Applying V Model used in Biotech Industry Computerized System Validation
| Autor: | Hui-chun Hsu, 許惠鈞 |
|---|---|
| Rok vydání: | 2011 |
| Druh dokumentu: | 學位論文 ; thesis |
| Popis: | 99 Biologics products covering vaccines, cellular and gene therapy products, blood & blood products and complex treatment products that are different from other products, any quality concerns or issues, will harm the user or the patient's health or even cause serious effects. Therefore, the national government agencies for the regulation of these products have many specifications the most important thing is GMP (GMP Good Manufacture Practices). These regulations not only the manufacturing units of the process flow, analysis processes, instruments and equipment, but also cover product-related computerized equipment, must complete validation work to ensure that drug purity, characteristics, safety, potency, quality. Computerized system is applying in the biopharmaceutical industry more and more widely, from firmware of small equipment to computer’s hardware and software of an instrument of analyzing the chemical content of products, or an equipment of controlling the flow rate of liquid materials in processes and also monitoring the concentration. All of them need computer to manage. Furthermore, main frame systems can be used to across different departments, such as material inventory management and electronic document for quality management. This research is mainly integrated regulatory requirements, system testing, management, and construction validation process to develop a system to meet specifications of PIC / S GMP, FDA 21CFR Part 11; use V-Model to build up a quality management system. The study also develops an electronic document management system for this case to do an examples of the verification and validation, and complete the relevant requirements of the system specifications, design specifications, system testing, verification and validation of the work; more important is all developed documents are in compliance with GMP factory inspection requirements, but also look forward to all of document and information can be output by this system before new drug license. |
| Databáze: | Networked Digital Library of Theses & Dissertations |
| Externí odkaz: |
|