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Principles of parenteral solution va...

Gorsky, Igor,

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Principles of parenteral solution validation = a practical lifecycle approach /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Principles of parenteral solution validation/ edited by Igor Gorsky, Harold S. Baseman.
其他題名:	a practical lifecycle approach /
其他作者:	Gorsky, Igor,
出版者:	London, United Kingdom :Academic Press, : 2020.,
面頁冊數:	1 online resource.
內容註:	1 Process Validation: Design and Planning -- 2 Aseptic Process Validation: Aseptic Process Simulation Design -- 3 Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals -- 4 Equipment Cleaning Process -- 5 Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System -- 6 Use of Statistics in Process Validation -- 7 Process Validation Stage 1: Parenteral Process Design -- 8 Process Validation Stage 2: Parenteral Process Performance Qualification -- 9 Process Validation Stage 3: Continued Process Verification -- 10 Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter -- 11 Environmental Monitoring -- 12 Isolators -- 13 Post Aseptic Fill Sterilization and Lethal Treatment
標題:	Parenteral solutions - Quality control. -
電子資源:	https://www.sciencedirect.com/science/book/9780128094129
ISBN:	9780128094464 (electronic bk.)

Principles of parenteral solution validation = a practical lifecycle approach /
Principles of parenteral solution validationa practical lifecycle approach /[electronic resource] :edited by Igor Gorsky, Harold S. Baseman. - London, United Kingdom :Academic Press,2020. - 1 online resource. - Expertise in pharmaceutical process technology series. - Expertise in pharmaceutical process technology series..

1 Process Validation: Design and Planning -- 2 Aseptic Process Validation: Aseptic Process Simulation Design -- 3 Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals -- 4 Equipment Cleaning Process -- 5 Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System -- 6 Use of Statistics in Process Validation -- 7 Process Validation Stage 1: Parenteral Process Design -- 8 Process Validation Stage 2: Parenteral Process Performance Qualification -- 9 Process Validation Stage 3: Continued Process Verification -- 10 Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter -- 11 Environmental Monitoring -- 12 Isolators -- 13 Post Aseptic Fill Sterilization and Lethal Treatment

ISBN: 9780128094464 (electronic bk.)Subjects--Topical Terms:

3509699
Parenteral solutions
--Quality control.Index Terms--Genre/Form:

542853
Electronic books.

LC Class. No.: RS201.P37

Dewey Class. No.: 615.19

Principles of parenteral solution validation = a practical lifecycle approach /
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