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Principles of parenteral solution va...

Baseman, Harold, (1956-)

Principles of parenteral solution validationa practical lifecycle approach /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Principles of parenteral solution validationedited by Igor Gorsky, Harold S. Baseman.
Reminder of title:	a practical lifecycle approach /
other author:	Gorsky, Igor,
Published:	London, United Kingdom :Academic Press,2020.
Description:	1 online resource.
Subject:	Parenteral solutionsQuality control.
Online resource:	https://www.sciencedirect.com/science/book/9780128094129
ISBN:	9780128094464 (electronic bk.)

Principles of parenteral solution validationa 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:

897196
Parenteral solutions
--Quality control.Index Terms--Genre/Form:

214472
Electronic books.

LC Class. No.: RS201.P37

Dewey Class. No.: 615.19

Principles of parenteral solution validationa practical lifecycle approach /
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245 0 0 $a Principles of parenteral solution validation $h [electronic resource] : $b a practical lifecycle approach / $c edited by Igor Gorsky, Harold S. Baseman.
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505 0 $a 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
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