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Equipment qualification in the pharmaceutical industry

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Equipment qualification in the pharmaceutical industry/ Steven Ostrove.
作者:	Ostrove, Steven A.,
出版者:	London :Academic Press, : 2019.,
面頁冊數:	1 online resource :col. ill.
內容註:	Front Cover; Equipment Qualification in The Pharmaceutical Industry; Copyright; Dedication; Contents; Acknowledgments; Introduction to aspects in pharmaceutical manufacturing; Chapter One: Introduction; Compliance; Qualification; Validate/validation; Types of qualification; The order of the qualification process; Chapter Two: Getting ready: Documentation; Overview; Documentation; Document specifics; Validation master plan; Drawings; Manuals; SOPs; Operations/vendors/others; Summary; Chapter Three: Quality systems; Quality risk management; Change control; Investigations
內容註:	Corrective action-Preventive actionCalibration/metrology; Preventive maintenance; Cleaning; Document control; Re-qualification; Chapter Four: Equipment design considerations; Materials of construction; Location; Cleaning and maintenance; Other considerations; Chapter Five: Equipment controls and automation; Structural qualification; Functional qualification; Black box, gray box, white box qualifications; IQ/OQ for computer or automated systems; Part 11; Summary; Chapter Six: Preparing the protocols: General approach; Protocol development; Layout; Stand-alone conditions; Acceptance criteria
內容註:	Protocol reviewChapter Seven: Commissioning and decommissioning; FAT and SAT; Commissioning; Using commissioning data; Decommissioning; Chapter Eight: Equipment qualification protocols; Product contact; Criticality; Safety; System suitability; Environmental conditions; Protocols; Installation qualification; Operational qualification; Performance qualification; Protocol review; Chapter Nine: Equipment checklists; Chapter Ten: Protocol execution; Prioritization; Good documentation practices; Test instruments; Putting it all together; First steps; Second steps; Third steps
內容註:	Handling deviations in the protocolPoints to remember; Summary of protocol execution; Chapter Eleven: Protocol reports; Preparing the report; Each section; Approval page; Purpose/scope; Conclusions; Results; Discussion; Deviations log; Appendix A: Definitions and abbreviations; Appendix B: Preparing a Qualification Protocol; Appendix C : References; Index; Back Cover
標題:	Pharmaceutical technology - Quality control. -
電子資源:	https://www.sciencedirect.com/science/book/9780128175682
ISBN:	9780128175699 (electronic bk.)

Equipment qualification in the pharmaceutical industry
Ostrove, Steven A.,

Equipment qualification in the pharmaceutical industry[electronic resource] /Steven Ostrove. - London :Academic Press,2019. - 1 online resource :col. ill. - Aspects of pharmaceutical manufacturing series. - Aspects of pharmaceutical manufacturing series..

Includes bibliographical references and index.

Front Cover; Equipment Qualification in The Pharmaceutical Industry; Copyright; Dedication; Contents; Acknowledgments; Introduction to aspects in pharmaceutical manufacturing; Chapter One: Introduction; Compliance; Qualification; Validate/validation; Types of qualification; The order of the qualification process; Chapter Two: Getting ready: Documentation; Overview; Documentation; Document specifics; Validation master plan; Drawings; Manuals; SOPs; Operations/vendors/others; Summary; Chapter Three: Quality systems; Quality risk management; Change control; Investigations

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

ISBN: 9780128175699 (electronic bk.)Subjects--Topical Terms:

862993
Pharmaceutical technology
--Quality control.Index Terms--Genre/Form:

542853
Electronic books.

LC Class. No.: RS192

Dewey Class. No.: 615/.19

National Library of Medicine Call No.: 2019 G-986

Equipment qualification in the pharmaceutical industry
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505 0 $a Front Cover; Equipment Qualification in The Pharmaceutical Industry; Copyright; Dedication; Contents; Acknowledgments; Introduction to aspects in pharmaceutical manufacturing; Chapter One: Introduction; Compliance; Qualification; Validate/validation; Types of qualification; The order of the qualification process; Chapter Two: Getting ready: Documentation; Overview; Documentation; Document specifics; Validation master plan; Drawings; Manuals; SOPs; Operations/vendors/others; Summary; Chapter Three: Quality systems; Quality risk management; Change control; Investigations
505 8 $a Corrective action-Preventive actionCalibration/metrology; Preventive maintenance; Cleaning; Document control; Re-qualification; Chapter Four: Equipment design considerations; Materials of construction; Location; Cleaning and maintenance; Other considerations; Chapter Five: Equipment controls and automation; Structural qualification; Functional qualification; Black box, gray box, white box qualifications; IQ/OQ for computer or automated systems; Part 11; Summary; Chapter Six: Preparing the protocols: General approach; Protocol development; Layout; Stand-alone conditions; Acceptance criteria
505 8 $a Protocol reviewChapter Seven: Commissioning and decommissioning; FAT and SAT; Commissioning; Using commissioning data; Decommissioning; Chapter Eight: Equipment qualification protocols; Product contact; Criticality; Safety; System suitability; Environmental conditions; Protocols; Installation qualification; Operational qualification; Performance qualification; Protocol review; Chapter Nine: Equipment checklists; Chapter Ten: Protocol execution; Prioritization; Good documentation practices; Test instruments; Putting it all together; First steps; Second steps; Third steps
505 8 $a Handling deviations in the protocolPoints to remember; Summary of protocol execution; Chapter Eleven: Protocol reports; Preparing the report; Each section; Approval page; Purpose/scope; Conclusions; Results; Discussion; Deviations log; Appendix A: Definitions and abbreviations; Appendix B: Preparing a Qualification Protocol; Appendix C : References; Index; Back Cover
520 $a Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.
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