USP Statement on Dissolution Testing

GMP News No. 887: USP Statement on Dissolution Testing

GMP News
14 February 2007
 

USP Statement on Dissolution Testing

 
Basic requirements on dissolution testing can be found in General Chapter <711> - Dissolution - of the USP. On this General Chapter, the USP published a statement in October 2006.

According to the USP, the suitability of dissolution testing equipment is proven by means of the following two tests

  • USP's Performance Verification Test (formerly termed "Apparatus Suitability Test") with allied reference standard tablets (formerly termed "calibrators") and
  • mechanical calibration
  • Both tests are in conformance with cGMP- and ISO approaches and have to be conducted together. It is not enough to conduct either one or the other.

    The USP has performed studies in order to confirm these statements and to verify the quality of the USP reference standard tablets.

    This statement also deals with the qualification of dissolution testing equipment. For the dissolution procedure, OQ (operational qualification) is conducted through calibration/verification of the mechanical parameters, usually every 6 months. PQ (performance qualification) is done by means of the USP Performance Verification Test, also typically at 6-month intervals.

    Again, the USP emphasises the fact that the USP reference standard tablets are no "calibrators". Therefore, the USP will not use the term "calibrators" for the "reference standard tablets" any longer. Similarly, the name "Apparatus Suitability Test" mentioned in General Chapter <711> does not accurately describe the nature of the test, which is why it is to be replaced by the term "Performance Verification Test".

    What is also interesting is USP's reference to ISO saying that mechanical calibration alone is not sufficient to prove the suitability of dissolution testing equipment. For this reason, the USP does not support the "ASTM-I mechanical calibration standard", which must have been about to reach consensus.

    The complete USP statement can be found here: The USP Performance Test and the Dissolution Procedure Statement
       

    Learn more about the principles and practices of dissolution testing at the 3-day ECA education course

    Dissolution Testing

    in Berlin from 27-29 June 2007.

    One of the focus topics of this course is the qualification of dissolution testing equipment.

     
    Compiled by:
    Dr Günter Brendelberger
    On behalf of the European Compliance Academy (ECA)
      

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