FDA Expectations concerning Real Time Release Testing (RTRT)

In one of our previous news we have discussed the European requirements concerning Real Time Release Testing (RTRT). RTRT is defined as the ability to evaluate and ensure the quality of products based on process data.

The FDA also has published an interesting presentation on its website entitled "Regulatory Perspective on Real Time Release Testing (RTRT)" by Dr. Christine Moore, CDER, FDA.

When RTRT is used, it is part of the control strategy and can include some or all of the final critical quality attributes (CQAs).

The presentation includes considerations concerning the point of testing, sampling methods and the RTRT specification. Regarding the batch release decision for RTRT, the presentation states that end product testing should not be substituted for failure of an RTRT release method. The failure should then be investigated first.

Further key topics of the presentation are the different models used in RTRT: 

  • Calibration models (for NIR, Raman, FTIR, such as chemometric analysis), 
  • Surrogate models for time-consuming measurements, 
  • Design space models, 
  • Process control models (such as statistical process control), 
  • and other models.

As concerns the authorisation of RTRT, the level of detail in submission should depend on the importance of the chosen model to the overall control strategy. In the case of low impact models a general discussion of the model is sufficient, whereas in the case of high impact models (e.g., RTRT models) a full description of data collection, pretreatment and analysis is needed.

The FDA explicitly supports the implementation of RTRT.

Real Time Release Testing is one of the key topics addressed at the University of Heidelberg QbD/PAT Conference on 26 and 27 September 2012. More specifically, the following topics will be discussed:

  • Real Time Release Testing from an EU regulatory perspective, 
  • The challenges of large sample sizes for batch release decisions, 
  • Analytical methods that can be used for RTRT applications, 
  • Case study of an RTRT method - from authorisation to worldwide realisation.

Please also see the complete FDA presentation "Regulatory Perspective on Real Time Release Testing (RTRT)" for further information.

Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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