Category: ICH Guidelines

Quality Risk Management (QRM)- ICH Q9

Quality Risk Management (QRM) is a systematic, science-based approach to identifying, assessing, controlling, communicating, and reviewing risks to product quality throughout its lifecycle. The goal is to ensure product safety and quality.

Key components of the QRM process

• Risk Assessment:This involves identifying potential hazards and analyzing their severity, likelihood, and detectability. It establishes the level of risk to determine where to focus efforts.
• Risk Control:This phase focuses on risk reduction plans, including implementing measures to mitigate or eliminate identified risks. After implementing controls, the remaining risk is evaluated to ensure it is at an acceptable level.
• Risk Communication:This is a crucial and on-going process that involves clearly communicating identified risks and control strategies to all relevant stakeholders.
• Risk Review:This involves a regular review of the quality risk management process to ensure the effectiveness of the controls and that risks remain at an acceptable level. New knowledge and experience are incorporated into this review.

Benefits of Quality Risk Management

• Ensures product quality and safety:By proactively addressing risks, QRM minimizes defects and helps protect the safety of consumers.
• Supports regulatory compliance:QRM is a vital tool for meeting and maintaining compliance with regulatory guidelines from agencies like the FDA and EMA.
• Optimizes resources:It helps focus efforts on areas with the highest risk, which can lead to more efficient use of resources.
• Improves decision-making:It promotes a data-driven approach to decision-making, based on scientific knowledge and evidence.
• Reduces costs:Minimizing quality failures can lead to lower costs associated with recalls, reworks, and other quality-related issues.

Quality by Design (QbD)

Quality by Design (QbD) is a systematic approach to product development that builds quality in from the start by focusing on a deep understanding of the product and its manufacturing process. It uses a science-based, risk-management approach to identify critical quality attributes (CQAs) and critical process parameters (CPPs), establishing a “design space” and control strategy to consistently meet quality targets throughout the product lifecycle.

Key principles and steps :-        

• Start with the end in mind:Define clear objectives and a Quality Target Product Profile (QTPP), which outlines the desired characteristics of the final product.
• Identify critical quality attributes (CQAs):Determine the measurable characteristics of the product that are essential for its performance and safety.
• Identify and understand critical process parameters (CPPs):Identify the variables in the manufacturing process that have the most significant impact on the CQAs. This is done through experimentation, risk assessment, and statistical analysis.
• Establish a design space:Define a multi-dimensional combination of input variables and process parameters that have been demonstrated to provide assurance of quality. This is the “safe operating zone” for manufacturing.
• Develop a control strategy:Implement a plan to manage the CPPs within the design space to ensure that the product consistently meets its quality attributes.
• Continuously improve:Use the understanding gained to support continuous improvement and innovation over the product’s lifecycle.