Quality Risk Management: Putting GMP Controls First.

Area of Science:

• Pharmaceutical Manufacturing
• Quality Risk Management
• Regulatory Compliance

Background:

• Manufacturing processes require validation, and equipment needs qualification to ensure medicine quality and safety.
• Current quality risk management (QRM) approaches may lack scientific rigor, leading to subjectivity in risk assessments.
• Effective management of risks is crucial for proposed changes in manufacturing processes and equipment.

Purpose of the Study:

• To present a practical, science-based approach for improving quality risk management (QRM) in pharmaceutical manufacturing.
• To enhance the integration of QRM with qualification, validation, and change control processes.
• To address the scientific evaluation and classification of good manufacturing practice (GMP) controls within QRM.

Main Methods:

• Evaluating and classifying good manufacturing practice (GMP) controls based on their impact on risk assessment parameters (severity, occurrence, detection).
• Developing a QRM process that directly links risk assessment outputs to qualification and validation protocols.
• Focusing on the detectability of risks, emphasizing assurance in manufacturing processes over sole reliance on detection controls.

Main Results:

• A refined QRM methodology that scientifically supports qualification, validation, and change control.
• Improved classification of GMP controls within risk assessments, reducing subjectivity.
• Enhanced assurance in manufacturing processes by critically evaluating reliance on detection controls.

Conclusions:

• The proposed QRM approach offers a more scientific and practical framework for pharmaceutical manufacturing.
• Integrating GMP controls into QRM strengthens validation, qualification, and change management.
• This methodology reduces uncertainty and enhances the reliability of medicine production.