What is Bioprocess Validation?
Bioprocess validation is the collection and evaluation of data, from the design stage throughout production, which establishes documented evidence that a process is capable of consistently delivering quality products that meet predetermined specifications and quality attributes. It aims to demonstrate that all quality attributes and process parameters are consistently met.
Process Design and Development
The first step in validation involves process design and development activities. Engineers and scientists work to establish the parameters that will produce consistent and high-quality results. This includes determiningideal conditions like temperatures, pressures, mixing rates and hold times. Pilot studies are conducted to verify the design specifications. Any issues identified during this stage can be addressed before moving to large-scale production. Thorough documentation of the design and development work helps support validation of the final commercial manufacturing process.
Equipment Qualification
Once the basic Bioprocess Validation parameters have been identified, equipment used to produce the biologic must be qualified. This involves verifying that equipment is properly designed and installed according to specifications. Performance qualifications (PQ) are conducted to ensure equipment functions as intended under normal operating conditions. Factory acceptance testing may also be necessary prior to equipment installation. Proper cleaning validation helps guarantee that equipment is free of residues between product campaigns.
Process Qualification
With the equipment and facility ready, process performance qualification (PPQ) studies are conducted to verify the entire commercial manufacturing process. These include running three consecutive commercial-scale batches using the validated process and evaluating them to ensure all quality attributes are met. Any necessary adjustments identified during PPQ are implemented and further lots may be produced to confirm the process is properly controlled and consistently delivers conforming product.
Continued Process Verification
Ongoing monitoring and process verification are required as part of a state of control program once initial validation is complete. Additional product batches are manufactured and tested periodically to verify the process remains in a state of control. Trend analysis of process parameters and product quality attributes helps identify potential issues requiring investigation before they impact product quality or safety. Changes to facilities, equipment or processes require requalification as well. Process validation activities help ensure a continued supply of safe and effective biologics.
Proper bioprocess validation following industry standards helps guarantee biopharmaceutical quality from development through commercial production. It provides a high degree of assurance that the process will consistently meet pre-determined specifications and quality standards. A state of control is established and maintained through ongoing monitoring, review and process validation efforts. This rigorous approach helps ensure patient safety, as well as compliance with regulatory requirements for biologic approvals and commercial supply.
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