Table of Contents

Overview

QbDVision offers a more structured foundation for CMC knowledge management. This methodical approach simplifies the definition, validation, and dissemination of the comprehensive control strategy spanning facilities, materials, processes, and products across the development lifecycle.

A control strategy is a crucial aspect of pharmaceutical manufacturing that outlines how a product will consistently meet its quality attributes. It encompasses identifying critical quality attributes (CQAs), critical process parameters (CPPs), and other factors that ensure product quality and safety.

Key Concepts

ICH Q8 – Domain Relevant Standard

1. Identification of CQAs and CPPs: Users can define the key quality attributes critical for the product's efficacy and safety. These parameters must be controlled within a specified range to ensure product quality.

2. Establishing Acceptance Criteria: The system allows for setting acceptable ranges for each CQA and CPP, ensuring that the product meets the required quality standards.

3. Monitoring and Control: QbDVision enables real-time monitoring of process parameters and product attributes, alerting users to any deviations from the established control limits. This helps maintain product quality and consistency.

4. Risk Management: The platform also supports risk assessment and management by identifying potential risks to product quality and implementing measures to mitigate them.

5. Documentation and Reporting: QbDVision facilitates the documentation of the control strategy, including all relevant information on CQAs, CPPs, control limits, and monitoring procedures. This documentation is essential for regulatory compliance and audits.

A control strategy in QbDVision is vital because it ensures product quality, consistency, and compliance with regulatory requirements throughout the manufacturing process. By defining and implementing a robust control strategy, pharmaceutical companies can minimize variability, reduce the risk of product defects, and ultimately deliver safe and effective products to patients.

Digital Leverage

Open

Traceability with Control Strategy

QbDVision provides a more rational foundation for CMC knowledge management.  This systematic approach facilitates the definition, justification, and communication of the overall control strategy from facilities and materials to process to product over the entire development lifecycle. 

Unit Operation Control Strategy Report

Open

Process Knowledge Maps

Control Strategy Definitions

Release Testing: At the end of the manufacturing process, an attribute is tested. It must meet the specification as a condition of release.

Monitoring (Defined Limits): This parameter has defined limits and is monitored via testing at the end of the manufacturing process.

Monitoring (Report Results): This parameter does not have defined limits but is monitored via testing at the end of the manufacturing process to determine the range of values.

Characterization: A variable requires additional characterization to determine interactions, design space, optimal target, and range, etc.

In-Process Testing: An attribute is tested prior to the end of the manufacturing process. It must meet the specification as a condition of release.

In-Process Control: A variable or attribute that impacts a downstream IQA or FQA.

Not Required: No control strategy is required for this variable or attribute.