18/19 February 2020
A draft of Ph Eur. chapter 3.2.3. Sterile plastic containers for human blood and blood components has been published for comments in Pharmeuropa 29.2. Deadline for comments is June 30, 2017.
It is proposed to delete the abnormal toxicity test (2.6.9) (ATT) from the Tests section. EDQM says that "The relevance of this test was reviewed in depth during an EPAA International Workshop (‘Modern science for better quality control of medicinal products: Towards global harmonisation of 3Rs in biologicals’) in September 2015. The test was considered to be outdated and it was shown to be neither specific, reproducible, reliable nor suitable for the intended purpose. Additionally, with the introduction of improved GMP controls and application of adequate and stringent QC measures it has become unnecessary. It was concluded that the ATT lacked scientific relevance and its omission would not compromise the safety of biologicals. The proposal is also in alignment with the 3Rs principles relating to the use of animals in testing and the need for scientific justification."
As reported in Ph. Eur. Drafts on Rubber Closures (3.2.9) and Plastic Containers for Blood (3.2.3) a draft of chapter 3.2.3. has been previously published in Pharmeuropa 28.3 (Deadline for comments was September 30, 2016). The revision proposed for this general chapter included, amongst others, the replacement of water for injections R by water R, deletion of pyrogens test (2.6.8) and the revision of Packaging and Labelling sections. At the time of publication of the current text in Pharmeuropa 29.2, it is not yet known whether the previous proposed amendements have been accepted. Therefore, EDQM points out that readers are now invited to comment only on the revised parts concerning deletion of the abnormal toxicity test (2.6.9).
Following your registration on the Pharmeuropa website you can read the complete draft chapter 3.2.3. Sterile plastic containers for human blood and blood components.