Validation of the process control system of an automated large scale manufacturing plant
| Autor: | Hans Kremers, Thomas Karrer, Heinz Neuhaus, R.Helge Traut |
|---|---|
| Rok vydání: | 1998 |
| Předmět: |
Drug Industry
business.industry Computer science Scale (chemistry) Software Validation Automation Field (computer science) Test script Validation rule Documentation Risk analysis (business) Computer Systems Systems engineering Molecular Medicine Process control Humans General Pharmacology Toxicology and Pharmaceutics business Serum Albumin |
| Zdroj: | Pharmaceutica acta Helvetiae. 72(6) |
| ISSN: | 0031-6865 |
| Popis: | The validation procedure for the process control system of a plant for the large scale production of human albumin from plasma fractions is described. A validation master plan is developed, defining the system and elements to be validated, the interfaces with other systems with the validation limits, a general validation concept and supporting documentation. Based on this master plan, the validation protocols are developed. For the validation, the system is subdivided into a field level, which is the equipment part, and an automation level. The automation level is further subdivided into sections according to the different software modules. Based on a risk categorization of the modules, the qualification activities are defined. The test scripts for the different qualification levels (installation, operational and performance qualification) are developed according to a previously performed risk analysis. |
| Databáze: | OpenAIRE |
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