Sterile manufacturing: regulations, processes, and guidelines
Introduction -- Data integrity compliance -- Risk based life cycle management -- FMEA manufacturing procedure -- Classified areas -- Sterile manufacturing facilities -- Personnel behaviors, personal protective equipment (PPE), and process flow -- Quality approach for systems validation -- Dedicated...
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Boca Raton ; London ; New York
CRC Press, Taylor & Francis Group
2022
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| Schlagworte: | |
| Zusammenfassung: | Introduction -- Data integrity compliance -- Risk based life cycle management -- FMEA manufacturing procedure -- Classified areas -- Sterile manufacturing facilities -- Personnel behaviors, personal protective equipment (PPE), and process flow -- Quality approach for systems validation -- Dedicated facilities -- Contamination -- Containment -- Suppliers -- Single use technologies (SUT) -- Master qualification plan (MQP) -- Water for injection (WFI) -- Integrated facility design -- Sterile techniques -- Compliance -- Controls -- Barriers, isolators, and RABS -- Quality risk management -- Equipment qualification (EQ) -- Process validation -- Change control -- Analytical testing of raw material quality -- Product life cycle -- Quality by design (QbD) -- Sterilization -- Cleaning validation -- Lyophilization |
| Beschreibung: | xv, 189 Seiten Illustrationen, Diagramme |
| ISBN: | 9780367754358 9780367754372 |
Internformat
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| 264 | 1 | |a Boca Raton ; London ; New York |b CRC Press, Taylor & Francis Group |c 2022 | |
| 300 | |a xv, 189 Seiten |b Illustrationen, Diagramme | ||
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| 520 | 3 | |a Introduction -- Data integrity compliance -- Risk based life cycle management -- FMEA manufacturing procedure -- Classified areas -- Sterile manufacturing facilities -- Personnel behaviors, personal protective equipment (PPE), and process flow -- Quality approach for systems validation -- Dedicated facilities -- Contamination -- Containment -- Suppliers -- Single use technologies (SUT) -- Master qualification plan (MQP) -- Water for injection (WFI) -- Integrated facility design -- Sterile techniques -- Compliance -- Controls -- Barriers, isolators, and RABS -- Quality risk management -- Equipment qualification (EQ) -- Process validation -- Change control -- Analytical testing of raw material quality -- Product life cycle -- Quality by design (QbD) -- Sterilization -- Cleaning validation -- Lyophilization | |
| 653 | 0 | |a Drugs / Sterilization | |
| 653 | 0 | |a Pharmaceutical industry / Production standards / United States | |
| 653 | 0 | |a Clean rooms / Standards / United States | |
| 653 | 0 | |a TECHNOLOGY / Manufacturing ; bisacsh | |
| 653 | 0 | |a MEDICAL / Reference ; bisacsh | |
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Datensatz im Suchindex
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| author | Hout, Sam A. 1951- |
| author_GND | (DE-588)1046199161 |
| author_facet | Hout, Sam A. 1951- |
| author_role | aut |
| author_sort | Hout, Sam A. 1951- |
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| building | Verbundindex |
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| ctrlnum | (OCoLC)1322805591 (DE-599)BVBBV047891411 |
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| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.1/9 |
| dewey-search | 615.1/9 |
| dewey-sort | 3615.1 19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| discipline_str_mv | Chemie / Pharmazie Medizin |
| format | Book |
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| id | DE-604.BV047891411 |
| illustrated | Illustrated |
| index_date | 2024-07-03T19:26:18Z |
| indexdate | 2024-07-10T09:24:23Z |
| institution | BVB |
| isbn | 9780367754358 9780367754372 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-033273510 |
| oclc_num | 1322805591 |
| open_access_boolean | |
| owner | DE-19 DE-BY-UBM |
| owner_facet | DE-19 DE-BY-UBM |
| physical | xv, 189 Seiten Illustrationen, Diagramme |
| publishDate | 2022 |
| publishDateSearch | 2022 |
| publishDateSort | 2022 |
| publisher | CRC Press, Taylor & Francis Group |
| record_format | marc |
| spelling | Hout, Sam A. 1951- Verfasser (DE-588)1046199161 aut Sterile manufacturing regulations, processes, and guidelines Sam A. Hout Boca Raton ; London ; New York CRC Press, Taylor & Francis Group 2022 xv, 189 Seiten Illustrationen, Diagramme txt rdacontent n rdamedia nc rdacarrier Introduction -- Data integrity compliance -- Risk based life cycle management -- FMEA manufacturing procedure -- Classified areas -- Sterile manufacturing facilities -- Personnel behaviors, personal protective equipment (PPE), and process flow -- Quality approach for systems validation -- Dedicated facilities -- Contamination -- Containment -- Suppliers -- Single use technologies (SUT) -- Master qualification plan (MQP) -- Water for injection (WFI) -- Integrated facility design -- Sterile techniques -- Compliance -- Controls -- Barriers, isolators, and RABS -- Quality risk management -- Equipment qualification (EQ) -- Process validation -- Change control -- Analytical testing of raw material quality -- Product life cycle -- Quality by design (QbD) -- Sterilization -- Cleaning validation -- Lyophilization Drugs / Sterilization Pharmaceutical industry / Production standards / United States Clean rooms / Standards / United States TECHNOLOGY / Manufacturing ; bisacsh MEDICAL / Reference ; bisacsh Erscheint auch als Online-Ausgabe 978-1-003-16250-6 |
| spellingShingle | Hout, Sam A. 1951- Sterile manufacturing regulations, processes, and guidelines |
| title | Sterile manufacturing regulations, processes, and guidelines |
| title_auth | Sterile manufacturing regulations, processes, and guidelines |
| title_exact_search | Sterile manufacturing regulations, processes, and guidelines |
| title_exact_search_txtP | Sterile manufacturing regulations, processes, and guidelines |
| title_full | Sterile manufacturing regulations, processes, and guidelines Sam A. Hout |
| title_fullStr | Sterile manufacturing regulations, processes, and guidelines Sam A. Hout |
| title_full_unstemmed | Sterile manufacturing regulations, processes, and guidelines Sam A. Hout |
| title_short | Sterile manufacturing |
| title_sort | sterile manufacturing regulations processes and guidelines |
| title_sub | regulations, processes, and guidelines |
| work_keys_str_mv | AT houtsama sterilemanufacturingregulationsprocessesandguidelines |