Validation Lifecycle

The bioprocess validation lifecycle involves qualification, process validation and continued process verification. During qualification, facilities, utilities and equipment are evaluated to ensure they are suitable for intended use. Process validation demonstrates the process is capable of consistently producing quality product meeting predetermined requirements. Three validation batches are typically produced to confirm reproducibility and consistent performance of the process. Continued process verification involves ongoing monitoring and assessment to ensure no changes impact quality. Any modifications are revalidated to maintain process understanding and control.

Process Characterization

Thorough process characterization is fundamental to understanding key parameters and their impact on quality attributes. Characterization studies identify critical process parameters and source materials that could influence safety or efficacy. The design space is established based on an understanding of allowable ranges for critical parameters. Parameters are closely monitored and controlled during commercial manufacturing. Any excursions from the established ranges are thoroughly investigated. Process characterization facilitates continuous improvement as process knowledge evolves.

Cleaning Validation

A robust cleaning Bioprocess Validation program is necessary to prevent cross-contamination which could compromise patient safety. The approach involves qualifying cleaning agents and methods, defining acceptance criteria and implementing cleaning procedures and controls. Initial validation demonstrates cleaning procedures adequately remove residues and contaminants from equipment and facilities. Ongoing monitoring ensures continued effectiveness. Corrective actions are taken if residues exceed pre-defined action limits. Revalidation may be required after modifications to cleaning agents, equipment or facilities. Carefully designed cleaning validation provides assurance of product purity and quality.

Equipment Qualification

Equipment selection, operational qualification and performance qualification are essential elements of a comprehensive equipment qualification strategy. Appropriate equipment must be identified based on product and process requirements. Operational qualification evaluates if equipment is installed and operates per design specifications. Performance qualification confirms the equipment functions as intended under actual operating conditions. Qualification provides confidence equipment performance will not adversely impact quality attributes or reproducibility. Recurrent qualification maintains equipment suitability over the equipment lifecycle. A state of control is established through a rigorous qualification program.

Process Automation Validation

As process automation and digital technologies are increasingly adopted, related systems must undergo validation to ensure proper design, operation and cybersecurity. Computer system validation involves confirming software requirements and design match user needs, establishing that the system performs as intended and maintaining system control over modifications, upgrades, backups and recovery. Control system validation evaluates if the control strategy maintains process parameters within predetermined limits. Network and security validation protects electronic records and data. Lifecycle activities like revalidation after changes demonstrate continued process reliability and data integrity.

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