Guide to Good Manufacturing Practice for Sterile Medical Devices and Surgical Products PDF Download
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Author:
Publisher:
ISBN: 9780113207701
Category : Medical instruments and apparatus
Languages : en
Pages : 28
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Book Description
Author:
Publisher:
ISBN: 9780113207701
Category : Medical instruments and apparatus
Languages : en
Pages : 28
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Book Description
Author: EUCOMED.
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 25
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Book Description
Author: Great Britain. Department of Health and Social Security
Publisher:
ISBN: 9780113207169
Category : Disposable medical devices
Languages : en
Pages : 29
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Book Description
Author: Dhss
Publisher:
ISBN:
Category :
Languages : en
Pages : 27
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Book Description
The purpose of this guide is thus to provide a framework on which individual manufacturers can build the necessary and appropriate structures to ensure that their products are of the nature and quali- ty intended. The guide is particulary concerned with those aspects of manufacturing conditions and processes which may affect the quality, safety and performance of the product.
Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406091
Category : Technology & Engineering
Languages : en
Pages : 206
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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.
Author: Mindy J. Allport-Settle
Publisher: Pharmalogika
ISBN: 9780982147603
Category : Law
Languages : en
Pages : 686
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Book Description
This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.
Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406121
Category : Medical
Languages : en
Pages : 148
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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.
Author: European Confederation of Medical Suppliers Associations
Publisher:
ISBN:
Category : Equipment safety
Languages : en
Pages : 23
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Book Description
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 462
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Book Description
Author: Gert Auterhoff
Publisher: Editio Cantor
ISBN:
Category : Business & Economics
Languages : en
Pages : 208
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Book Description
Among other issues, the edition deals with: quality management, personnel, premises and equipment, documentation, production, quality control, contract manufacture and analysis, complaints and product recall, selfinspection. Book jacket.
