Principles of parenteral solution validation: a practical lifecycle approach
Gespeichert in:
| Weitere Verfasser: | , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
London, United Kingdom ; San Diego, CA, United States ; Cambridge, MA, United States ; Kidlington, Oxford, United Kingdom
Academic Press
[2020]
|
| Schriftenreihe: | Expertise in pharmaceutical process technology series
|
| Schlagworte: | |
| Online-Zugang: | TUM01 |
| Beschreibung: | 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 |
| Beschreibung: | 1 Online-Ressource (xviii, 280 Seiten) |
| ISBN: | 9780128094464 012809446X |
Internformat
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| 245 | 1 | 0 | |a Principles of parenteral solution validation |b a practical lifecycle approach |c edited by Igor Gorsky, Harold S. Baseman |
| 264 | 1 | |a London, United Kingdom ; San Diego, CA, United States ; Cambridge, MA, United States ; Kidlington, Oxford, United Kingdom |b Academic Press |c [2020] | |
| 300 | |a 1 Online-Ressource (xviii, 280 Seiten) | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b c |2 rdamedia | ||
| 338 | |b cr |2 rdacarrier | ||
| 490 | 0 | |a Expertise in pharmaceutical process technology series | |
| 500 | |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 | 4 | |a Parenteral solutions / Quality control | |
| 650 | 4 | |a Drugs / Standards | |
| 650 | 4 | |a Drug development | |
| 700 | 1 | |a Gorsky, Igor |4 edt | |
| 700 | 1 | |a Baseman, Harold S. |d 1956- |0 (DE-588)1230355065 |4 edt | |
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Datensatz im Suchindex
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| author2 | Gorsky, Igor Baseman, Harold S. 1956- |
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| author_GND | (DE-588)1230355065 |
| author_facet | Gorsky, Igor Baseman, Harold S. 1956- |
| building | Verbundindex |
| bvnumber | BV046843150 |
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| ctrlnum | (ZDB-4-NLEBK)1145076 (OCoLC)1193311446 (DE-599)BVBBV046843150 |
| dewey-full | 615.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.19 |
| dewey-search | 615.19 |
| dewey-sort | 3615.19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| discipline_str_mv | Medizin |
| format | Electronic eBook |
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| id | DE-604.BV046843150 |
| illustrated | Not Illustrated |
| index_date | 2024-07-03T15:08:18Z |
| indexdate | 2024-07-10T08:55:23Z |
| institution | BVB |
| isbn | 9780128094464 012809446X |
| language | English |
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| oclc_num | 1193311446 |
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| physical | 1 Online-Ressource (xviii, 280 Seiten) |
| psigel | ZDB-4-NLEBK ZDB-4-NLEBK TUM_PDA_EBSCOMED_Kauf |
| publishDate | 2020 |
| publishDateSearch | 2020 |
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| publisher | Academic Press |
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| series2 | Expertise in pharmaceutical process technology series |
| spelling | Principles of parenteral solution validation a practical lifecycle approach edited by Igor Gorsky, Harold S. Baseman London, United Kingdom ; San Diego, CA, United States ; Cambridge, MA, United States ; Kidlington, Oxford, United Kingdom Academic Press [2020] 1 Online-Ressource (xviii, 280 Seiten) txt rdacontent c rdamedia cr rdacarrier 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 Parenteral solutions / Quality control Drugs / Standards Drug development Gorsky, Igor edt Baseman, Harold S. 1956- (DE-588)1230355065 edt Erscheint auch als Druck-Ausgabe 978-0-12-809412-9 |
| spellingShingle | Principles of parenteral solution validation a practical lifecycle approach Parenteral solutions / Quality control Drugs / Standards Drug development |
| title | Principles of parenteral solution validation a practical lifecycle approach |
| title_auth | Principles of parenteral solution validation a practical lifecycle approach |
| title_exact_search | Principles of parenteral solution validation a practical lifecycle approach |
| title_exact_search_txtP | Principles of parenteral solution validation a practical lifecycle approach |
| title_full | Principles of parenteral solution validation a practical lifecycle approach edited by Igor Gorsky, Harold S. Baseman |
| title_fullStr | Principles of parenteral solution validation a practical lifecycle approach edited by Igor Gorsky, Harold S. Baseman |
| title_full_unstemmed | Principles of parenteral solution validation a practical lifecycle approach edited by Igor Gorsky, Harold S. Baseman |
| title_short | Principles of parenteral solution validation |
| title_sort | principles of parenteral solution validation a practical lifecycle approach |
| title_sub | a practical lifecycle approach |
| topic | Parenteral solutions / Quality control Drugs / Standards Drug development |
| topic_facet | Parenteral solutions / Quality control Drugs / Standards Drug development |
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