International Biotechnology, Bulk Chemical, and Pharmaceutical GMPs

International Biotechnology, Bulk Chemical, and Pharmaceutical GMPs, Fifth Edition

Description:

This book contains the English language texts of all GMPs, regulations, guidelines, codes, and practices implemented by national and international regulatory authorities that govern the manufacture and testing of biotechnology-derived products, active pharmaceutical ingredients, and pharmaceuticals. Prepared with the cooperation of health authorities worldwide, this resource contains the GMPs in effect in 114 countries, plus GMP regulations of the World Health Organization, including the 1996 WHO GMPs, the European Union, the Association of South East Asian Nations, and the Pharmaceutical Inspection Convention.

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PART - 1

PART - 2

Significant Pharmaceuticals Reported in US Patents

Significant Pharmaceuticals Reported in US Patents
By Thomas F. DeRosa

Description:
This book identifies the next generation of pharmaceuticals reported in US Patents. This "hands-on" title provides explicit laboratory methods for preparing the most recent and effective medications. Each entry documents the biological testing protocols used to evaluate a drug and the significance of the current treatment agent over previous methods. Pharmaceuticals are included in this review only if at least two of the following criteria were met: Effectiveness in treating an illness, Innovative, ease of preparation, synergy with existing Medications.
Pharmaceuticals are reported for 27 separate classes of illness, including;
AIDS, Alzheimer's Disease, Cardiovascular Disorders, Diabetes, Epilepsy, Hepatitis C, Osteoporosis, Obesity and Sleep Disorders.
Significant Pharmaceuticals Reported in US Patents has been designed to be used as both a reference and synthetic guide for pharmaceutical, medicinal and organic chemists and graduate students.
Researchers working in other areas will also find the information valuable as in many instances intermediates or the next generation pharmaceutical are readily convertible into other industrial products including: anti-oxidants, chemical additives, herbicides, polymer precursors, water purification agents. Clear structural depictions of reagents and chemical transformations have been supplied to permit the identification of other future applications.

* Identifies next generation pharmaceuticals
* Provides practical preparation methods for each active agent and derivatives
* Documents the analytical characterization and biological testing results of active agents.

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Transport Processes in Pharmaceutical Systems

Transport Processes in Pharmaceutical Systems
By Gordon L. Amidon, Ping I. Lee, Elizabeth M. Topp

Description:

This cutting-edge reference clearly explains pharmaceutical transport phenomena, demonstrating applications ranging from drug or nutrient uptake into vesicle or cell suspensions, drug dissolution and absorption across biological membranes, whole body kinetics, and drug release from polymer reservoirs and matrices to heat and mass transport in freeze-drying and hygroscopicity. Focuses on practical applications of drug delivery from a physical and mechanistic perspective, highlighting biological systems. Written by more than 30 international authorities in the field, Transport Processes in Pharmaceutical Systems · discusses the crucial relationship between the transport process and thermodynamic factors · analyzes the dynamics of diffusion at liquid-liquid, liquid-solid, and liquid-cultured cell interfaces · covers prodrug design for improving membrane transport · addresses the effects of external stimuli in altering some natural and synthetic polymer matrices · examines properties of hydrogels, including synthesis, swelling degree, swelling kinetics, permeability, biocompatibility, and biodegradability · presents mass transfer of drugs and pharmacokinetics based on mass balance descriptions · and more! Containing over 1000 references and more than 1100 equations, drawings, photographs, micrographs, and tables, Transport Processes in Pharmaceutical Systems is a must-read resource for research pharmacists, pharmaceutical scientists and chemists, chemical engineers, physical chemists, and upper-level undergraduate and graduate students in these disciplines.

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Cleanroom Technology: Fundamentals of Design, Testing and Operation

Cleanroom Technology: Fundamentals of Design, Testing and Operation
By W. Whyte

Description:

A cleanroom is a contamination-controlled environment and is essential in the industrial manufacture of many electronic, semiconductor, optical, pharmaceutical and medical products.

