Search results for " verification"
Article
Continued Process Verification for Biopharma Manufacturing
48-52
Continued process verification (CPV) is the activity that provides ongoing verification of the performance of a manufacturing process. Guidance issued by FDA in 2011 (1) emphasized the impo…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The first DoE was conducted to explore and identify a preliminary set of chromatographic conditions for further verification. The second DoE was conducted to verify conformance of the method to the AT…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The risk level of the CPP is used to determine the amount of testing so that high-risk CPPs require more replication and rigorous data analysis and low-risk CPPs require a simple verification. Equipme…
Article
The Lifecycle Change of Process Validation and Analytical Testing
Jones (Innopharma Labs): A manufacturer can only truly understand their process and successfully demonstrate continued process verification through the implementation of process analytical testing (PA…
Article
Assessing Manufacturing Process Robustness
All data sets prepared, transposed, and analyzed should be subject to data verification procedures to assure data accuracy and integrity.
Documents required for the assessment include the…
Article
Essentials in Establishing and Using Design Space
Small-scale and at-scale design space verification
Verification runs at both small scale and at scale are used to verify the model. Comparing values from the verification runs to the model hel…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
…riticality, levels of details required in process descriptions and in risk assessments, design-space verification, and changes to non-critical process parameters (non-CPPs).
Other major issues …
Article
Setting Standards for Biotech Therapeutics in India
IPC is in the process of monograph verification stage for rituximab drug substance and drug product and teriparatide drug substance and drug product monographs. Many new general chapters pertaining to…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
This limitation frequently is one of the primary drivers of establishing the continuous process verification (CPV) program in Stage 3 to monitor the future impact from this raw material variation. For…
Article
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
Finally, we would recommend doing a verification of your model because, of course, without demonstrating it is predictive and captures the dynamics, it's not much use. So we do this by looking at the …