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Principles of parenteral solution va...

Gorsky, Igor,

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Principles of parenteral solution validation = a practical lifecycle approach /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Principles of parenteral solution validation/ edited 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.
[NT 15003449]:	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
Subject:	Parenteral solutions - Quality control. -
Online resource:	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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020 $a 9780128094129
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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.
260 $a London, United Kingdom : $b Academic Press, $c 2020.
300 $a 1 online resource.
490 1 $a Expertise in pharmaceutical process technology series
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
650 0 $a Parenteral solutions $x Quality control. $3 3509699
650 0 $a Drugs $x Standards. $3 1530650
650 0 $a Drug development. $3 716904
650 1 2 $a Drug Development. $3 3509700
650 1 2 $a Drug Development $x standards. $3 3509701
650 2 2 $a Quality Control. $3 601139
655 4 $a Electronic books. $2 lcsh $3 542853
700 1 $a Gorsky, Igor, $e editor. $3 3509697
700 1 $a Baseman, Harold, $d 1956- $e editor. $3 3509698
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856 4 0 $u https://www.sciencedirect.com/science/book/9780128094129