IKSA-GMP

Risk management

Risk management has become an important element in GMP. With the publication of ICHQ9 in November 2005 and its subsequent adoption as Annex 20 in the EU Guide to GMP and more latterly, as Part III to the EU GMP Guide, it is now embedded within the requirements of a pharmaceutical Quality Management System (ICHQ10).

Although the expectations contained within ICHQ9 are still said to be optional, the need to identify, and mitigate risks are clearly not, however this is achieved.

IKSA can provide extensive services associated with the implementation of a Risk Management System including:

• Establishing a company approach to Risk Management
• Defining risk based approaches to GMP decision making
• Executing specific FMEA/HACCP type process risk assessments
• Developing appropriate risk mitigation strategies
• Root cause and impact analysis
• Risk assessment training and coaching
• Risk based inspection and auditing