Equipment Qualification in the Pharmaceutical Industry provides guidance that needs to be included in quality qualification programs. The book outlines guidelines for the preparation and execution of qualification protocols, including Installation (IQ), Operational (OQ), and Performance (PQ) factors. In addition, it discusses the importance of related qualification programs (e.g., computer system and cleaning) and how to incorporate them into a fully compliant qualification program. Further, it provides matrices of what could be included for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the examples, matrices, and integration of related systems. Incorporates good manufacturing processes into a compliant qualification programProvides examples of protocol layoutIncludes matrices for major process equipment, installation quality, operational quality, and performance quality requirements INDICE: 1. Introduction 2. Documentation - Getting Ready 3. Quality Systems 4. Equipment Design Considerations 5. Equipment Controls 6. Protocol Preparation 7. Commissioning and Decommissioning 8. Equipment Checklist 9. Protocol Execution 10. Protocol Reports Appendix A. Definitions B. Examples C. References
- ISBN: 978-0-12-817568-2
- Editorial: Academic Press
- Encuadernacion: Rústica
- Páginas: 267
- Fecha Publicación: 01/08/2019
- Nº Volúmenes: 1
- Idioma: Inglés