Microbial Contamination Control in Parenteral Manufacturing

This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.


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Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition

A Practical Guide to Microbial Limit Methodologies

In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies.

Includes New and Updated Material

Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation.

Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

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The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.


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Good Design Practices for GMP Pharmaceutical Facilities

A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.


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Good Laboratory Practice Regulations Vol 69

Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation.

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British Pharmacopoeia 2009

"The British Pharmacopoeia" ("BP") 2009 is the authoritative, current collection of standards for UK medicinal substances and the official source of all UK pharmaceutical quality standards. It is an essential reference for anyone involved in pharmaceutical research, development, manufacture and testing, and plays a vital role in ensuring that all medicinal substances on the UK market meet standards of safety, quality and efficacy.The "BP" comprises monographs, which set out the mandatory standards for active substances, excipients and formulated preparations, together with supporting General Notices, Appendices (test methods, reagents, etc) and Reference Spectra. Detailed information and guidance on various aspects of current pharmacopoeial policy and practice are provided in the Supplementary Chapters of the "BP".The "BP" is supplied in a variety of formats designed for ease of use and a wide range of applications. The hard copy edition comprises a five-volume boxed set containing the "BP" in four volumes and the "BP" (Veterinary) volume, plus single user access to the "BP" Online, the dedicated BP website. The online format is easy to network, allowing access for a specified number of users or across an entire organisation site.Following registration - using the ID code supplied with the hard copy - customers will be granted a single user licence to access BP on-line and will have the option to receive the CD-ROM, which contains the whole of the current "British Pharmacopoeia".It is effective as of 1 January 2009. It includes: a significant number of new UK monographs; all "European Pharmacopoeia 6th Edition" material up to and including "Supplement 6.2" integrated into the text of "BP 2009"; new and revised monographs for Complementary, Herbal and Homoeopathic medicines with their own section in Volume III; and networking with full technical support from TSO, the publisher of the "BP". The on-line version delivers the complete text of the "British Pharmacopoeia and European Pharmacopoeia" standards to your PC. The new features include an alphabetical index, user-friendly search interface design, and a facility to create a 'My BP' section." British Pharmacopoeia 2009" eBook - "The complete British Pharmacopoeia 2009" is now available exclusively to "BP 2009" purchasers in an innovative new format. The eBook is greatly suited to this large reference text making the information contained within it available to all of those who wish to access it on the move and away from their desks.British Pharmacopoeia 2009 Concurrent Licence (Online) - "The British Pharmacopoeia" is available as a network licence which can be used on a concurrent user basis. It allows a designated number of staff simultaneous access to the online version of the "British Pharmacopoeia 2009". Once set up, your workforce can then start using the BP at their convenience.

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Dekker Encyclopedia of Nanoscience and Nanotechnology - 5 Volume Set

Placing specialists at the forefront of the nanoscience revolution, this reference identifies current challenges and development paths sure to influence fields ranging from materials and surface science, chemistry, and biomedicine to computer technology, information processing, and mechanical, optical, and electrical engineering-examining the design, application, and utilization of devices, techniques, and technologies critical to research at atomic, molecular, and macromolecular levels ranging from 1-100 nanometers.

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http://rapidshare.com/files/117703166/encyclo_nanosc_tech.part1.rar

http://rapidshare.com/files/117708177/encyclo_nanosc_tech.part2.rar