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, 5th edition

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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Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT

Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners.

Topics covered include:

• Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions.
• Post-approval considerations and regulatory filing strategies to support a global supply chain.
• Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications.
• Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products.
• Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT).
• USP-NF testing in support of stability.
• Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing.
• Discussion of matrixing and bracketing to support reduced stability testing.
• Overview of stability programs for biologics and drug-in-devices pharmaceutical products.

This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.

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cGMP: Generators, Effectors and Therapeutic Implications

cGMP: Generators, Effectors and Therapeutic Implications

After the discovery of endogenous NO formation in the late '80s and the 1998 Nobel Prize in Physiology or Medicine, many researchers and physicians again became interested in the NO/sGC interaction and cGMP-dependent signaling. This book is an enthusiastic celebration of cyclic guanosine monophosphate (cGMP) and amply illustrates the importance of this field of science to patients and the way in which the field has evolved. It is exclusively devoted to this exciting and important signaling molecule, addressing all recent advances in understanding guanylate cyclase regulation, NO/sGC interactions, cGMP effector mechanisms and their pathophysiological and pharmacological implications. Particular attention will also be given to clinical applications of the novel cGMP-elevating drugs which are on the horizon, thus spanning the continuum from basic science to clinic.

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Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

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User Friendly Guide to Multivariate Calibration and Classification

User Friendly Guide to Multivariate Calibration and Classification

The field of chemometrics in general and multivariate calibration and classification in particular is now an essential tool for many analytical techniques. This book provides a readable text, for non-mathematicians, as a introduction to these areas for people with little or moderate knowledge of chemometrics. The book has been designed in an atractive and easily read format, with many diagrams and the use of margin notes to highlight important features.

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Instrumentation and Control Systems Documentation

Instrumentation and Control Systems Documentation

This book provides the reader with knowledge needed to understand and apply the symbols and documents used to define a modern industrial instrumentation and control system. The documents that describe modern industrial processes, like most technical work, assume some level of understanding on the reader’s part. The documents use aschematic, symbol-based “language” that may resemble Mayan hieroglyphics to those unfamiliar with the process nomenclature. The symbols, however, include a wealth of information once you are able to translate them.

This book will train you to read, understand, and apply the symbols and documents used to define a modern industrial instrumentation and control system. For more experienced professionals, insights into using the symbols and documents more effectively are provided. Variations in the use of symbols and documents are given as well as the pitfalls to avoid.

To better understand process documentation today, insight into how and when documents are developed, who develops them, why they are developed, and how they are used is provided. The types of documents discussed include process flow diagrams, piping and instrumentation drawings, instrument lists, specification forms, logic diagrams, installation details, location plans, and loop diagrams.

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Calibration in the Pharmaceutical Laboratory

Calibration in the Pharmaceutical Laboratory

Increasingly, pharmaceutical scientists must not only be specialists in their field but must also be familiar with legislation that governs the use of equipment in their industry. The regulation of test and measuring equipment changes continually as new regulations are introduced and new equipment is developed. Calibration in the Pharmaceutical Laboratory provides general background on laboratory balances and precision scales, insight into mass measurements and associated errors, and detailed information on key quality issues associated with weighing. Managers responsible for QC and QA will find this book an invaluable toolwhen setting out SOPs for balances and scales used throughout the manufacturing and testing process.

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Validation in Chemical Measurement

Validation in Chemical Measurement

The validation of analytical methods is based on the characterisation of a measurement procedure (selectivity, sensitivity, repeatability, reproducibility). This volume collects 31 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance". They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of validation into the standard procedures of every analytical laboratory. In addition, this anthology considers the benefits to both: the analytical laboratory and the user of the measurement results.

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Encyclopedia of Controlled Drug Delivery, 2 Volume Set

Encyclopedia of Controlled Drug Delivery, 2 Volume Set

Covers all aspects of controlled drug delivery, including human, agricultural and animal applications. The 70 entries, written by an international team of renowned experts, offers A-to-Z coverage of controlled drug delivery systems for researchers in the pharmaceutical and biotechnology industries, agriculture companies, medical device companies, clinical research organizations and medical schools.

