www.ich.org/LOB/media/MEDIA1957.pdf

The use of Risk management tools from the earliest stages of drug delivery system development should now be a key consideration in any development programme. ISO/FDIS 20072 “Aerosol drug delivery device design verification -- Requirements and test methods”, which PharmaDelivery Solutions Ltd (David Howlett) represented the interests of the British Standards institute on, is founded on a risk based approach to decision making and verification.

PharmaDelivery Solutions Ltd Has been involved in a number of programmes at differing stages and has made contributions in respect of such activities as;

• Preparation of the preliminary Hazards Analysis.
• Development of design Failure Modes and Effects Analysis (dFMEA).
• Review of process Failure Modes and Effects and Criticality Analysis (pFME(C)A).
• Fault Tree Analysis.
• Development of Risk Mitigation strategies and planning.
• Development of Design Verification strategies consistent with the aims of ISO/FDIS 20072.