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: Phillip A. Cloud
Publisher:
ISBN: 9780367804237
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 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: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406091
Category : Technology & Engineering
Languages : en
Pages : 207
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Book Description
This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.
