In the pharmaceutical industry, lifecycle approach of a pharmaceutical product is the very renowned topic now a days. Considering this it is very important to have continuous monitoring of the product throughout the lifecycle, once it is established and validated, for fulfilment of this objective one of the process validation stage i.e. CPV is being used.
Fig. 1: Process performance qualification & Continuous process verification (CPV)
In previous articles, at this platform (TPT) we have taken overview on various aspects of Stage-2 of Process validation i.e. Process performance qualification (PPQ). Now, to have clarity on Continuous process verification (CPV) we will relate the stage-2 and stage-3 of process validation i.e. “PQP” and “CPV.
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"Continuous Process Verification is the bridge that connects initial validation to sustained product quality, ensuring that each batch produced reflects the highest standards set during development. It transforms process monitoring from a compliance obligation into a proactive tool for maintaining excellence in process."
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Here we will go through with the details on;
🔍 How to define Continuous process verification (CPV)?
🔍 Relationship Between PPQ and CPV?
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How to define Continuous process verification (CPV)?
Definition: CPV is the ongoing monitoring and evaluation of the manufacturing process during the commercial phase. It ensures that the process remains in a state of control throughout its lifecycle, meaning it consistently produces products that meet predetermined quality criteria.
The primary goal of CPV is to detect any variations or trends that might indicate a potential deviation from the validated state. It allows for proactive adjustments to maintain product quality and compliance with regulatory requirements.
In crux, Continuous Process Verification (CPV) is to ensure that the manufacturing process remains in a state of control during commercial production. The motive behind CPV is;
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📢 Detect Variability Early
📢 Enable Proactive Adjustments
Relationship Between PPQ and CPV?
PPQ is
essentially the foundation upon which CPV is built.
Both PPQ and CPV are required by regulatory authorities such as the FDA to ensure that pharmaceutical products are manufactured to the highest quality standards.
PPQ demonstrates the initial robustness of the process, CPV ensures that this robustness is maintained over time.
Once the process is validated through PPQ, CPV takes over to ensure that the process remains in control during the commercial manufacturing phase.
Based on the continuous monitoring of commercial manufacturing activity, if CPV identifies trends or variations that suggest potential process drift, this information can be used to refine the process or establish new control strategies during subsequent PPQ activities for similar products.
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Conclusively, CPV and PPQ are integral parts of the process validation lifecycle, along with the process design phase.
Process Performance Qualification (PPQ) lays the foundation for a validated process, while Continued Process Verification (CPV) ensures that this foundation remains strong throughout the lifecycle, safeguarding product quality and compliance with each batch produced.
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Learn More….
What
is Validation? Basic overview
What
is Product Lifecycle Management...? An Overview
What
is Process Validation? What are the Types of validation?
Validation
study: Why Three batch for validation study?
10
Key Steps for Successful Process Validation in Pharma
5
Common Challenges in Pharma Drug substance Process Validation
5 Common Issues Encountered During Process Validation and solutions
 and how does it relate to PPQ?){kind=link}
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