The use of cleanrooms for the manufacture of a large range of products such as microprocessors, CD players, lasers, pharmaceuticals and medical devices continues to grow and many companies are using cleanrooms for the first time. At the same time, new technology products that can only be produced in cleanrooms are being developed. This comprehensive overview of the fundamentals, design, testing and operation of cleanroom systems provides novices with a introduction to this state-of-the-art technology and professionals with an accessible reference to the current standards. Readers will benifit from the author's 35 years of experience in cleanroom technology R&D, consultancy and teaching. The text is complementary to the structure and content of Whyte's own and many in-house cleanroom courses in the electronics and pharmaceutical industries.
· Complementary to the highly successful Cleanroom Design, Second Edition and the forthcoming Cleanroom Testing and Running by the same author
· Presents the fundamentals and latest standards for the design, validation, testing and running of cleanroom systems
Pitched at introductory level and tailored to fulfil the training requirements of scientists and engineers new to cleanroom technology.

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Isolation Technology: A Practical Guide

Isolation Technology: A Practical Guide, Second Edition
By Tim Coles

Description:

The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology. Here's what's new in the Second Edition: " Descriptions of and comments on new guidelines and standards " Technological advances - such as the new breed of sanitizing gas generators " Updates that reflect current thinking and new information Drawing on his vast experience in this field, the author delineates practical ways to improve product standards, increase operator productivity, efficiency and safety, and cut costs. Carefully designed for easy understanding by readers from multiple fields, the book reviews the how-tos for setting up clean rooms and techniques for maintaining sterility, and includes case studies, resource listings, and numerous photographs. The combination of up-to-date information and the author's clear writing style make this the ideal resource for both experienced and beginning professionals.

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Drug Stability: Principles and Practices

Drug Stability: Principles and Practices
By Jens T. Carstensen, C.T. Rhodes

Description:

Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.

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Spectroscopy of Pharmaceutical Solids

Spectroscopy of Pharmaceutical Solids
By Harry G. Brittain

Description:
Selecting illustrative examples from the recent literature, this reference studies the underlying principles and physics of a wide range of spectroscopic techniques utilized in the pharmaceutical sciences and demonstrates various applications for each method analyzed in the text-showing how knowledge of the mechanisms of spectroscopic phenomena may facilitate more advanced technologies in the field.

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The Pharmaceutical Regulatory Process

The Pharmaceutical Regulatory Process
By Ira R. Berry

Description:

Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.

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Environmental Management Plans Demystified: A Guide to ISO 14001

Environmental Management Plans Demystified: A Guide to ISO 14001
By Stephen Tinsley

Description:

The drivers of consumer pressure and environmental awareness are forcing businesses to take a more critical view of their environmental management procedures. The development of an environmental management plan is an essential business activity that helps organize, direct and control operational activities, and plan for future environmental risk. Tinsley presents the process and procedures in a clear and accessible style, providing guidelines for plan creation and implementation. Examples of standard documentation, case studies, time tables, and checklists are included.

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Write It Down: Guidance for Preparing Documentation that Meets Regulatory Requirements

Write It Down: Guidance for Preparing Documentation that Meets Regulatory Requirements
By Janet Gough

Description:

A well-understood tenet exists among the FDA and other regulatory bodies: if it isn't written down, it didn't happen! And if it didn't happen, companies stand to lose time, money, and perhaps their competitive edge. This book provides writers with the tools they need to put effective documentation in place. It offers a broad range of documents representative of the types of writing in the healthcare industry, from the laboratory to QA to manufacturing and regulatory affairs. The book offers valuable insights into managing systems and producing documentation that meets the requirements of both the FDA and ISO 9000.

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A Practical Handbook of Preparative HPLC

A Practical Handbook of Preparative HPLC
By Donald A. Wellings

Description:

This book is a distillation of twenty years of practical experience of the high pressure liquid chromatography (HPLC) process. Deliberately steering clear of complex theoretical aspects, this book concentrates on the everyday problems associated with the technique, making it perfect for frequent use in the laboratory and for those in the pharmaceutical, agrochemical and biotechnology industries for the analysis and purification of drugs, small molecules, proteins and DNA.

This book Provides practical, hands-on advice based on years of experience
Will help ensure optimal design, equipment and separation results for your particular task
Presents system layouts from laboratory to process scale
Will help you to devise or improve record-keeping and documentation systems

·Provides practical, hands-on advice based on years of experience
·Will help ensure optimal design, equipment and separation results for your particular task
·Presents system layouts from laboratory to process scale
·Will help you to devise or improve record-keeping and documentation systems.

