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Risk Management
 
 
The following statement is taken from “International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use (ICH) draft consensus guideline QUALITY RISK MANAGEMENT (Q9)”
 

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.
 
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