Batch Processes

Reduced time to market, lower production costs, and improved flexibility are critical success factors for batch processes. Their ability to handle variations in feedstock and product specifications has made them key to the operation of multipurpose facilities, and therefore quite popular in the specialty chemical, pharmaceutical, agricultural, and biotechnology-enabled products industries. The editors of Batch Processes analyze the design, development, operations, and control of batch processes - providing answers to the most challenging and pressing problems associated with their use. They present a reference unique in its coverage of both process design and operations management issues. Leading experts from industry and academia contribute chapters that discuss batch process scheduling, design software tools, and the latest technologies, their implementation, and their respective advantages. The book is presented in four parts for easy reference. Part I, Batch Processing General Overview, introduces the topic and discusses batch processing industries. Part II, Batch Processing Design Issues, includes information on conceptual design and synthesis, reactors in bioindustries, distillation, crystallization, and pollution prevention. Part III, Batch Processing Management, informs the reader on modeling and optimization, planning and scheduling, monitoring and control, and supply chain management. Part IV, Future of Batch Processing, offers concluding remarks and contemplates the future of batch processing.

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In Silico Technologies in Drug Target Identification and Validation

The pharmaceutical industry relies on numerous well-designed experiments involving high-throughput techniques and in silico approaches to analyze potential drug targets. These in silico methods are often predictive, yielding faster and less expensive analyses than traditional in vivo or in vitro procedures. In Silico Technologies in Drug Target Identification and Validation addresses the challenge of testing a growing number of new potential targets and reviews currently available in silico approaches for identifying and validating these targets. The book emphasizes computational tools, public and commercial databases, mathematical methods, and software for interpreting complex experimental data. The book describes how these tools are used to visualize a target structure, identify binding sites, and predict behavior. World-renowned researchers cover many topics not typically found in most informatics books, including functional annotation, siRNA design, pathways, text mining, ontologies, systems biology, database management, data pipelining, and pharmacogenomics. Covering issues that range from prescreening target selection to genetic modeling and valuable data integration, In Silico Technologies in Drug Target Identification and Validation is a self-contained and practical guide to the various computational tools that can accelerate the identification and validation stages of drug target discovery and determine the biological functionality of potential targets more effectively.

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http://rapidshare.com/files/48860200/Silico_tech_drug_target_identif_validation.rar

Good Laboratory Practice Regulations, Fourth Edition

Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments.

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http://rapidshare.com/files/47846820/GLP_Regulations_4th.zip

Facility Validation: Theory, Practice, and Tools

Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provides definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices (GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions, and terminology associated with GMPs and details the philosophy and key principles of validation. He demonstrates how to set up an infrastructure for implementing a validation program. Included in the book are practical examples of validation documents and SOPs, a comprehensive glossary of validation terminology, and coverage of best practices for evaluating validation programs.

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http://rapidshare.com/files/47443195/Facility_Validation.zip

Rules and Guidance for Pharmaceutical Manufacturers and Distributors

Rules and Guidance for Pharmaceutical Manufacturers and Distributors

Publisher:Pharmaceutical Press; Rev Ed edition( 27 April 2007) | ISBN-10: 0853697191 | PDF | 9.3 Mb | 430 pages

Since the 2002 edition of 'Rules and Guidance for Pharmaceutical Manufacturers and Distributors', commonly known as the 'Orange Guide', there have been many changes and additions to the detailed European Community guidelines on Good Manufacturing Practice (GMP). In addition, there is a new Directive dealing specifically with GMP and the Community Code relating to medicinal products for human use (Council Directive 2001/83/EC) has itself been the subject of substantial revision, via amending Directive 2004/27/EC, and these changes have been transposed into UK domestic legislation.

From its first publication in 1971 the 'Orange Guide', has been an essential reference for all involved in the manufacture and distribution of medicines in Europe.

The 'Orange Guide' collates in one convenient and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. Compliance with Good Manufacturing Practice and Good Distribution Practice requirements is essential in the production and distribution of medicines for human use to safeguard public health and to comply with legislation.

It is of particular relevance to all holders of Manufacturer’s Licences and Wholesale Dealer’s licences and to their Qualified Persons and Responsible Persons, who have a responsibility for ensuring compliance with many of these regulatory requirements.

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Gas Chromatography and Mass Spectrometry

This guide provides, under one cover, a wealth of practical information designed to facilitate the effectiveness of the GC/MS user. Separation conditions for numerous compound types are provided along with derivatized and underivatized compounds. A section on how to interpret mass spectral data, an extensive correlation of ion masses and neutral losses with possible structures, and examples of mass spectra are provided to further aid structure determination. Also included are basic information on instrumentation, ionization methods, quantitation, tips on the operation of mass spectrometers, the best derivatization procedures for a variety of compound types, troubleshooting techniques, and a variety of other information found to be useful to the practicing user of GC/MS instrumentation. This guide would be immediately valuable to the novice as well as the experienced GC/MS user who may not have the breadth of experience covered in this book.

Key Features:
* Condenses and organizes recent and essential information for new and experienced GC/MS users
* Comprehensively indexed and referenced
* Includes practical methods of analysis
* Serves as a text reference for short practical courses on the subject

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http://rapidshare.com/files/47056420/GC_MS.zip

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

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 - I : http://rapidshare.com/files/46920750/International_Biotechnology_and_Pharmaceutical_GMPS.part1.rar

PART - II: http://rapidshare.com/files/47045149/International_Biotechnology_and_Pharmaceutical_GMPS.part2.rar