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Pharmaceutical Engineering Change Control

Pharmaceutical Engineering Change Control
By Simon G. Turner

Description:

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control training. It gives readers a toolbox for ensuring that adequate controls are implemented.

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Drug Facts and Comparisons 2007

Drug Facts and Comparisons 2007

Description:

Drug Facts and Comparisons contains up-to-date, comprehensive information on over 22,000 Rx and almost 6,000 OTC items grouped by therapeutic category for ease of comparison. The annual hardbound edition features the Color Locator, a full-color section of photos of the most frequently prescribed tablets and capsules organized by color for easy visual identification. The book answers questions about: actions, indications and contraindications; warnings and precautions; interactions between drugs; adverse reactions; administration, dosage, and overdosage; patient information. Comparisons are provided: Of drug to drug; of different dosage forms; name brands are compared to name brands and to generics. Facts and Comparisons are also given on Centers for Disease Control biologicals and antiparasitic drugs; IV solutions; therapeutic and diagnostic ophthalmic preparations; diagnostic aids and radiographic contrast media and products; NCI investigational chemotherapeutic drugs; combination cancer chemotherapy regimens.

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A to Z Drug Facts

A to Z Drug Facts

Description:

Annual pocket-sized reference presents the newest FDA approvals, latest indications, dosages, side effects, and patient care considerations. Includes current data on more than 3,000 drugs. RX, over-the-counter, and investigational and orphan drugs are also included as well as protocols and guidelines.

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British National Formulary 52

British National Formulary 52

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Pharmaceutical Chemical Analysis: Methods for Identification and Limit Tests

Pharmaceutical Chemical Analysis: Methods for Identification and Limit Tests
By Ole Pedersen

Description:

With the scarce availability of current information on European Pharmacopoeia testing methods, this text explains the purpose, chemistry involved, and of analytical tests behind these older, yet standard tests. Often cheaper, simpler, and as reliable as newer tests, this book covers the identification of ions, functional groups tests, and limit tests. It explains the logic of the individual procedural steps of the test with formulas,reaction, and tips on the strengths and weaknesses of these techniques in terms of specificity, ruggedness, and potential procedural pitfalls. The book contains approximately 200 illustrations, 146 equations, and 6 tables that shed light on the concepts in the text.

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The Laboratory Quality Assurance System:A Manual of Quality Procedures and Forms

The Laboratory Quality Assurance System:A Manual of Quality Procedures and Forms
By Thomas A. Ratliff

Description:
Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual:

-Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories.
-Provides blank forms used in preparing a quality manual.
-Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000.

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Good Laboratory Practice

Good Laboratory Practice: the Why and the How
By Jurg P. Seiler

Description:

The second edition of this concise hands-on guide to implementing Good Laboratory Practice standards has been fully updated to include the latest changes in the regulatory framework. Particularly the areas of in vitro testing and multi-site studies have undergone considerable developments in recent years.

This practice-oriented guide introduces the reader to the background, basic principles, operating procedures and OECD standards. It gives invaluable information on how to avoid pitfalls and save precious time and resources. It will be an essential acquisition for anyone concerned with modern GLP.

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GLP Quality Audit Manual

GLP Quality Audit Manual, Third Edition
By Milton A. Anderson

Description:

Designed to enable readers to plan and execute their own audits, this comprehensive guide presents discussions of and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section Ill comprises the full texts of the relevant standards and regulations along with the Priniciples of Good Laboratory Practice.

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Six Sigma for Marketing Processes : An Overview for Marketing Executives, Leaders, and Managers

Six Sigma for Marketing Processes : An Overview for Marketing Executives, Leaders, and Managers
By Clyde M. Creveling, Lynne Hambleton, Burke McCarthy

Prentice Hall PTR
ISBN: 013199008X
Pages: 304
4.2 Mb

Description:

This book provides an overview of the way marketing professionals can utilize the value offered by Six Sigma tools, methods, and best practices, within their existing phase-gate processes, as well as the traditional Six Sigma problem-solving approach: define, measure, analyze, improve, control (DMAIC). It provides unique methods for employing Six Sigma to enhance the three marketing processes for enabling a business to attain growth: strategic, tactical, and operational.

