The Pharmaceutical Quality Control Handbook PDF Download
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Author: Rhys Bryant
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 232
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Book Description
Author: Rhys Bryant
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 232
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Book Description
Author: Murray Sam Cooper
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 312
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Book Description
Author: Rosamund M. Baird
Publisher: CRC Press
ISBN: 0203305191
Category : Medical
Languages : en
Pages : 274
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Book Description
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi
Author: P.B. Deasy
Publisher: Elsevier
ISBN: 1483165027
Category : Medical
Languages : en
Pages : 412
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Book Description
The Quality Control of Medicines documents the proceedings of the 35th International Congress of Pharmaceutical Sciences, organized by the Pharmaceutical Society of Ireland on behalf of the Federation Internationale Pharmaceutique, held in Dublin, on 1-5 September 1975. The theme chosen for the Congress was ""the basis for the quality control of medicines"", because of the importance and relevance of quality control in the production and distribution of medicines at national and international levels. This volume is arranged according to the manner in which the theme of the Congress was developed by the eminent invited speakers. Following the inaugural address a main symposium was held where five speakers presented a review of the quality control of medicines under the general headings of (i) chemical and physical aspects; (ii) biological aspects; (iii) control of drug delivery systems; (iv) storage problems; and (v) problems of international control. Certain aspects of the content of the main symposium were then developed in greater depth in parallel symposia. In the first parallel symposium some novel physicochemical aspects of the quality control of medicines were treated under the headings of spectrofluorimetry, mass spectrometry, detection in gas chromatography, and automation in pharmaceutical analysis. The second parallel symposium developed certain microbiological aspects of quality control under the headings of sterility testing and microbiological control of non-sterile products and ophthalmic preparations. The final symposium on submissions to regulatory bodies and international aspects of drug control covered aspects of politics in submissions, regulatory problems in small countries, and various pharmacopoeial problems.
Author: Mr. Manohar A. Potdar
Publisher: Pragati Books Pvt. Ltd.
ISBN: 9788185790596
Category : Pharmaceutical industry
Languages : en
Pages : 424
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Book Description
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857
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Book Description
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 offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Author: Walkiria S. Schlindwein
Publisher: John Wiley & Sons
ISBN: 1118895215
Category : Science
Languages : en
Pages : 368
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Book Description
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Author: Oliver Schmidt
Publisher: CRC Press
ISBN: 142002602X
Category : Medical
Languages : en
Pages : 392
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Book Description
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr
Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 143985016X
Category : Medical
Languages : en
Pages : 484
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Book Description
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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Book Description
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
