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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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Why has the prior edition been successful? All steps of the analytical procedure are clearly explained, starting with the choice of a suitable TLC technique and ending with data evaluation and documentation. Special emphasis is put on the proper choice of materials for TLC. Properties and functions of various materials and the TLC equipment are described, covering e. g. precoated layers, solvents and developing chambers, and including information on suppliers. Many practical hints for trouble shooting are given. All this is illustrated with numerous coloured figures.
How to use TLC in compliance with GLP/GMP regulations is described in detail, including the required documentation. Therefore the reader can very easily compile his own standard operating procedures.
Download Link: -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.
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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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
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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In the second edition of Principles I have attempted to maintain the emphasis on basics, while updating the examples to include more recent results from the literature. There is a new chapter providing an overview of extrinisic fluorophores. The discussion of timeresolved measurements has been expanded to two chapters. Quenching has also been expanded in two chapters. Energy transfer and anisotropy have each been expanded to three chapters. There is also a new chapter on fluorescence sensing. To enhance the usefulness of this book as a textbook, most chapters are followed by a set of problems. Sections which describe advanced topics are indicated as such, to allow these sections to be skipped in an introduction course. Glossaries are provided for commonly used acronyms and mathematical symbols. For those wanting additional informtion, the final appendix contains a list of recommended books which expand on various specialized topics.'
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DETAILS |
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 |
SYNOPSIS |
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. Downlaod |
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