Validation of Active Pharmaceutical Ingredients (APIS) PDF Download
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Author: William E. Hall
Publisher:
ISBN: 9781566766937
Category :
Languages : en
Pages : 158
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Book Description
Author: William E. Hall
Publisher:
ISBN: 9781566766937
Category :
Languages : en
Pages : 158
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Book Description
Author: Ira R. Berry
Publisher: CRC Press
ISBN: 9781574911190
Category : Medical
Languages : en
Pages : 618
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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.
Author: Ira R. Berry
Publisher:
ISBN: 9780367801205
Category : MEDICAL
Languages : en
Pages : 594
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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.
Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062
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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
Author: Daniel Harpaz
Publisher: Interpharm CRC
ISBN: 9781574910421
Category : Medical
Languages : en
Pages : 496
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Book Description
Fourteen contributions offer definitive guidance to both the manufacturer and the purchaser of bulk pharmaceutical chemicals on the legal, regulatory, and manufacturing process for active pharmaceutical ingredients and excipients. The text emphasizes validation, the key element of good manufacturing practice, with information from a group of industry experts on facilities, procedures, quality assurance, and other functions. Acceptable and achievable practices and regulatory requirements of the dosage form sector of the pharmaceutical industry are related to the bulk pharmaceutical chemical (BPC) producer in chapters which cover topics such as: the legal framework for the regulation of BPCs, drug master files, quality assurance systems, and vendor qualification and certification. Annotation copyrighted by Book News, Inc., Portland, OR
Author: Stanley Nusim
Publisher: CRC Press
ISBN: 1439803390
Category : Medical
Languages : en
Pages : 456
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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. 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 envi
Author: James P. Agalloco
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 760
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Book Description
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Author: Oona McPolin
Publisher: Lulu.com
ISBN: 0956152813
Category : Medical
Languages : en
Pages : 154
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Book Description
This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
Author: Stanley Nusim
Publisher: CRC Press
ISBN: 9780824702939
Category : Medical
Languages : en
Pages : 368
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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.
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1118971116
Category : Medical
Languages : en
Pages : 740
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Book Description
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
