by Bioprocess validation is the process of collecting and evaluating data to determine whether a bioprocess consistently operates within predetermined acceptable specifications and quality standards. The objective of bioprocess validation is to demonstrate that a specific process will consistently yield intermediate or finished products that meet predetermined acceptance criteria and quality attributes. Validation should establish scientifically sound criteria or attributes that will ensure the quality, safety, and efficacy of the biopharmaceutical product.
Risk Assessment and Process Design
Prior to bioprocess validation, a thorough risk assessment should be conducted to identify potential sources of variability and product quality risks posed by the manufacturing process. This risk assessment helps in process design and identifies critical process parameters and quality attributes that require extensive monitoring and control. The process is designed keeping in mind parameters like temperature, pressure, pH and other factors and their impact on product quality. Bioprocess Validation Critical process parameters are identified and tightly controlled during the validation process.
Qualification of Equipment and Facilities
All equipment and facilities that can influence the process or product quality should be properly qualified before use. Installation qualification includes confirming that the equipment is properly installed according to manufacturer specifications and drawings. Operational qualification includes confirming that the equipment operates within pre-set criteria and specifications. Performance qualification includes verifying that the equipment performs as intended over time and consistent with product specifications. Facilities should also undergo qualification to ensure they can maintain protocols like temperature, humidity etc. within pre-set limits.
Process Validation Protocol and Studies
A detailed bioprocess validation protocol outlines the validation approach, studies to be performed, study design, sampling plans, test methods, acceptance criteria etc. Process validation generally involves three stages – process design qualification, process performance qualification and continued process verification. In the design qualification stage, experiments are conducted to ensure the capability of the process to achieve pre-set specifications. Performance qualification involves assessment of control strategies, identification of sources of variability and process robustness. Final validation lots are also manufactured at this stage and samples tested against pre-set criteria. Continued process verification involves periodic evaluation to ensure that the process remains in a state of control.
Process Characterization and Monitoring
Thorough process characterization studies help understand a process and identify critical sources of variability. Statistical tools are used to identify key process parameters and their acceptable ranges. Critical quality attributes that impact product safety, efficacy and stability are identified. In-process controls and real-time monitoring systems are established to ensure the process remains within pre-defined operating limits. Parameters like temperature, agitation rates, pH etc. are closely monitored during validation runs. Samples are taken at pre-determined intervals for release and characterization testing.
Analytical Method Validation
Analytical methods used for testing of process intermediates and finished products during and after manufacturing need to be scientifically sound, accurate, specific, robust and capable of consistently quantifying components of interest. Method validation establishes method performance characteristics like specificity, accuracy, precision, limit of detection, limit of quantitation, linearity and range. Specified acceptance criteria for each validation characteristic are established. The methods should be shown to be stability-indicating and capable of separating process or product-related impurities.
Process Validation Conclusion
A robust bioprocess validation demonstrates that a bioprocess is scientifically sound, repeatable and performs per predetermined acceptance criteria to consistently deliver a product meeting predetermined specifications. It provides a high degree of assurance in the process and establishes the basis for continued process monitoring and verification. Process validation along with appropriate in-process controls, input material controls and analytical testing helps ensure production of biopharmaceutical intermediates and products meeting quality standards.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
About Author - Ravina Pandya
Ravina Pandya, a content writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemicals and materials, etc. With an MBA in E-commerce, she has expertise in SEO-optimized content that resonates with industry professionals. LinkedIn Profile
