Author: Daniel Harpaz
Publisher: Interpharm CRC
ISBN: 9781574910421
Category : Medical
Languages : en
Pages : 496
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
Validation of Bulk Pharmaceutical Chemicals
Author: Daniel Harpaz
Publisher: Interpharm CRC
ISBN: 9781574910421
Category : Medical
Languages : en
Pages : 496
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
Publisher: Interpharm CRC
ISBN: 9781574910421
Category : Medical
Languages : en
Pages : 496
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
Validation of Pharmaceutical Processes
Author: James P. Agalloco
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 762
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
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 762
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
Handbook of Validation in Pharmaceutical Processes, Fourth Edition
Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062
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
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062
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
Validation of Active Pharmaceutical Ingredients, Second Edition
Author: Ira R. Berry
Publisher: CRC Press
ISBN: 9781574911190
Category : Medical
Languages : en
Pages : 618
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.
Publisher: CRC Press
ISBN: 9781574911190
Category : Medical
Languages : en
Pages : 618
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.
Pharmaceutical Calibration, Validation and Qualification: A Comprehensive Approach
Author: Shiv Shankar Shukla
Publisher: Springer Nature
ISBN: 9811990026
Category : Medical
Languages : en
Pages : 216
Book Description
This up-to-date and unique monograph covers the different aspects of pharmaceutical validation, calibration, qualification and documentation. It discusses the various methods and processes under all these heads. It includes eight major sections and exhaustively covers each topic.The book includes interesting and timely topics like the ‘Validation of herbals’ considering the increasing reliance on herbal medicines. It includes a section of validation of dosage forms, which is an essential topic for any pharmaceutical scientist. The chapters provide lucid illustrations, figures, flowcharts and other diagrams to facilitate understanding. A final section on 'expert opinion' provides a rundown about the global scenario to the readers. The book serves as a complete reference material for students, researchers and industry experts in the field of pharmaceutical sciences, medicinal chemistry and pharmacology.
Publisher: Springer Nature
ISBN: 9811990026
Category : Medical
Languages : en
Pages : 216
Book Description
This up-to-date and unique monograph covers the different aspects of pharmaceutical validation, calibration, qualification and documentation. It discusses the various methods and processes under all these heads. It includes eight major sections and exhaustively covers each topic.The book includes interesting and timely topics like the ‘Validation of herbals’ considering the increasing reliance on herbal medicines. It includes a section of validation of dosage forms, which is an essential topic for any pharmaceutical scientist. The chapters provide lucid illustrations, figures, flowcharts and other diagrams to facilitate understanding. A final section on 'expert opinion' provides a rundown about the global scenario to the readers. The book serves as a complete reference material for students, researchers and industry experts in the field of pharmaceutical sciences, medicinal chemistry and pharmacology.
Validation of Active Pharmaceutical Ingredients
Author: Ira R. Berry
Publisher:
ISBN: 9780367801205
Category : MEDICAL
Languages : en
Pages : 594
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.
Publisher:
ISBN: 9780367801205
Category : MEDICAL
Languages : en
Pages : 594
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 Aseptic Pharmaceutical Processes
Author: Frederick J. Carleton
Publisher: Marcel Dekker
ISBN:
Category : Medical
Languages : en
Pages : 728
Book Description
Publisher: Marcel Dekker
ISBN:
Category : Medical
Languages : en
Pages : 728
Book Description
Pharmaceutical Process Validation, Second Edition
Author: Ira R. Berry
Publisher: CRC Press
ISBN:
Category : Medical
Languages : en
Pages : 658
Book Description
The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.
Publisher: CRC Press
ISBN:
Category : Medical
Languages : en
Pages : 658
Book Description
The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.
Pharmaceutical Process Validation
Author: Bernard T. Loftus
Publisher: Marcel Dekker
ISBN:
Category : Business & Economics
Languages : en
Pages : 320
Book Description
Publisher: Marcel Dekker
ISBN:
Category : Business & Economics
Languages : en
Pages : 320
Book Description
Guideline on General Principles of Process Validation
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
Book Description
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
Book Description