Charm Bioengineering, Inc. | Validation Procedures

Validation Procedures

The concept of validation applies to all operations that are devoted to remove or inactivate virus: it has to demonstrate the reliability of the respective unit operation in order to achieve the required product quality in a reproducible manner.

The validation procedure is a complex of different routines which are complementary to each other:

Standard operating procedures SOP's	Standard test procedures STP's
Process Qualification: Installation Qualification IQ Operational Qualification OQ Performance Qualification PQ	Process Validation: Process Description Risk Analysis Data Evaluation and Documentation

Components of the validation procedure

The initial procedure for validation of process hardware is an installation qualification (IQ) which verifies the equipment installation, the inspection of utility connections, the compliance with given specifications and standards and compliance of the actual design with the purchase specifications. Operational qualification (OQ) includes purpose and design characteristics of the installed equipment, acceptance criteria for system function and performance as well as the determination of process parameters and process monitoring. Performance qualification (PQ) has to demonstrate the reliability of the equipment with respect to an effective and reproducible process leading to a (intermediate) product which meets all set release criteria.

More About Validation
Validation of Viral Clearance
Calculation of the Clearance Factor
Model Viruses
Standard operating procedures (SOP's) have to be defined for any handling of the equipment, including set up, operation, regeneration, cleaning and sanitization or sterilisation as well as maintenance and calibration. Standard test procedures (STP's) describe respective in-process controls, accordingly specifications and rejection criteria have to be defined. The validation of the unit operation itself consists of a detailed process description, a risk analysis of the process, and evaluation and documentation of process data.