Author:
Publisher:
ISBN: 9780113207701
Category : Medical instruments and apparatus
Languages : en
Pages : 28
Book Description
Guide to Good Manufacturing Practice for Sterile Medical Devices and Surgical Products
Author:
Publisher:
ISBN: 9780113207701
Category : Medical instruments and apparatus
Languages : en
Pages : 28
Book Description
Publisher:
ISBN: 9780113207701
Category : Medical instruments and apparatus
Languages : en
Pages : 28
Book Description
Guide to Good Manufacturing Practice for Sterile Medical Devices
Author: EUCOMED.
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 25
Book Description
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 25
Book Description
Guide to Good Manufacturing Practice for Sterile Single Use Medical Devices
Author: Great Britain. Department of Health and Social Security
Publisher:
ISBN: 9780113207169
Category : Disposable medical devices
Languages : en
Pages : 29
Book Description
Publisher:
ISBN: 9780113207169
Category : Disposable medical devices
Languages : en
Pages : 29
Book Description
Guide to Good Manufacturing Practice for Sterile Medical
Author: Dhss
Publisher:
ISBN:
Category :
Languages : en
Pages : 27
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.
Publisher:
ISBN:
Category :
Languages : en
Pages : 27
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.
Sterile Manufacturing
Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406091
Category : Technology & Engineering
Languages : en
Pages : 206
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.
Publisher: CRC Press
ISBN: 1000406091
Category : Technology & Engineering
Languages : en
Pages : 206
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.
Good Manufacturing Practice (GMP) Guidelines
Author: Mindy J. Allport-Settle
Publisher: Pharmalogika
ISBN: 9780982147603
Category : Law
Languages : en
Pages : 686
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.
Publisher: Pharmalogika
ISBN: 9780982147603
Category : Law
Languages : en
Pages : 686
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.
Sterile Manufacturing
Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406121
Category : Medical
Languages : en
Pages : 148
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.
Publisher: CRC Press
ISBN: 1000406121
Category : Medical
Languages : en
Pages : 148
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.
Guide to Good Manufacturing Practice for Sterile and Non-sterile Surgical Products
Author: European Confederation of Medical Suppliers Associations
Publisher:
ISBN:
Category : Equipment safety
Languages : en
Pages : 23
Book Description
Publisher:
ISBN:
Category : Equipment safety
Languages : en
Pages : 23
Book Description
Sterile Medical Devices
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 462
Book Description
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 462
Book Description
EC Guide to Good Manufacturing Practice for Medicinal Products and Active Pharmaceutical Ingredients
Author: Gert Auterhoff
Publisher: Editio Cantor
ISBN:
Category : Business & Economics
Languages : en
Pages : 208
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.
Publisher: Editio Cantor
ISBN:
Category : Business & Economics
Languages : en
Pages : 208
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.