Guide to Microbiological Control in Pharmaceuticals and Medical Devices

Guide to Microbiological Control in Pharmaceuticals and Medical Devices

Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition By Stephen P. Denyer, Rosamund M. Baird Publisher: CRC Number Of Pages: 504 Publication Date: 2006-12-26 ISBN-10 / ASIN: 0748406158 ISBN-13 / EAN: 9780748406159 Binding: Hardcover Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.

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Chemometrics Data Analysis for the Laboratory and Chemical Plant

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Chemometric techniques for quantitative analysis

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Analysis and purification methods in combinatorial chemistry

Product Description

Quality measurement, control, and improvement in combinatorial chemistry
Combinatorial chemistry has developed rapidly in the past decade, with great advances made by scientists working on analysis and purification of a large number of compounds and the analysis of polymer-bound compounds. However, formidable challenges lie ahead of today's researcher. For example, high-throughput analysis and purification technologies must be further developed to ensure combinatorial libraries are "purifiable," and "drugable." To this end, Analysis and Purification Methods in Combinatorial Chemistry describes various analytical techniques and systems for the development, validation, quality control, purification, and physicochemical testing of combinatorial libraries. A new volume in Wiley's Chemical Analysis series, this text has four parts covering:

• Various approaches to monitoring reactions on solid support and optimizing reactions for library synthesis
• High-throughput analytical methods used to analyze the quality of libraries
• High-throughput purification techniques
• Analytical methods applied in post-synthesis and post-purification stages

Drawing from the contributions of respected experts in combinatorial chemistry, this comprehensive book provides coverage of applications of Nuclear Magnetic Resonance (NMR), liquid chromatography/mass spectrometry (LC/MS), Fourier Transform Infrared (FTIR), micellar electrokinetic chromatography (MEKC) technologies, as well as other analytical techniques.
This eminently useful volume is an essential addition to the library of students and researchers studying or working in analytical chemistry, combinatorial chemistry, medicinal chemistry, organic chemistry, biotechnology, biochemistry, or biophysics.

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Product Details

• Hardcover: 466 pages
• Publisher: Wiley-Interscience; 1 edition (December 15, 2003)
• Language: English
• ISBN-10: 0471269298
• ISBN-13: 978-0471269298

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Hand book of pharmaceutical manufacturing hand book

Pharmaceutical Manufacturing Handbook: Regulations and Quality (Pharmaceutical Development Series)
By Shayne Cox Gad

Publisher: Wiley-Interscience
Number Of Pages: 856
Publication Date: 2008-03-28
ISBN-10 / ASIN: 0470259590
ISBN-13 / EAN: 9780470259597
Binding: Hardcover

Everything you need to ensure full compliance and superior quality control

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines.

The team of expert authors, all familiar with the many issues involved in compliance and quality control, offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing. The editor, who has more than thirty years’ experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Among the key topics covered are:
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Enforcement of current good manufacturing practices
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Inspections by health regulatory agencies
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Creating and managing a quality management system
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Personnel training within pharmaceutical manufacturing
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Microbiology of non-sterile pharmaceutical manufacturing
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Pharmaceutical manufacturing validation principles

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