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Biopharmaceutics Applications in Drug Development

Biopharmaceutics Applications in Drug Development

In the last two decades, the discipline of biopharmaceutics has undergone considerable advances, particularly with regard to bioavailability and bioequivalence as they relate to product quality and regulatory standards of approval. Textbooks in the field have not been able to keep up with the growth of current and emerging applications of regulatory aspects of biopharmaceutics.

Biopharmaceutics Applications in Drug Development fills this gap. This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.

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Molecular Biology and Biotechnology

Molecular Biology and Biotechnology

As a textbook, Molecular Biology and Biotechnology has always been immensely popular. Now in its fourth edition, it has been completely revised and updated to provide a comprehensive overview of the area, and to reflect all the latest developments. Written by recognised experts, each of the nineteen chapters describes a specific subject area relevant to the subject of biotechnology. The impressive breadth of coverage takes into account both molecular biology and industrial applications and aims to identify the impact that molecular biology has had on the development of biotechnology. Presenting information in an easily assimilated form, Molecular Biology and Biotechnology makes an ideal undergraduate text. It will be of particular interest to students of biology and chemistry, as well as to scientists from outside the field requiring a rapid introduction to the subject.

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Pharmaceutical Design And Development: A Molecular Biology Approach

Pharmaceutical Design And Development: A Molecular Biology Approach

This volume aims to introduce researchers in pharmaceutical and allied industries to the concepts and latest developments in the application of biotechnology recombinant DNA and monoclonal antibodies to drug development. The author puts biotechnology in perspective, introducing the basic concepts of cell and molecular biology and discussing both the application of protein drugs and the design of new molecular entities. The study examines the use of proteins and assay systems produced via biotechnology to the development of small-molecule drugs. A discussion of gene and somatic cell therapies is included, along with developments in diagnostic methods resulting from biotechnology. The text concludes by examining future prospects and likely developments in the field.

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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,

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

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.

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Drug Absorption Studies: In Situ, In Vitro and In Silico Models

Drug Absorption Studies: In Situ, In Vitro and In Silico Models

In the last 15 years, a great number of cell- or tissue-based in vitromodels have been introduced into the biopharmaceutics arena. These models mimic the different biological barriers that a drug has to overcome to finally reach its target organ/cell/receptor. These in vitro models have been found very useful in not only characterising the permeability behaviour of drugs molecules in epithelial and endothelial tissues, but also studying drug delivery systems for improved delivery and enhanced absorption. Compared to the complex in vivo situation, in vitro models offer a fast, convenient approach with cost advantages most of times. Most importantly, they can be standardised and automatised to be applicable to the high-throughput screening.

Starting at the molecular level of studies, continuing with cell monolayer models (both primary and cell lines) and in situ techniques as a final testing format, the book provides a practical approach to contemporary in vitro techniques for drug absorption studies. In addition, chapters on high-throughput assays, in vitro-in vivo correlation, bioinformatics and regulatory issues are covered, giving a comprehensive overview of available models and techniques. Moreover, an appendix comprised with a number of practical protocols is available online, updated as needed, should prove very helpful to apply the techniques directly to the benchside.

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Technology Transfer in Biotechnology: From Lab to Industry to Production

Technology Transfer in Biotechnology: From Lab to Industry to Production

Several new methods besides the usual organic solvent extraction have been developed over the last few years for the extraction of primary and secondary metabolites. These are: alcohol extraction with various biocompatible solvents, recovery of carboxylic acids and antibiotics with reactive extraction, dissociation extraction, aqueous two-phase extraction, and supercritical and near critical fluid extraction.Extraction and re-extraction processes are integrated into a single step by emulsion liquid membrane and solid supported liquid membrane extractions. These extraction processes are discussed and compared in this review, along with extraction with reversed micelles, and reactive extraction with the formation of a third phase at the organic-aqueous interface.