It goes further to demonstrate the way Six Sigma for marketing and Six Sigma for design can be combined into a unified Six Sigma for growth. In this book, you’ll learn how to apply Six Sigma methodology to

* Develop a lean, efficient marketing workflow designed for growth
* Enhance the three marketing arenas for growth: strategic, tactical, and operational
* Identify leading indicators of growth and become proactive about performance improvement
* Strengthen links between customers, products, and profitability
* Redesign marketing work to streamline workflow and reduce variability
* Assess and mitigate cycle-time risk in any marketing initiative or project
* Leverage DMAIC to solve specific problems and improve existing processes

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OR
MIRROR

Silicone Elastomers (Rapra Review Reports)

Silicone Elastomers (Rapra Review Reports)
by Peter Jerschow

Publisher: Smithers Rapra Technology
ISBN: 1859572979
Pages: 172
PDF: 1.9 MB

Description:
Silicone elastomers are important materials for many application areas such as automotive, electric and electronics, domestic appliances and medical. They are increasingly being used to substitute for organic rubbers, because of their advantageous properties.

This is a very comprehensive review of the state-of-the-art in silicone elastomers.

It deals with the advantages of using silicone rubbers, such as high temperature and chemical resistance, pigmentability and transparency, combined with good electrical properties.

It describes processing by extrusion, injection moulding and calendering, and the use of silicones in flexible and rigid mould making. The key issues concerning the processing of silicones are addressed here.

The key material types and the nomenclature used to describe silicones are explained. Room temperature vulcanised (RTV), high temperature vulcanised (HTV) and liquid silicone rubbers (LSR) are all discussed.

Speciality silicones are continually being developed to meet specific application requirements, for example, standard silicone is a good electrical insulator and is used in cable coverings, however, conductive silicones are now available. These new grades of silicones are described and compared to standard grades for key performance issues.

This review is packed with details on specific silicone materials, containing over 50 tables of information together with useful graphs. It is much longer than the usual reviews in this series.

The review is accompanied by around 400 abstracts from the Rapra Abstracts database, to facilitate further reading on this subject.

Key features…
* Applications
* Property requirements of applications
* Properties of standard and speciality elastomers
* Basic chemistry
* Curing
* Processing
* Useful tables of data

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ISO 14001 Environmental Systems Handbook

ISO 14001 Environmental Systems Handbook
By Ken Whitelaw

Description:

ISO 14001 Environmental Systems Handbook Second Edition outlines the scope and purpose of the standard, making it accessible to all.

The author begins by explaining the concepts of the standard, which sets the tone for a practical guide to implementation of an ISO 14000-compliant environmental management system, which also covers the consultant's and auditor's perspective.

The case studies from industries that have actually undergone the process have been updated to include information on their progress toward environmental objectives in the 18-24 months following implementation. A new case study from a service organisation ( a car lease company) will be added. Finally there is input from training organisations and certification and accreditation bodies to assist with trouble-shooting and assessment. Additional information is also included on international legislative issues. Comparisons with ISO 9000 will also be fully updated to reflect revisions to this standard.


The book will offer the reader a range of options for implementation, and guidance on which is the best option to suit the particular organisation's culture.

* Fully updated to meet the new 2004 amendments to ISO 14001
* New case studies to show how ISO14001 is being implemented and is working for key organisations
* Proven track record of making understanding and implementing ISO14001 accessible

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Environmental management system ISO 14001

Environmental management system ISO 14001

Description:

Environmental management system ISO 14001 -35 searching questions and contrasting pairs of examples The book is intended as a guide and work book for people taking part in a self evaluation process. The book describes the contents of the ISO 14001 standard using 35 questions and contrasting pairs of examples. The book can be used to help you understand the standard without any training. The book can be used to identify areas for development by comparing your own practices with those stipulated in the standard. The examples in the book help the self evaluation participants to understand what each of the questions means. For every question, an evaluation is made of its importance, as well as its current and target performance capability, on a scale of 1 - 5. The self assessment question form can be opened in the screen and filled out while reading the book. After filling in all the questions the result can be printed out. You do not need to be familiar with the ISO 14001 standard in order to answer the questions, just give your evaluation on the basis of your own imagination. The book’s job is to help you develop your imagination. The book, questions and self evaluation process can be adapted as a development tool and training material for the organisation even if the organisation does not adopt the ISO 14001 standard.

