Validation of the process control system of an automated large scale manufacturing plant.
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.
Neuhaus
H
H
ZLB Zentrallaboratorium Blutspendedienst SRK, Bern, Switzerland.
Kremers
H
H
Karrer
T
T
Traut
R H
RH
D003199:Computer Systems / Q000592:standards*; D004345:Drug Industry / Q000592:standards*; D006801:Humans; D012709:Serum Albumin / Q000302:isolation & purification; D012986:Software Validation
D012709:Serum Albumin