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Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition
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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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Posted in books by kdsaggi on Oct. 08, 2008 // 12:09
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Sterile Product Facility Design and Project Management, Second Edition
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Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project
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Posted in books by kdsaggi on Oct. 08, 2008 // 12:11
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Calibration in the Pharmaceutical Laboratory
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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
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Posted in books by kdsaggi on Oct. 08, 2008 // 12:12
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Environmental Monitoring for Cleanrooms and Controlled Environments
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A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response to the scattered industry and ISO standards and technical reports on the subject, this title provides comprehensive information about environmental monitoring, including monitoring of viable and non-viable air, surfaces, water, alert and action levels, trending, procedures for responding to excursions, certification/requalification, and the application of new ISO standards. Because the interpretation of results is vital in controlling contamination, several chapters discuss the presentation of data, trending, and investigations, and how they are valuable in reducing risk to the product, process, and patient.
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Posted in books by kdsaggi on Oct. 08, 2008 // 12:13
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Cosmetic Formulation of Skin Care Products
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Specifically written to meet the needs of the cosmetic chemist and engineer, this reference outlines the latest technologies and issues pertinent to the development novel skin care
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Posted in books by kdsaggi on Oct. 08, 2008 // 12:14
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Handbook of Pharmaceutical Analysis by HPLC, Volume 6
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High pressure liquid chromatography frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening,
* A complete reference guide to HPLC
* Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development
* Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
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Posted in books by kdsaggi on Oct. 08, 2008 // 12:17
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Laboratory Auditing For Quality and Regulatory Compliance
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Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to
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Posted in books by kdsaggi on Oct. 08, 2008 // 12:44
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