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Microbiological Contamination Control in Pharmaceutical Clean Rooms

Microbiological Contamination Control in Pharmaceutical Clean Rooms
By Nigel Halls

Description:

This book neatly clarifies some of the perceived problems surrounding contamination control in pharmaceutical industry clean rooms. It helps manufacturers satisfy both domestic and international regulations and prevent their companies from suffering the consequences of non-compliance. It includes up-to-date information on microbiological contamination in sterile manufacturing, microbiological media fills, microbiological environmental monitoring, control in aqueous-based, non-sterile pharmaceuticals, rapid testing methods, and clean room contamination control. This book is an important resource for the microbiologist working in pharmaceutical manufacturing.

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Validation of Pharmaceutical Processes: Sterile Products

Validation of Pharmaceutical Processes: Sterile Products, Second Edition, Revised and
By Frederick J. Caleton, James P. Agalloco

Description:

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program and suggested the solutions.

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Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification

Description:

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

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Analytical Method Development and Validation

Analytical Method Development and Validation
By Michael E. Swartz, Ira S. Krull

Description:

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

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Pharmaceutical Dissolution Testing

Pharmaceutical Dissolution Testing
By Jennifer Dressman, Johannes Kramer

Description:

An expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms, this reference provides reader-friendly chapters on currently utilized equipment, equipment qualification, consideration of the gastrointestinal physiology in test design, the analysis and interpretation of data and procedure automation -laying the foundation for the creation of appropriate and useful dissolution tests according to the anticipated location and duration of drug release from the dosage form within the gastrointestinal tract.

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Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical
By Guy Wingate

Description:

The most comprehensive guide to computer validation currently available, this invaluable reference discusses good laboratory, clinical, manufacturing, and distribution practices and explains the latest regulatory developments for the US, European and other regulatory authorities. Practical examples and checklists appear throughout the book and the authors explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. He reviews over twenty case studies of different types of computer systems. Latest FDA and PIC/S developments concerning computer validation, electronic records and signatures, and process analytical technologies are included.

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Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
By Sarfaraz K. Niazi

Description:

Essentially a cookbook for making drugs, the six-volume handbook contains the recipes and process steps for over 2000 drugs, including a number of biotechnology drugs. The author has painstakingly assembled these volumes from FDA New Drug Applications, patent applications, and the BASF book of generic formulations, all supplemented by his 30-plus years of experience in pharmaceutical formulations. Each entry begins with a fully validated scaleable master manufacturing formula that includes the compendial specification requirement for each ingredient, process controls for manufacturing and release of the product, a summary of manufacturing process, and more.

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Quality Assurance of Pharmaceuticals

Quality Assurance of Pharmaceuticals

Description:

The second volume of the Compendium on quality assurance of pharmaceuticals has been updated to include all new and revised texts published by WHO through the end of 2003 in the area of good manufacturing practices (GMP), inspection and the use of risk analysis in production of pharmaceuticals. All together it includes 15 different guidance texts which were all adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. The texts have been developed, revised and reviewed in a consultative process through participation of members of WHO expert panels, specialists, international professional associations , institutions, international organizations, NGOs and other third parties recognized as being competent in this field.

The texts cover good manufacturing practices and inspection of production sites and distribution channels, as well as the quality system requirements of national GMP inspectorates. The good manufacturing practices include main principles as well as supplementary texts for a number of specific types of products. There are in total six new guidance texts ; two guidelines have been updated.

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ISO 9000: Quality Systems Handbook

ISO 9000 Quality Systems Handbook (4th Edition)
By David Hoyle

Description:

Completely revised to align with ISO 9000:2000, this handbook remains the most comprehensive book available on this series of international standards. ISO 9000 Quality Systems Handbook is an essential guide to enable organizations to understand and apply ISO 9001:2000 requirements and the principles that underpin this radical revision of the family of standards. Unlike other books on the subject, each element, clause and requirement is analysed in detail with practical guidance provided for its implementation. The handbook is written for those managing existing quality systems as well as those establishing a quality system for the first time. It is written in an easy-to-follow format and style suitable for students, practitioners, discerning managers, instructors and auditors. It offers a range of solutions that are acceptable in many industries. Based on the final draft of ISO 9001:2000, it details the differences from the 1994 version and includes check lists, questionnaires, tips for implementers, process flow charts and a glossary of terms. Comprehensive and practical guide Covers over 250 requirements of the standard Includes useful checklists, flow charts, related standards, bibliography.

