by Steve Todd, Senior GDP Inspector, MHRA

Quality Risk Assessment is defined as, systematic process of organizing information to support a decision within a risk management process.

Identification of hazards, analysis and evaluation of risks are part of Quality Risk Management.

Quality Risk Management is not new, and is part of the EU GDP guide.

ICHQ9 spells out Quality Risk Management as not only a systematic process for assessment and control, but also for communication and review of risks to the drug product across its life cycle.

Risk communication promotes a “culture of risk awareness.”

According to ICHQ9, Quality Risk Management should ensure risk evaluation based on scientific knowledge, experience with the process and links to patient protection.

The EU GDP Guide emphasizes a risk-based quality system with the appropriate CAPA corrections and that returned products for example, must be handled according to a written risk-based process, taking into account the product concerned, the stated specific storage requirements and time elapsed since product dispatch to the customer.

The EU GDP Guide also covers equipment qualification and validation, transport modes and accompanying documentation that demonstrates that the product has not been exposed to conditions that could compromise quality and integrity.

“Risk assessment does not need to be a complicated process and should be appropriate to your company,” suggested Steve Todd, who also covered risk assessment tools such as spread sheets.

He also mentioned the importance of Critical Control Points (CCP) and tools, such as diagrams and flowcharts to assist in successful Quality Risk Management.

View the slides from this session here .