herbicides, and pharmaceuticals, including endocrine disruptors, as well as potential terrorist-related contamination. The last chapter describes the Grainger prize-winning filter that can remove arsenic from water sources and sufficiently protect the health of a large number of people. - Covers the scope of water contamination problems on a worldwide scale - Provides a rich source of methods for analyzing water to assure its safety from natural and deliberate contaminants - Describes the filter that won the $1 million Grainger prize and thereby highlighting an important approach to remediation



Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook Author Shayne Cox Gad
ISBN-10 0470259825
Release 2008-04-04
Pages 832
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With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.



Total Quality Management

Total Quality Management Author D.R Kiran
ISBN-10 9780128110362
Release 2016-10-28
Pages 580
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Total Quality Management: Key Concepts and Case Studies provides the full range of management principles and practices that govern the quality function. The book covers the fundamentals and background needed, as well as industry case studies and comprehensive topic coverage, making it an invaluable reference to both the novice and the more experienced individual. Aspects of quality control that are widely utilized in practice are combined with those that are commonly referred to on University courses, and the latest developments in quality concepts are also presented. This book is an ideal quick reference for any manager, designer, engineer, or researcher interested in quality. Features two chapters on the latest ISO standards Includes an introduction to statistics to help the reader fully grasp content on statistical quality control Contains case studies that explore many TQM themes in real life situations



The International Pharmacopoeia

The International Pharmacopoeia Author World Health Organization
ISBN-10 9789241563017
Release 2006
Pages 1499
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The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. This new edition consolidates the texts of the five separate volumes of the third edition and includes new monographs for antiretroviral substances (didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate) adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004. It includes some additions and amendments to the general notices of the Pharmacopoeia, as well as some changes to its layout and format. Volume one contains monographs for pharmaceutical substances A to O and the General Notices; and volume two contains monographs for pharmaceutical substances P to Z, together with those for dosage forms and radiopharmaceutical preparations, the methods of analysis and reagents.