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Equipment qualification in the pharmaceutical industry /
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 c...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London :
Academic Press,
[2019]
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| Colección: | Aspects of pharmaceutical manufacturing series.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Front Cover; Equipment Qualification in The Pharmaceutical Industry; Copyright; Dedication; Contents; Acknowledgments; Introduction to aspects in pharmaceutical manufacturing; Chapter One: Introduction; Compliance; Qualification; Validate/validation; Types of qualification; The order of the qualification process; Chapter Two: Getting ready: Documentation; Overview; Documentation; Document specifics; Validation master plan; Drawings; Manuals; SOPs; Operations/vendors/others; Summary; Chapter Three: Quality systems; Quality risk management; Change control; Investigations
- Corrective action-Preventive actionCalibration/metrology; Preventive maintenance; Cleaning; Document control; Re-qualification; Chapter Four: Equipment design considerations; Materials of construction; Location; Cleaning and maintenance; Other considerations; Chapter Five: Equipment controls and automation; Structural qualification; Functional qualification; Black box, gray box, white box qualifications; IQ/OQ for computer or automated systems; Part 11; Summary; Chapter Six: Preparing the protocols: General approach; Protocol development; Layout; Stand-alone conditions; Acceptance criteria
- Protocol reviewChapter Seven: Commissioning and decommissioning; FAT and SAT; Commissioning; Using commissioning data; Decommissioning; Chapter Eight: Equipment qualification protocols; Product contact; Criticality; Safety; System suitability; Environmental conditions; Protocols; Installation qualification; Operational qualification; Performance qualification; Protocol review; Chapter Nine: Equipment checklists; Chapter Ten: Protocol execution; Prioritization; Good documentation practices; Test instruments; Putting it all together; First steps; Second steps; Third steps
- Handling deviations in the protocolPoints to remember; Summary of protocol execution; Chapter Eleven: Protocol reports; Preparing the report; Each section; Approval page; Purpose/scope; Conclusions; Results; Discussion; Deviations log; Appendix A: Definitions and abbreviations; Appendix B: Preparing a Qualification Protocol; Appendix C : References; Index; Back Cover