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Standard Operation Procedures (SOP) documentation details
Backup SOP
This SOP describes the procedure for making backups of the files created in/by UNICORN™. The SOP ensures that no data are lost in case of a hard disk failure on the computer used to run the chromatography system.
Restore SOP
This is not a SOP in terms of a regularly performed standard operation, but rather a step-by-step instruction describing what to do in case of a computer hard disk crash. The Restore SOP describes the procedure to restore files from a backup. For other disturbances, the SOP for Change Control Procedures should be used.
Revalidation SOP
Revalidations are also called Re-evaluations, and a regulatory requirement calls for frequent performance, though "frequent" is not defined. It is generally accepted that revalidations are performed on a yearly basis. The main part of the Revalidation SOP is the revalidation protocol that is to be followed when performing a revalidation.
Audit Trail SOP
It is a regulatory demand that Audit Trail files are created, handled and stored correctly. The Audit Trail SOP describes how this can be done. The UNICORN generated Audit Trail files are printed weekly and placed in a binder for this purpose.
System Security SOP
This SOP addresses access to BioProcess™ system software. The SOP describes the handling of the system and not the setup of the system security. The setup of the system security is defined in the Installation Qualification (IQ). The system security is tested in the Operational Qualification (OQ) and by GE Healthcare.
Logbook SOP
This SOP addresses the handling and entries made in the system logbook. The purpose is to create a simple document that describes, in chronological order, events occurring in the system that may have an effect on production. According to regulatory publications, all production equipment must have a logbook for all activities that affect the system and possibly also the pharmaceutical process.
ÄKTApilot System Wetted Parts Replacement SOP and BioProcess System Wetted Parts Replacement SOP
When a system is used in production of more than one product (multi-purpose system) an option to often costly and time-consuming cleaning and cleaning validation is to replace the system wetted parts, e.g. tubing, flow cells and valve diaphragms.
This SOP describes the replacement of all wetted parts on ÄKTApilot™ or BioProcess system, the necessary testing after replacements and includes a reusable section to document the replacements made. Note that the BioProcess System Wetted Parts Replacement SOP must be adapted to match the configuration of each specific system it shall be used with.
Chromaflow Packing SOP
This SOP addresses the the packing abd unpacking of Chromaflow™ columns. It also contains protocols for HEPT, asymmetry testing and buffert preparations. |
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