ICH Q9 guidelines - Quality Risk Management( Important features of ICH Q9)

 ICH Q9 guidelines are known as Quality Risk Management issued by International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. This guidelines gives description on how the Quality Risk Management can be applied to uphold the quality of medicines in Pharmaceutical Industry. This guideline also covers development, Manufacturing and Distribution including whole life cycle of medicinal products. Quality Risk Management can be defined as a systematic assessment of risks and a approach to control and communicate such risk to enhance Quality of product.

Principle of Quality Risk Management:

The principle includes Evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient and the level of effort, formality and documentation of the quality risk management process should be in correspondence with the level of risk.

Process of Quality Risk Management: The Quality Risk Management follows below steps:

1.Initiate Quality Risk Management Process

2.Risk Identification, Analysis and Risk Evaluation.

3.Risk Reduction and Acceptance

4.Review Event

Risk Management Methodology:

Quality risk management supports a scientific and practical approach to decision-making.  It provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity and sometimes detect ability of the risk.

1.  Basic risk management facilitation methods (flowcharts, check sheets etc.); 
2.  Failure Mode Effects Analysis (FMEA); 
3.  Failure Mode, Effects and Criticality Analysis (FMECA); 
4.  Fault Tree Analysis (FTA); 
5.  Hazard Analysis and Critical Control Points (HACCP); 
6. Hazard Operability Analysis (HAZOP); 
7. Preliminary Hazard Analysis (PHA); 
8. Risk ranking and filtering; 
9. Supporting statistical tools.