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ISO 9001: 2000 Quality Management System Design

ISO 9001: 2000 Quality Management System Design
By Jay Schlickman

Description:

An effective ISO 9001:2000 quality management system, driven by a fully compliant quality manual, is key in meeting ISO 9000 quality standards and a must for obtaining ISO certification. Written by an RAB-certified quality management systems lead auditor, with 40 years of industrial experience - who has a 10-year track record in the consultation and auditing support of over 100 ISO-certified organizations-this book provides the design principles and techniques for implementing an effective quality management system.

The book describes the design rules required to document, implement and demonstrate quality management system effectiveness in compliance with the latest version of the ISO 9000 International Standard. This systematic and engineering approach simplifies the many complexities in maintaining compliance with ISO standards. This hands on guide is packed with tips and insights the author has garnered form personally designing quality management systems that integrate organizational strategy with quality management. Moreover, the book helps professionals create meaningful documentation and a user friendly, informative quality manual that together form the core of an effective and responsive quality management system.

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USP NF 2007 (United States Pharmacopeia/National Formulary)

USP NF 2007 (United States Pharmacopeia/National Formulary)

Description:

The United States Pharmacopeia is a compendium of quality control tests for drugs and excipients to be introduced into a medicinal formulation. It is published every year [1] by the United States Pharmacopoeial Convention. It forms the basis of enforcement actions by the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration and is the official pharmacopoeia of the U.S.A. and many other nations. Therefore, in case of a dispute, those methods for, amongst others, identification, assay and purity determination of a drug substance or excipient which are stated in the USP will be the legally binding ones.

Within the field the compendium is referred to simply as the USP. The initials USP are affixed to materials' names to indicate that they conform to the specifications in the USP and may be used medicinally.

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Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer, 5th edition

Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer
By Sidney H. Willing

Description:

Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.

This newly revised and expanded reference examines United States law and governmental policy affecting domestic and multinational pharmaceutical manufacturing, recommending pragmatic ways to interpret and comply with FDA Current Good Manufacturing Practice (CGMP) regulation and related criteria, and focusing on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers. Fifth Edition covers cross-licensing, joint ventures, strategic alliances, mergers, acquisitions, and divestitures that emphasize the necessity of maintaining quality control!

Adds descriptions of the Malcolm Baldrige National Quality Award and the ISO 9000 that drive customer satisfaction.

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Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
By Syed Imtiaz Haider


Description:

One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls, and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to achieve compliance, or the standard operating procedures and documentation required.

This text provides the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard Operating Procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States.

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Indian Pharmacopoeia 1996

ISBN: 8190065831

Place of Publication: New Delhi

Publisher: The Controller of Publications

Edition: 1st ed.

Year of Publication: 2003

Physical Description: 140p.

Book Format: Hardcover

Language: English

Description:
The latest edition of the Indian Pharmacopoeia was published in 1996. It was updated by additions and amendments introduced through addendum 2000. Under the Drugs and Cosmetics Act, 1940, the Indian Pharmacopoeia is the legally recognised book of standards for the quality of drug substances and their preparations included therein. In view of the rapid developments is pharmaceutical sciences and technology, it became necessary to make further changes in the existing compendium. Addendum 2002 amends as well as adds new drugs and preparations to the Indian pharmacopoeia 1996 with a view to keeping the pharmacopoeia updated to the extent possible. Besides amending the existing monographs and appendices, it contains 19 new monographs including monographs of 12 antiretroviral drugs and 7 formulations of these substances. A new appendix on residual solvents has been incorporated. Some monographs have undergone major amendments. The appendix on high performance liquid chromatography has been replaced with a new version which also includes the ion chromatography. The Addendum 2002 is a companion volume to the Indian pharmacopoeia which is indispensable for all concerned with the quality of drugs.

