Pharmaceutical Production Facilities

Author: Cole
Publisher: Taylor & Francis
ISBN: 9780748404384
Format: PDF, ePub, Docs
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Pharmaceutical Production Facilities: Design and Applications considers the concepts and constraints that have to be considered in the design of small, medium and large scale production plants. The layout, along with the flow of materials and personnel through facilities are considered with reference to ensuring compliance with current good manufacturing practice. The book explains how clean rooms have developed, and how recent regulations affect their design. The latest concepts for reducing contamination levels from the operator and the product are discussed. It assess current changes in standards and quality control and makes suggestions for the "ideal production environment" to enable standards to be validated to current standards.

Pharmaceutical Technology Tableting Technology

Author: James I. Wells
Publisher: CRC Press
ISBN: 9780136629580
Format: PDF, Kindle
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Dealing exclusively with compression technology, this text reflects the continued popularity of the tablet as a drug form, and thereby the need to refine and enhance the pharmaceutical industry's knowledge of compression.

Excitatory Amino Acid Receptors

Author: Povl Krogsgaard-Larsen
Publisher: Taylor & Francis
ISBN: 9780132967167
Format: PDF, ePub, Docs
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Designed to reflect the growing awareness of the chemical aspects of excitatory amino acids, this text uses computer-based methods and X-ray techniques to depict and analyze molecules and structure-activity relationships. The book incorporates stereochemical principles into all analyses.

Modern Applications of Plant Biotechnology in Pharmaceutical Sciences

Author: Saurabh Bhatia
Publisher: Academic Press
ISBN: 0128024984
Format: PDF
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Modern Applications of Plant Biotechnology in Pharmaceutical Sciences explores advanced techniques in plant biotechnology, their applications to pharmaceutical sciences, and how these methods can lead to more effective, safe, and affordable drugs. The book covers modern approaches in a practical, step-by-step manner, and includes illustrations, examples, and case studies to enhance understanding. Key topics include plant-made pharmaceuticals, classical and non-classical techniques for secondary metabolite production in plant cell culture and their relevance to pharmaceutical science, edible vaccines, novel delivery systems for plant-based products, international industry regulatory guidelines, and more. Readers will find the book to be a comprehensive and valuable resource for the study of modern plant biotechnology approaches and their pharmaceutical applications. Builds upon the basic concepts of cell and plant tissue culture and recombinant DNA technology to better illustrate the modern and potential applications of plant biotechnology to the pharmaceutical sciences Provides detailed yet practical coverage of complex techniques, such as micropropogation, gene transfer, and biosynthesis Examines critical issues of international importance and offers real-life examples and potential solutions

Good Design Practices for GMP Pharmaceutical Facilities Second Edition

Author: Terry Jacobs
Publisher: CRC Press
ISBN: 1482258919
Format: PDF, ePub, Mobi
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This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Active Pharmaceutical Ingredients

Author: Stanley Nusim
Publisher: CRC Press
ISBN: 1439803390
Format: PDF, Kindle
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To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. Topics include: Safety, efficacy, and environmental/regulatory requirements Analysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and China The FDA’s intensified foreign inspection program Multi-use and flexible design facilities The shift from maintenance scheduling to built-in reliability This second edition focuses on the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the United States and international regulatory agencies.

Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 9780470259801
Format: PDF, Docs
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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with 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.

Good Manufacturing Practices for Pharmaceuticals Sixth Edition

Author: Joseph D. Nally
Publisher: CRC Press
ISBN: 9781420020939
Format: PDF, ePub
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With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

Good Manufacturing Practices for Pharmaceuticals

Author: Sidney H. Willig
Publisher:
ISBN: 9780824797706
Format: PDF, Mobi
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Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to interpret and comply with FDA CGMP regulations while meeting the goals of a comprehensive controls system to preserve product integrity.