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Validation of Active Pharmaceutical Ingredients, Second Edition

Author : Ira R. Berry

Publisher : CRC Press

Page : 618 pages

File Size : 48,26 MB

Release : 2001-12-31

Category : Medical

ISBN : 9781574911190

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Book Description

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.



Validation of Active Pharmaceutical Ingredients

Author : Ira R. Berry

Publisher :

Page : 594 pages

File Size : 11,54 MB

Release : 2001

Category : MEDICAL

ISBN : 9780367801205

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Book Description

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.



Active Pharmaceutical Ingredients

Author : Stanley Nusim

Publisher : CRC Press

Page : 452 pages

File Size : 41,91 MB

Release : 2016-04-19

Category : Medical

ISBN : 1439803390

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Book Description

To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. This book is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. This secoond edition brings readers up-to-date with 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 US and international regulatory industries.



Active Pharmaceutical Ingredients

Author : Stanley Nusim

Publisher : CRC Press

Page : 368 pages

File Size : 16,72 MB

Release : 2005-05-25

Category : Medical

ISBN : 9780824702939

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Book Description

Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety.





Introduction to Pharmaceutical Analytical Chemistry

Author : Stig Pedersen-Bjergaard

Publisher : John Wiley & Sons

Page : 752 pages

File Size : 18,42 MB

Release : 2019-02-11

Category : Science

ISBN : 111936275X

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Book Description

The definitive textbook on the chemical analysis of pharmaceutical drugs – fully revised and updated Introduction to Pharmaceutical Analytical Chemistry enables students to gain fundamental knowledge of the vital concepts, techniques and applications of the chemical analysis of pharmaceutical ingredients, final pharmaceutical products and drug substances in biological fluids. A unique emphasis on pharmaceutical laboratory practices, such as sample preparation and separation techniques, provides an efficient and practical educational framework for undergraduate studies in areas such as pharmaceutical sciences, analytical chemistry and forensic analysis. Suitable for foundational courses, this essential undergraduate text introduces the common analytical methods used in quantitative and qualitative chemical analysis of pharmaceuticals. This extensively revised second edition includes a new chapter on chemical analysis of biopharmaceuticals, which includes discussions on identification, purity testing and assay of peptide and protein-based formulations. Also new to this edition are improved colour illustrations and tables, a streamlined chapter structure and text revised for increased clarity and comprehension. Introduces the fundamental concepts of pharmaceutical analytical chemistry and statistics Presents a systematic investigation of pharmaceutical applications absent from other textbooks on the subject Examines various analytical techniques commonly used in pharmaceutical laboratories Provides practice problems, up-to-date practical examples and detailed illustrations Includes updated content aligned with the current European and United States Pharmacopeia regulations and guidelines Covering the analytical techniques and concepts necessary for pharmaceutical analytical chemistry, Introduction to Pharmaceutical Analytical Chemistry is ideally suited for students of chemical and pharmaceutical sciences as well as analytical chemists transitioning into the field of pharmaceutical analytical chemistry.



Handbook of Bioequivalence Testing, Second Edition

Author : Sarfaraz K. Niazi

Publisher : CRC Press

Page : 1012 pages

File Size : 26,84 MB

Release : 2014-10-29

Category : Medical

ISBN : 1482226375

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Book Description

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.



Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Author : James Agalloco

Publisher : CRC Press

Page : 1062 pages

File Size : 23,54 MB

Release : 2021-10-28

Category : Medical

ISBN : 1000436012

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Book Description

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture



Microbial Limit and Bioburden Tests

Author : Lucia Clontz

Publisher : CRC Press

Page : 344 pages

File Size : 25,64 MB

Release : 2008-10-14

Category : Medical

ISBN : 1420053493

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Book Description

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 c



Developments in Surface Contamination and Cleaning, Volume 7

Author : Rajiv Kohli

Publisher : William Andrew

Page : 207 pages

File Size : 27,45 MB

Release : 2014-11-18

Category : Technology & Engineering

ISBN : 0323311458

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Book Description

As device sizes in the semiconductor industries are shrinking, they become more vulnerable to smaller contaminant particles, and most conventional cleaning techniques employed in the industry are not as effective at smaller scales. The book series Developments in Surface Contamination and Cleaning as a whole provides an excellent source of information on these alternative cleaning techniques as well as methods for characterization and validation of surface contamination. Each volume has a particular topical focus, covering the key techniques and recent developments in the area. The chapters in this Volume address the sources of surface contaminants and various methods for their collection and characterization, as well as methods for cleanliness validation. Regulatory aspects of cleaning are also covered. The collection of topics in this book is unique and complements other volumes in this series. Edited by the leading experts in small-scale particle surface contamination, cleaning and cleaning control, these books will be an invaluable reference for researchers and engineers in R&D, manufacturing, quality control and procurement specification situated in a multitude of industries such as: aerospace, automotive, biomedical, defense, energy, manufacturing, microelectronics, optics and xerography. Provides a state-of-the-art survey and best-practice guidance for scientists and engineers engaged in surface cleaning or handling the consequences of surface contamination Addresses the continuing trends of shrinking device size and contamination vulnerability in a range of industries, spearheaded by the semiconductor industry and others Includes new regulatory aspects