Table of Contents

Overview

The Quality Target Product Profile (QTTP) is a detailed outline of a drug product's intended quality. It includes:

• Critical Quality Attributes (CQAs): Properties that must be within specific limits to ensure the product's desired quality.

• Final Quality Attributes (FQAs): The ultimate quality characteristics the product must possess.

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Key Concepts

When you open the product tab in QbDVision, the system defaults to the QTTP. Included in the QTTP are three types of attributes. When adding a Quality Attribute or a Performance Attribute, there are sections to capture details about the attribute itself: criticality assessment, acceptance criteria, process capability, and risk control.

General Attribute

 A General Attribute refers to characteristics of a Drug Product (DP) or Drug Substance (DS) such as dosage form, intended use, route of administration, or packaging. These attributes help define the overall identity and purpose of the pharmaceutical product.

Quality Attribute

A Quality Attribute refers to a specific physical, chemical, biological, or microbiological characteristic that should be within the specified range or distribution to ensure the desired product quality.. Quality attributes can be classified as Critical Quality Attributes (CQAs) if they are essential for product quality and performance or as Final Quality Attributes (FQAs) if they are used to confirm the quality of the final product.

• Final Quality Attribute (FQA): a property or measure of the final product that is indicative of the overall quality of the process relative to the batch or release.

• Critical Quality Attribute (CQA): An FQA that is risk assessed to be critical to product quality. A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality (ICH Q8). Examples include enzyme activity, host cell protein, bioburden, or moisture content.

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Acceptance Criteria for a Quality Attribute

Acceptance criteria are specific standards or requirements that must be met in order to ensure the quality or performance of a product or process. When it comes to quality attributes (such as FQA or CQA), acceptance criteria are typically based on regulatory guidelines, industry standards, or internal specifications. These criteria are crucial in determining whether a product meets the desired quality standards. For example, for a pharmaceutical product, acceptance criteria for a quality attribute like purity may specify a maximum allowable level of impurities

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Risk in Quality Attributes

Product risk for a Quality Attribute refers to the assessment of the potential risks associated with a specific Quality Attribute of a product during the manufacturing process. This assessment helps identify and prioritize critical Quality Attributes (CQAs) that may impact the safety, efficacy, or quality of the final product.

QbDVision enables users to systematically evaluate and manage product risks related to Quality Attributes, considering factors such as the attribute's impact on product performance, patient safety, regulatory compliance, and overall product quality. Users can define risk levels, likelihood of occurrence, and consequences of failure for each Quality Attribute, which helps determine the criticality of the attribute in the overall manufacturing process.

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Performance Attribute

A Performance Attribute refers to a specific characteristic or property of a product that relates to its functionality, effectiveness, or behavior under certain conditions. Performance attributes are crucial for evaluating a product's ability to perform its intended function or deliver the desired therapeutic effect. They are also crucial for ensuring the product's efficacy, safety, and overall performance.

• Final Performance Attribute (FPA): a property or measure of the final product that is indicative of the overall performance of the process relative to the batch or release. Examples include yield or total protein titer.

• Intermediate Performance Attribute (IPA): a property or measure of an intermediate step in the manufacturing process that is indicative of the overall performance of the process relative to the batch or release. Examples include step yield, total cell density (TCD), viable cell density (VCD), viability, or productivity.

Acceptance Criteria for a Performance Attribute

Acceptance criteria for performance attributes (such as FPA or IPA) are focused on the functionality or performance of a product or process. These criteria are often related to the efficiency, effectiveness, or reliability of the product. For example, acceptance criteria for a performance attribute, such as dissolution rate, may specify the minimum percentage of the active ingredient that must dissolve within a certain time frame.

Risk in Performance Attributes

The concept of risk for a performance attribute involves assessing and managing the potential risks associated with a product's performance characteristics during the manufacturing process. This assessment helps identify critical performance attributes (CPAs or IPAs) that could impact the effectiveness, efficiency, or reliability of the final product.

Frequently Asked Questions

What’s the difference between the TPP and the General Attributes section of the QTPP?

The TPP sets the goals for the drug product, while the General Attributes define the measurable characteristics that ensure these goals are met.