[PDF] GHTF SG3 - QMS - Process Validation Guidance -January 2004

What is GHTF guidance?

The GHTF Guidance is a useful educational tool for understanding how to perform process validation Performing process validation ensure that the process output is predictable and predetermined The completion of appropriate process validation can help reduce waste, reduce cost and reduce the time it takes to get a medical device on to the market.

What is GHTF Study Group 3?

GHTF Study Group 3 - Quality Management Systems Process Validation Guidance – January 2004 Page 12 parameters. When monitoring data on quality characteristics demonstrates a negative trend, the cause should be investigated, corrective action may be taken and revalidation considered.

What is page 15 of 23 of the GHTF risk management guide?

GHTF Study Group 3 SG3/N15R8 Page 15 of 23 Risk Management Guidance Work instructions should also be reviewed and updated to reflect any appropriate risk control measures. 10.2. Work Environment and Personnel

What are the sources of variation in GHTF process validation?

GHTF Study Group 3 - Quality Management Systems Process Validation Guidance– January 2004 Page 23 several sources of variation. For example, variation on a multi-head filler could be the result of shifting of the process average over time, filling head differences and short-term variation within a fill head.