Validation
Preface
This document is intended to give a detailed description of the validation activities typical for Scanbur’s air-flow units like Airshower, LAF units, Downflow modules etc.
Overview of validations activities
The objective of this section is to present an overview of the qualifications and validation activities offered by Scanbur.
The extent of validation will always be determined in close co-operation between Scanbur and the customer. If possible the extent of the testing is based on a risk assessment and failure analysis of the operations performed in the Scanbur unit.
Generally the qualification done by Scanbur will verify proper function of the equipment, with respect to customer requirements and specifications, and ensure cGMP and GLP compliance.
Scanbur is always prepared to guide the customer in choosing the right validation concept for the unit in question.
Validation packages
As a standard Scanbur can deliver 3 validation packages. An overview of the validation packages is presented in the table below. For more detailed description please refer to the following sections.
Validation package |
Description |
STANDARD
(included as standard) | Scanbur delivers a technical dossier for the unit, including documented testing of critical process and functional requirements with respect to cGMP and GLP |
EXTENDED | Scanbur will supply a test plan for Factory and Site Acceptance Test and additional acceptance test reporting. The FAT and SAT is conducted and documented on a high level to be directly included and referenced in the formal IQ, OQ, performed by the customer. The documented testing meets requirements for equipment placed under FDA inspection, GLP, or inspection from local health authorities |
FULL | Scanbur delivers a Quality Activity Plan including time schedule, test planning, a list of deliverables and complete documentation for DQ (Design Qualification). Documented testing of equipment placed under FDA inspection or GLP. The level of documentation to meet requirements for IQ, OQ, performed by the customer |