Metrology and USP dissolution

In studies cited in this commentary (6-15, 20) and in various internal and external discussions with its Expert Committee members, stakeholders, and others, USP has determined that a PVT performed at periodic intervals, in addition to mechanical calibration, is required to ensure the integrity and reliability of the dissolution procedure when referenced in the USP performance test and in private regulatory drug product specifications. USP believes that additional work is needed to improve its General Chapters that function to ensure the consistency of drug products and expand them to products other than nonsolution orally administered dosage forms. USP also is in accord with an often stated view that new approaches to assess drug product performance in vitro are needed. In the long term, USP envisions an evolved set of approaches to assess drug product performance for all non-solution dosage forms over time following regulatory approval. Although the use of a PVT with some kind of physical article will be needed in the short term, these newer approaches could offer better public health protection and ease of use by pharmaceutical manufacturers. It is important not to abandon current approaches that have worked well before new opportunities become available. USP hopes that this work can advance jointly with FDA, industry, and other stakeholders.