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PART 1
PART 2
PART 3

Password: www.w5awarez.com
Serial: 1111-1111

Introduction to Renal Therapeutics

Introduction to Renal Therapeutics

By Caroline Ashley and Clare Morlidge

Publisher:Pharmaceutical Press

Pages:300 2008-01-31

ISBN:0853696888

PDF : 1.4 MB

Description:

This work gives an introduction to all aspects of drug use in renal failure.”Introduction to Renal Therapeutics” is an introduction to all aspects of drug use in renal failure. Covering various diseases affecting the kidneys, each chapter discusses the disease process and treatment. It also addresses the role of the pharmacist in patient care.
Case studies and questions and answers are included at the end of each chapter.Written by members of the UK Renal Pharmacy Group, this book will be of particular interest to anyone new to, or planning a career in, renal pharmacy. It will also be of interest to nonspecialists who deal with renal patients and to pharmacy students, and to any healthcare professional with an interest in renal medicine.

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Essentials of Clinical Research

Essentials of Clinical Research

Publisher:Springer

Language: English

ISBN: 1402084854

Pages: 360

PDF 2 Mb

Description: This book is designed to provide the “student” interested in clinical research a foundation upon which to build more advanced study. The book focuses on clinical trials, in contrast to the many excellent textbooks that address epidemiological research. With the recent interest in patient oriented research, this book should provide a knowledge base that is not necessarily covered in other texts. Chapters discussing the FDA’s role in clinical research, Data Safety and Monitoring Boards, Postmarketing studies, the use of placebo controls, and a focus on clinical trials illustrates this point. In addition, new types of clinical research are evolving, and as such, this book discusses genetic, pharmacoepidemiologic, and implementation research. Finally, chapters on tips on how to write a grant, the mentoring process, and how to present ones research results are unique to this book.

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Pharmacogenomics and Personalized Medicine

Pharmacogenomics and Personalized Medicine

By Nadine Cohen

Publisher: Humana Press

Pages: 528 2008-09-25

ISBN 1934115045 PDF 7 MB

With all the multitude of challenges facing the pharmaceutical research and development process, the industry is actively exploring the relationships between human genetics and drug responsiveness, susceptibility to disease and disease severity. In Pharmacogenomics and Personalized Medicine, leading experts from the pharmaceutical industry, the scientific community and the government provide guidance for conducting pharmacogenomic research from discovery to the market, while also presenting a realistic perspective on the challenges, practicalities and obstacles in its application. Focusing on DNA data and associated analytical methodologies, with a consideration for complementary RNA-based studies, this volume includes a wide array of vital, cutting-edge research.Comprehensive and timely, Pharmacogenomics and Personalized Medicine will assist novice and experienced investigators alike in the understanding of the current scientific challenges in applying pharmacogenomics to drug discovery and clinical development.

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ADVANCED DRUG FORMULATION DESIGN TO OPTIMIZE THERAPEUTIC OUTCOMES

ADVANCED DRUG FORMULATION DESIGN TO OPTIMIZE THERAPEUTIC OUTCOMES

By Roberr O. Williams III, David R. Taft and Jason T. McConville

Description:
Advanced Drug Formulation Design to Optimize Therapeutic Outcomes demonstrates how modern compound designs and conveying technologies crapper be utilised to meliorate take effectualness and communication outcomes in portion therapeutic categories or disease states.
This aggregation discusses nanoparticle systems for cancer treatments, and also presents selection bounds immono-regulation agents for surgery and the topical targeting of drugs, especially poorly liquid solvable drugs to wage enhanced therapeutic outcomes. In addition, it highlights areas of therapy display the most prospect for transformation in clinical outcomes via modern compound design.

Features:
*Addresses numerous modern compound and conveying technologies, including mucoadhesion, chronopharmaceutical conveying finished sharp conveying devices, targeted nanoparticle systems, and modern solubilization technologies with liposomal conveying
*Covers field therapeutic categories much as communicable disease, cancer, system disorders, and secretor disorders
*Includes pre-clinical or clinical evidence, display an enhanced therapy achieved with modern compound organisation
*Discusses difficult-to-treat tumors requiring therapy agents to transfer the murder mentality barrier, which is of portion welfare for rising the coverall effectualness of much drugs with nonindulgent side-effects when administered in broad doses.

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