Search results for " control" in Articles / App Notes
Article
Supply Chain Challenges for Single-Use Systems
The large number of raw materials makes forecasting demand more difficult and requires robust materials management, supplier quality management, quality control, and business continuity planning to en…
Article
Applying GMPs in Stages of Development
Areas to be reviewed to determine the appropriate level of control needed in concert with the phase development stage include: level of validation of test methods, level of detail needed in batch reco…
Article
Using Digital Twins to Model Process Chromatography
In this case, if a model describing the process is extant and describes the process when controlled, data for the out-of-spec chromatogram is fed back into the model. Process parameters are then chang…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Those process analytical technologies (PAT) are a critical part of control strategies that ensure continuous operation within the design space.
While …
Article
Addressing the Complex Nature of Downstream Processing with QbD
Specifications for the drug substance, excipients, and drug product and controls for each manufacturing step are determined through a control strategy. The final elements of QbD are process capability…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…ment and utilities
Outside plant environment
• Specific virus controls in the product manufacturing process:
Virus testing (bulk harvest, drug substance, dru…
Article
Quality by Design and Extractable and Leachable Testing
Confirmation that the supplier has cGMP control over its manufacturing process is essential. Once variability is known, one can assess the impact of this variability on component leachables, and in tu…
Article
Essentials in Establishing and Using Design Space
Product and process control applications
Based on the equations, selection of the control strategy can take place. Process controls can be one of the following: feed-forward, feedback, in-situ…
Article
PDA's Technical Report for Biotech Cleaning Validation
The report uses a life-cycle approach to biotechnology cleaning validation that encompasses design and development, process qualification, and ongoing control of effectiveness. It also considers the r…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Apheresis center capacity, donor network access, sample handling expertise, and quality control systems all contribute to the ability to achieve reproducible starting material quality and efficacy.
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