Telstar has developed a unique integrated strategy including expertise from different disciplines and aligning validation activities with lifecycle concepts. The first element of this approach is process development, where engineering activities like concept design and basic and detailed engineering go hand in hand with Quality Risk Management activities. By using this method, development and technological advances are effectively addressed to ensure quality at early design stages.
In order to achieve a cost effective validation commensurate with risk level, the basic principle is to discern between non-critical and Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), based on science and risk.
Validation activities begin with a high level User Requirement Specification (URS), which will be the key document during the whole validation lifecycle. After defining the URS document, the following stages will be performed: Process User Requirements (PURs) will be assessed early by risk management, specifications and design will be developed and “critical aspects” (risk control design features and functions) will be identified, which are the prevention, mitigation or detection of quality risks to PURs.
Critical aspects will be verified through commissioning and qualification and PURs will be validated through process validation. Variability of CQAs and CPPs will be controlled and it will be verified that the process is capable of reproducible commercial manufacturing, delivering in a consistent and repetitive manner a product that complies with the established specifications.
The goal is a high degree of assurance that meeting all the defined CQAs and CPPs will be achieved. Therefore during routine production, periodic validation status will be reviewed by Continued Process Verification, which is a key element to maintain the process in a state of control.