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  1. [31]
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    تاريخ التسجيل: Nov 2008
    المشاركات: 146
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    Good Manufacturing Practices and Inspection
    • Publisher: World Health Organization

    • Number Of Pages: 413
    • Publication Date: 2007-06-06
    • ISBN-10 / ASIN: 9241547081
    • ISBN-13 / EAN: 9789241547086
    • Binding: Paperback
    Product Description:

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

    http://rapidshare.com/files/82928562/9789241547086_eng.pdf
    http://rapidshare.com/files/83128479/GMP_Inspect_QA_Pharma.zip

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    تاريخ التسجيل: Nov 2008
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    Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical 2001-12
    • Publisher: CRC
    • Number Of Pages: 496
    • Publication Date: 2001-12-27
    • ISBN-10 / ASIN: 1574443313
    • ISBN-13 / EAN: 9781574443318
    • Binding: Hardcover

    Product Description:

    A comprehensive when-and-how-to-do-it guide, this book and CD-ROM combination provides administrative solutions for achieving compliance with key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation. The text shows readers how to establish test functions and acceptance criteria in compliance with FDA perspectives. The CD-ROM contains 74 template validation standard operating procedures that users can edit and print, customizing the program to their needs. The book and CD work together to minimize the number of forms used and to ensure that the all the correct forms are used, thus avoiding the stress that usually accompanies an FDA audit.

    http://rapidshare.com/files/41853767/vsop.zip

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  3. [33]
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    تاريخ التسجيل: Nov 2008
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    GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition
    • Publisher: CRC

    • Number Of Pages: 452
    • Publication Date: 2004-04-15
    • ISBN-10 / ASIN: 0849318475
    • ISBN-13 / EAN: 9780849318474
    • Binding: Paperback

    Product Description:

    Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I. The book is presented in an convenient, easy-to-read format, organized to provide fast access to the guidelines and regulations of interest.

    http://rapidshare.com/files/145229041/GMqweedeee3ddzz0849318475.zip

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    تاريخ التسجيل: Nov 2008
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    Clarke's Analysis of Drugs and Poisons, 3rd Edition, 2004-02
    • Publisher: Pharmaceutical Press

    • Number Of Pages: 2101
    • Publication Date: 2004-02-29
    • ISBN-10 / ASIN: 0853694737
    • ISBN-13 / EAN: 9780853694731
    • Binding: Hardcover

    Product Description:

    This practical manual and standard reference work provides an authoritative source of analytical data for drugs and poisons. It is intended for use primarily by scientists faced with identifying and quantifying these substances in body fluids, tissue samples and pharmaceutical and industrial products. This completely revised and updated new edition now comprises two volumes housed in a handy slipcase. Clarke's Analysis of Drugs and Poisons is an essential requirement for all forensic and crime laboratories, toxicologists, clinical pharmacology departments, poison information centres, pathologists, clinical toxicologists, hospital pharmacists and analytical chemists. Clarke's Analysis of Drugs and Poisons was previously published as Clarke's Analysis and Identification of Drugs.

    http://rapidshare.com/files/7182798/CADP.rar.html
    http://rapidshare.com/files/146768333/tclark_ana_drg_pois3ed.zip

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    تاريخ التسجيل: Nov 2008
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    Guidelines for Safe Handling of Powders and Bulk Solids
    • Publisher: Wiley-AIChE
    • Number Of Pages: 796
    • Publication Date: 2004-11-15
    • ISBN-10 / ASIN: 0816909512
    • ISBN-13 / EAN: 9780816909513
    • Binding: Hardcover.

    Product Description:

    Powders and bulk solids, handled widely in the chemical, pharmaceutical, agriculture, smelting, and other industries present unique fire, explosion, and toxicity hazards. Indeed, substances which are practically inert in consolidated form may become quite hazardous when converted to powders and granules. The U.S. Chemical Safety and Hazard Investigation Board is currently investigating dust explosions that occured in 2003 at WestPharma, CTA Acoustics, and Hayes-Lemmerz, and is likely to recommend that companies that handle powders or whose operations produce dust pay more attention to understanding the hazards that may exist at their facility. This new CCPS guidelines book will discuss the types of hazards that can occur in a wide range of process equipment and with a wide range of substances, and will present measures to address these hazards.
    http://rapidshare.com/files/78078515/Guidelines_Safe_Handling_Powders.rar

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    Pharmaceutical Guidelines (Every Pharma Industry Must Have)
    PIC
    USFDA
    WHO
    GMP-Drug substances:
    ICH
    PIC
    USFDA
    WHO
    ICH Guidelines:
    Efficacy
    Multidisciplinary
    Quality
    Safety
    Regulatory Audits:
    PIC
    WHO

    http://rapidshare.com/files/67568085/GMP_and_Regulatory_Guidelines.rar

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    تاريخ التسجيل: Nov 2008
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    Polymorphism: in the Pharmaceutical Industry
    • Publisher: Wiley-VCH
    • Number Of Pages: 433
    • Publication Date: 2006-04-17
    • ISBN-10 / ASIN: 3527311467
    • ISBN-13 / EAN: 9783527311460
    • Binding: Hardcover
    Book Description:

    Edited by one of the leading experts in the field, this handbook emphasizes why solid-state issues are important, which approaches should be taken to avoid problems and exploit the opportunities offered by solid state properties in the pharmaceutical and agricultural industries.
    With its practical approach, this is at once a guideline for development chemists just entering the field as well as a high-quality source of reference material for specialists in the pharmaceutical and chemical industry, structural chemists, physicochemists, crystallographers, inorganic chemists, and patent departments.
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    http://rapidshare.com/files/94365103/New_Folder__2_.rar

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    Polymorphism in Pharmaceutical Solid
    • Publisher: Informa HealthCare
    • Number Of Pages: 448
    • Publication Date: 1999-03-03
    • ISBN-10 / ASIN: 0824702379
    • ISBN-13 / EAN: 9780824702373
    • Binding: Hardcover

    Product Description:

    "Presents a comprehensive examination of polymorphic behavior in pharmaceutical development-demonstrating with clear, practical examples how to navigate complicated crystal structures. Edited by the recipient of the American Association of Pharmaceutical Scientists' 1998 Research Achievement Award in Analysis and Pharmaceutical Quality."
    http://rapidshare.com/files/12436523/pphs.rar.html

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    تاريخ التسجيل: Nov 2008
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    Pharmaceutical Pre-Approval Inspections
    • Publisher: Informa HealthCare
    • Number Of Pages: 304
    • Publication Date: 2008-03-05
    • ISBN-10 / ASIN: 0849391849
    • ISBN-13 / EAN: 9780849391842
    • Binding: Hardcover

    Product Description:
    This Second Edition is an essential guide to preparing for FDA pre-approval inspections—taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.

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    http://rapidshare.com/files/137270053/0849391849.rar
    http://rapidshare.com/files/137661886/tpharma_preappr_inspect2ed.zip

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    تاريخ التسجيل: Nov 2008
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    Pharmaceutical Project Management
    • Publisher: Informa HealthCare
    • Number Of Pages: 280
    • Publication Date: 2008-03-17
    • ISBN-10 / ASIN: 0849340241
    • ISBN-13 / EAN: 9780849340246
    • Binding: Hardcover

    Product Description:

    Encompassing the full spectrum of project management’s role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through manufacturing and launch.
    DOWNLOAD LINK:


    http://rapidshare.com/files/135443232/tpharmap_projmgmt2ed.zip

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