Author:
Publisher:
ISBN: 9780113207701
Category : Medical instruments and apparatus
Languages : en
Pages : 28

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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: 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: Great Britain. Dept. of Health
Publisher:
ISBN: 9780113213412
Category : Medical instruments and apparatus
Languages : en
Pages : 79

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Book Description

Author: European Confederation of Medical Suppliers Associations
Publisher:
ISBN:
Category : Equipment safety
Languages : en
Pages : 23

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Book Description

Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 26

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Book Description
This Standard specifies the general requirements of production and quality management for sterile medical devices and the components and parts. Production of primary package material of sterile medical devices shall also need to meet the requirements of this Standard.

Author:
Publisher:
ISBN:
Category : Diagnosis, Laboratory
Languages : en
Pages : 48

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Book Description

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: John Sharp
Publisher: Interpharm CRC
ISBN: 9781574911374
Category : Medical
Languages : en
Pages : 80

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Book Description
The new edition of the best-selling Quality Rules series is the perfect introduction to Good Manufacturing Practice (GMP) as they relate to the manufacture of medical devices. Drawing significantly on 21 CFR Part 820, the Quality System Regulation for Medical Devices, Quality Rules in Medical Device Manufacture is the ideal training, retraining, and reinforcement resource for workers recently hired into the medical device industry. This handy, easy-to-read booklet covers all the medical device GMP concepts required by the US FDA, the British MCA, and the European GMPs. In a simple, no-nonsense manner, the author explains the rationale of GMP and the key role played by workers in the production and packaging of pure, safe, and quality medical devices.