Thursday, 17 February 2022 9 .00 - 16.30 h
The long-awaited new monograph <1790> of the US Pharmacopoeia about the visual inspection of injections finally came into force on August, 1st. Chapter <1790> with its number >1,000 is not mandatory; it's considered to be an explanatory text for the already published chapter <790> "Visible Particulates in Injections", which is mandatory in the US.
Chapter <1790> had first been published in the Pharmacopeial Forum PF 41(1). Shorty after that, a revised version was published in PF 41(6). That was in 2015 and ever since then, little has been heard about the new chapter. With the entry into force of USP 40 NF 35, it finally came into effect on August, 1st 2017. The final version is not 100% identical to the one which had been published in PF 41 (6); there were substantial changes in some explanations.
One of the reasons for the gap between initial publication and entry into force were discussions with the authorities on the AQL concept. The USP had introduced it in chapter <790> and elaborated on it in the draft for chapter <1790>. Even though the AQL concept allows to make the vague requirement "practically free from particles" statistically comprehensible, there is a fear of GMP obligations being neglected if a batch meets the AQL requirements in spite of anomalies. In case of anomalies on the market, for example, it should not be sufficient to perform AQL tests on the retain samples and - if that were successful - not to start further investigation of the defect found on the market.
There is no comparable approach in the European Pharmacopoeia so far, and no signs of that changing in the foreseeable future. On the other hand, performing the AQL test (or something comparable) is already state-of-art also for European pharmaceutical companies.