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Cover: 9780128175682 | Equipment Qualification in the Pharmaceutical Industry | Ostrove
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Equipment Qualification in the Pharmaceutical Industry
Taschenbuch von Steven Ostrove
Sprache: Englisch

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Lieferzeit 4-7 Werktage

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Beschreibung
Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems.

Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems.

Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

Inhaltsverzeichnis
1. Introduction2. Documentation - Getting Ready 3. Quality Systems4. Equipment Design Considerations5. Equipment Controls and Automation6. Preparing the Protocols - General Approach7. Commissioning & Decommissioning8. Equipment Qualification Protocols9. Equipment Checklist10. Protocol Execution11. Protocol Reports

AppendixA. DefinitionsB. ExamplesC. References

Details
Erscheinungsjahr: 2019
Medium: Taschenbuch
Inhalt: Kartoniert / Broschiert
ISBN-13: 9780128175682
ISBN-10: 0128175680
Sprache: Englisch
Herstellernummer: C2018-0-02455-X
Autor: Ostrove, Steven
Hersteller: Academic Press
Elsevier Science & Technology
Verantwortliche Person für die EU: Zeitfracht Medien GmbH, Ferdinand-Jühlke-Str. 7, D-99095 Erfurt, produktsicherheit@zeitfracht.de
Maße: 11 x 152 x 229 mm
Von/Mit: Steven Ostrove
Erscheinungsdatum: 14.06.2019
Gewicht: 0,36 kg
Artikel-ID: 115965370
Inhaltsverzeichnis
1. Introduction2. Documentation - Getting Ready 3. Quality Systems4. Equipment Design Considerations5. Equipment Controls and Automation6. Preparing the Protocols - General Approach7. Commissioning & Decommissioning8. Equipment Qualification Protocols9. Equipment Checklist10. Protocol Execution11. Protocol Reports

AppendixA. DefinitionsB. ExamplesC. References

Details
Erscheinungsjahr: 2019
Medium: Taschenbuch
Inhalt: Kartoniert / Broschiert
ISBN-13: 9780128175682
ISBN-10: 0128175680
Sprache: Englisch
Herstellernummer: C2018-0-02455-X
Autor: Ostrove, Steven
Hersteller: Academic Press
Elsevier Science & Technology
Verantwortliche Person für die EU: Zeitfracht Medien GmbH, Ferdinand-Jühlke-Str. 7, D-99095 Erfurt, produktsicherheit@zeitfracht.de
Maße: 11 x 152 x 229 mm
Von/Mit: Steven Ostrove
Erscheinungsdatum: 14.06.2019
Gewicht: 0,36 kg
Artikel-ID: 115965370
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