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Author: Phil Cloud
Publisher: CRC Press
ISBN: 9781574910988
Category : Medical
Languages : en
Pages : 375
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Book Description
All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation document be established and followed. Yet these regulations do not provide guidelines on how to produce documentation such as qualification protocols. How to Develop and Manage Qualification Protocols for FDA Compliance focuses specifically on the FDA documentation requirements, providing concrete guidance on how to develop and manage qualification protocols and their associated documentation to ensure your company is not at risk. Key function areas, such as cleaning, facilities and utilities, equipment, computers and software, and process are discussed in detail. The book contains 35 validation procedures and 30 forms that can be used to establish a validation documentation system and provides protocol templates you can use as your own. Numerous diagrams and graphics are used to illustrate key points. Most importantly, this book will provides hands-on, "been there" advice on how to: Write protocols and final reports Develop protocol formats and style guides Establish a documentation review and approval system Implement document control and forms control programs Migrate your documentation system from paper to electronic format If your responsibilities include writing and managing qualification protocols for drug products and related industries, here's all you need to build a cost-effective, manageable--and compliant--system.
Author: Phil Cloud
Publisher: CRC Press
ISBN: 9781574910988
Category : Medical
Languages : en
Pages : 375
Get Book Here
Book Description
All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation document be established and followed. Yet these regulations do not provide guidelines on how to produce documentation such as qualification protocols. How to Develop and Manage Qualification Protocols for FDA Compliance focuses specifically on the FDA documentation requirements, providing concrete guidance on how to develop and manage qualification protocols and their associated documentation to ensure your company is not at risk. Key function areas, such as cleaning, facilities and utilities, equipment, computers and software, and process are discussed in detail. The book contains 35 validation procedures and 30 forms that can be used to establish a validation documentation system and provides protocol templates you can use as your own. Numerous diagrams and graphics are used to illustrate key points. Most importantly, this book will provides hands-on, "been there" advice on how to: Write protocols and final reports Develop protocol formats and style guides Establish a documentation review and approval system Implement document control and forms control programs Migrate your documentation system from paper to electronic format If your responsibilities include writing and managing qualification protocols for drug products and related industries, here's all you need to build a cost-effective, manageable--and compliant--system.
Author: Phillip A. Cloud
Publisher:
ISBN: 9780367804237
Category : MEDICAL
Languages : en
Pages : 375
Get Book Here
Book Description
All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation document be established and followed. Yet these regulations do not provide guidelines on how to produce documentation such as qualification protocols.How to Develop and Manage Qualification Protocols for FDA Compliance focuses specifically on the FDA documentation requirements, providing concrete guidance on how to develop and manage qualification protocols and their associated documentation to ensure your company is not at risk.Key function areas, such as cleaning, facilities and utilities, equipment, computers and software, and process are discussed in detail. The book contains 35 validation procedures and 30 forms that can be used to establish a validation documentation system and provides protocol templates you can use as your own. Numerous diagrams and graphics are used to illustrate key points.Most importantly, this book will provides hands-on, "been there" advice on how to:Write protocols and final reportsDevelop protocol formats and style guidesEstablish a documentation review and approval systemImplement document control and forms control programsMigrate your documentation system from paper to electronic formatIf your responsibilities include writing and managing qualification protocols for drug products and related industries, here's all you need to build a cost-effective, manageable--and compliant--system.
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
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Book Description
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 28
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Book Description
Author: Bernard T. Loftus
Publisher: Marcel Dekker
ISBN:
Category : Business & Economics
Languages : en
Pages : 320
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Book Description
Author: Phillip A. Cloud
Publisher:
ISBN: 9780367802998
Category : MEDICAL
Languages : en
Pages : 443
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Book Description
While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.
Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 1420009419
Category : Medical
Languages : en
Pages : 1145
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Book Description
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati
Author: Orlando López
Publisher: CRC Press
ISBN: 1135488754
Category : Medical
Languages : en
Pages : 287
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Book Description
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places
Author: Anton Bespalov
Publisher: Springer Nature
ISBN: 3030336565
Category : Cardiology
Languages : en
Pages : 424
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Book Description
This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.
Author: Vera Mihajlovic-Madzarevic
Publisher: John Wiley & Sons
ISBN: 0470920882
Category : Medical
Languages : en
Pages : 186
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Book Description
A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