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Maintaining Cultures for Biotechnology and Industry

Maintaining Cultures for Biotechnology and Industry

To retain their usefulness, cultures that manufacture economically valuable products must be uncontaminated, viable, and genetically stable. Maintaining Cultures for Biotechnology and Industry gives practical advice necessary to preserve and maintain cells and microorganisms important to the biotechnology and pharmaceutical industries in ways that ensure they will continue to be able to synthesize those valuable metabolites. This book covers not just those strains currently being used but also those yet to be discovered and engineered.This text is essential for anyone working with cultures who wants to avoid the frustration of losing strains and needs to be able to devise and evaluate new strategies for preservation.
Key Features
* Written by hands-on experts in their respective fields
*Contains helpful tables and protocols for preserving or maintaining cells, cultures and viruses
*Discusses means to preserve cells by freezing, lyophilization, drying, cyoprotection, spore storage, continuous propagation and subculturing when absolutely necessary, and others
*Gives information needed to test cultures for stable retention of important characteristics
*Gives principles needed to devise and evaluate preservation strategies for newly identified and newly engineered cells and organisms
*Lists culture sources for each class of organism
*Includes information for characterizing and monitoring recombinant organisms, especially important because of their propensity for genetic stability
*Discusses the history of the continually evolving field of culture preservation
*Examines the importance of genetically stable cultures as it relates to maintaining patent positions.

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Flavours and Fragrances: Chemistry, Bioprocessing and Sustainability

Flavours and Fragrances: Chemistry, Bioprocessing and Sustainability

This book is an introduction to the fascinating world of aroma chemicals, essential oils, fragrances and flavour compositions for the food, cosmetics and pharmaceutical industry. The present state-of-the-art technology, the future use of resources and biotechnological approaches for the production of the respective chemical compounds are described. A large section is devoted to the description of the renewable resources of flavours: spice plants, fruits from moderate to tropical climates, vegetables, fermented and heated plants. Analytical methods, such as gas chromatography coupled to human or electronic noses or to a mass spectrometer, are outlined and consumer trends, legal and safety aspects are described. Novel renewable resources come from biotechnology. Enzymes, for example, bio-transform cheap substrates to produce flavours de novo; plant cells in culture may serve as a rich resource of genes coding for metabolic activities in transgenic producers. The book will be of great interest to scientists and engineers in the food, flavour, fragrance and pharmaceutical industries and all respective researchers in academia.

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Pharmaceutical Biotechnology

Pharmaceutical Biotechnology

The textbook on Pharmaceutical Biotechnology provides comprehensively the fundamental concepts and principles in Biotechnology to expatiate and substantiate its numerous modern applications with regard to the spectacular development in the Pharmaceutical Industry. In a broader perspective, the students studying Biotechnology at undergraduate and postgraduate levels shall be grossly benefited by its well-planned systematically developed, structured, illustrated, expanded, elaborated, and profusely exemplified subject matter.It essentially comprise five major chapters, namely: Immunology and Immunological Preparations; Genetic Recombination; Antibiotics; Microbial Transformations; and Enzyme Immobilization. Besides, there are five auxiliary chapters, namely, Advent of Biotechnology; Biosensor Technology; Bioinformatics and Data Mining; Regulatory Issues in Biotechnology; and Safety in Biotechnology, which have been specifically included so as to stimulate the students, interest and broaden their horizon of knowledge and wisdom.The authors earnestly believe that the wide coverage of various topics mentioned above would certainly render Pharmaceutical Biotechnology to serve as an exclusive source of information`s, ideas, inspirations towards research, and finding newer possible practical solutions to problems encountered in the ever green pasture using knowledge of Biotechnology in the Pharmaceutical Industry. Contents Immunology and Immunological Preparations
Genetic Recombination
Microbial Transformations
Enzyme Immobilization
Advent of Biotechnology
Biosensor Technology
Bioinformatics and Data Mining
Regulatory Issues in Biotechnology
Safety in Biotechnology

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Modern Industrial Microbiology and Biotechnology

