for Drug Products
Manage your drug manufacturing process development
using Quality-By-Design principles.
Quality target product profile
Define the final quality attributes of your product and link these specifications to TPP elements providing traceability to patient safety and efficacy requirements.
Use our Process Builder to define the unit operations of your manufacturing process. Define critical quality attributes, material attributes, and process parameters for each unit operation.
Pictures speak a thousand words with special visualization tools allowing rapid identification of key risks in the manufacturing process and how those risks impact critical quality attributes.
Manage the evolution of your entire process....
Developing drug products is a complicated endeavor. As the complexity of these programs has increased, so has the need for novel software tools to manage these programs using risk-based approaches like quality-by-design. QbDVision is the first cloud-based software solution allowing for the risk-based management of your drug manufacturing process. Start with your Target Product Profile and then build your Quality Target Product Profile defining the quality attributes of the final product. Build your manufacturing process right in our software and identify critical material attributes and process parameters. Then link these to the product final quality attributes and assign risks based on the current knowledge of the process. As your program evolves and your process knowledge increases, the specifications and risks can be revisited and adjusted using science-based justifications supported by data. QbDVision takes you through this journey arriving at a robust, well-controlled manufacturing process.
Target Product Profile
Quality Target Product Profile
....Starting with your Target Product Profile
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
The TPP provides a discussion of the overall intent of your drug development program embodying the notion of beginning with the end in mind. It is an evolving document based on specific guidance facilitating discussions between you and the FDA throughout the drug development process. QbDVision provides the tools you need to
Build your own TPP with predefined fields based on the FDA guidance.
Manage the evolution of the TPP specifications as your process knowledge increases.
Track this evolution electronically with each element managed under version control with approval routing and audit trails.
Construct a full TPP report based on the current, approved version of each TPP element.
Building your Quality Target Product Profile....
The Quality Target Product Profile (QTPP) is a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account patient safety and efficacy (see ICH Q8(R2)). The QTPP describes the design criteria for the product based on product quality attributes. Use QbDVision to:
Define your product quality attributes including acceptance criteria.
Link them directly to your TPP elements to establish the first layer of requirements traceability.
Use risk our filtering tools to determine which attributes are critical to patient safety and efficacy
Define risk mitigation studies and establish a control strategy based on residual risk
Final Quality Attributes (FQAs), and should therefore form the basis for the development and risk assessment of product quality attributes and manufacturing process variables including material attributes and process parameters.
....Developing your manufacturing process
Once your TPP and QTPP are defined and linked, you can begin to layout your manufacturing process in QbDVision. Add the API and excipients and identify material attributes which you can link to final quality attributes outlined in your QTPP. Next, add unit operations and all the equipment, parts, and disposables used in the manufacturing process. Your unit operations likely have their own quality attributes for the intermediates produced at each step. In QbDVision you can define these and link them to the final quality attributes. For each component in your unit operation, you can identify material attributes and process parameters and link them to the intermediate quality attributes. Through this process, you build the next layers of traceability to track how your manufacturing process affects final product quality.
Assessing the risks....
One of the key elements of the quality-by-design approach is iterative risk assessment. As you move through the evolution of your manufacturing process development from pilot scale to registration scale to commercial scale, risk assessment of the critical process variables and their impact on critical quality attributes at each stage is required. QbDVision simplifies your risk assessment activities by allowing you to set the impact and uncertainty (or severity and probability) levels for each defined attribute and parameter. Not only can these be defined numerically, you can also attach documents or other supporting information to provide data-driven justification. As your manufacturing process grows in scale, these risk settings can be revisited and adjusted creating a history of the risks and the control strategies use to mitigate them.
....Visualizing your process over time
Even a relatively straightforward manufacturing process can produce a hundred or more variables to track over many years producing large data sets. The old approaches of using Excel tables with document management systems are increasingly dysfunctional. QbDVision moves away from these old paradigms providing novel visualization tools to view large sets of data. Take, for example, the risk map report which provides a composite view of the risks defined in your manufacturing process. Using knowledge graph technology, QbDVision shows you all the variables in one map, how they link to quality attributes, and color-coded by risk level. Even better, a history timeline shows you how the map has changed over time. It is a powerful tool and one of many to demonstrate how your process has evolved into a controlled, validated state.