Difficult-to-make drugs meet US quality standards

Generics/Research | Posted 14/05/2021 post-comment0 Post your comment

Difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the country, finds a study published in JAMA Network Open [1].

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The study authors, based at the US Food and Drug Administration (FDA), set out to uncover if there were any clear and substantive differences in the major quality attributes of difficult-to-make solid oral dosage form pharmaceutical products manufactured globally and marketed in the US.

They carried out a quality improvement study in which FDA collected samples of 252 drug products marketed in the US and manufactured in the US, Canada, Europe, India, and the rest of Asia, were analysed. The drug products selected were immediate-release solid oral dosage forms which are considered ‘difficult-to-make’. The team’s sampling included 35 innovator and 217 generic drugs, containing 17 different active ingredients that were manufactured by 46 different companies. These were investigated through statistical analysis carried out from February to November 2019.

The major quality attributes of dosage unit, uniformity and dissolution of each product was tested via legally recognized tests of the US Pharmacopeia. Such tests measure dosage consistency and drug release, respectively. Following this it was possible to calculate a process performance index to describe variability in manufacturing.

Overall, the team found that all drug product samples tested met the US market standards for dosage unit uniformity and dissolution. This means that all were acceptable for use by patents in the US, regardless of manufacturer or country of origin. However, some differences in the consistency of these attributes among regions and manufacturers were highlighted. For example, when it came to the process performance index and determining the products’ 4-sigma capability – which is a manufacturing performance benchmark, indicating that more than 99.994% of manufacturing process outputs are expected to fall within the specified limits - not all products hit the mark.

In conclusion, the research team highlight that this is the largest such study carried out on US marketed pharmaceuticals. As such, it offers important insight into the quality of difficult-to-make drug products available in the US.

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1. Fisher AC, Viehmann A, Ashtiana M, et al. Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US. JAMA Netw Open. 2020;3(8):e2013920.

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