Modern Industrial Microbiology and Biotechnology

This book is directed towards undergraduates and beginning graduate students in microbiology, food science and chemical engineering. Those studying pharmacy, biochemistry and general biology will find it of interest. The section on waste disposal will be of interest to civil engineering and public health students and practitioners. For the benefit of those students who may be unfamiliar with the basic biological assumptions underlying industrial microbiology, such as students of chemical and civil engineering, elements of biology and microbiology are introduced. The new elements which have necessitated the shift in paradigm in industrial microbiology such as bioinformatics, genomics, proteomics, site-directed mutation, metabolic engineering, the human genome project and others are also introduced and their relevance to industrial microbiology and biotechnology indicated. As many references as space will permit are included. The various applications of industrial microbiology are covered broadly, and the chapters are grouped to reflect these applications. The emphasis throughout, however, is on the physiological, biochemical principles, and where possible, the genomic principles behind these applications.

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Business Development for the Biotechnology and Pharmaceutical Industry

Business Development for the Biotechnology and Pharmaceutical Industry

Business Development in the Biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development andmarketing, locally or across the globe. Asset sales, mergers and corporate take-overs are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of productsfrom the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects.The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world.

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Reliable Design of Medical Devices, Second Edition

Reliable Design of Medical Devices, Second Edition

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

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Oral Delivery of Macromolecular Drugs: Barriers, Strategies and Future Trends

Oral Delivery of Macromolecular Drugs: Barriers, Strategies and Future Trends

Recent and rapid progress in the field of biotechnology has resulted in an increasing number of novel macromolecular drugs with great promise for further advanced research and clinical application. However, the delivery of these macromolecular drugs by routes other than the parenteral route is difficult. The pipeline of macromolecular drugs derived from biotechnology presents a challenging opportunity to develop practical dosage forms that could be dosed via the oral route. Given this, the successful oral delivery of macromolecular drugs presents an enormous opportunity. Oral Delivery of Macromolecular Drugs will provide an overview of the innovative oral delivery technologies that have demonstrated success in human testing and will go on to cite the challenges, strategies, and future trends that are to be expected.

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Biopharmaceutics and Pharmaceutical Calculations Tutorials - Australian Pharmacy Examining Council

Biopharmaceutics and Pharmaceutical Calculations Tutorials - Australian Pharmacy Examining Council

Two computer based educational modules were developed using the authoring package ToolBook Multimedia CBT Edition (Asymetrix Corporation), operating on a Windows® platform, and distributed on disk. They included tuition and assessment in the areas of pharmaceutical calculations (M1) and biopharmaceutics (M2) and were aimed at assisting overseas qualified pharmacists preparing for an Australian registration exam. Presented are the results of evaluations for the assessment programs' level of achievement of set educational objectives, frequency and patterns of use. Respondents (n=32) rated'high-very high' the extent to which the following objectives were met: encouragement of testing of tutorial knowledge (M1: 90.3%; M2: 90.0%); provision of practice using the examination question format (M1: 90.0%; M2: 96.5%); encouragement of review of tutorials based on test performance (M1: 83.9%; M2: 86.7%). The analysis of data disks (n=58) on assessment program use indicated: total tests: (M1: 1,713; M2: 1,152); questions attempted: (M1: 20,900; M2: 15,921); timer option used: this was selected in 36.9% of total tests; period of testing with timer (118.4h) and without timer (598.1h) (maximum allowable question time recorded). Overall, the assessment programs were found very valuable components of each module. They were perceived to have met their set objectives and were significantly used.

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Biopharmaceutical Process Validation

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk ofadverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.

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Developing Solid Oral Dosage Forms: Pharmaceutical Theory&Practice

This book is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with:

Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms

Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies

New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development

The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards

It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter

A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies.

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Development of Biopharmaceutical Parenteral Dosage Forms

This up-to-the-minute reference delineates;in a systematic fashion;the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products;covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemicalproperties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

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Encyclopedia of Biopharmaceutical Statistics, Second Edition

Millennium Pharmaceuticals, Cambridge, MA. Resource offers more than 3,300 lists expanded to reflect amendments to regulatory requirements and recently developed statistical methods impacting the drug review/approval process and biopharmaceutical research and development. Offers more than 3,000 equations, tables, and figures. Previous edition not cited.

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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

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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