Last week’s round-up, 07 – 11 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud

 

ICH Reverts to Previous Version of Guideline on Residual Solvents

11 Oct 2019

The ICH has reverted to its previous version of the guideline on residual solvents.

This change affects the Permissible Daily Exposure (PDE) for ethylene glycol. In October 2018, an error correction procedure was launched to change the PDE listed for this solvent, due to notification by an external party of a discrepancy between the value listed in the guideline and that in the monograph for ethylene glycol. However, based on archival documents and a review of the literature, the PDE of ethylene glycol has now been reinstated to its pre-2018 value of 6.2mg/day. The originally noted discrepancy arose from a reassessment of toxicity data which was incorporated in the residual solvent guideline but not in the solvent’s monograph.

Included in the guideline’s next update will be PDE levels for three additional solvents,  2-methyltetrahydrofuran, cyclopentylmethylether and tert-butanol: http://bit.ly/RealGenerics-328ZZ1B

 

EMA Staff Losses Tick Up as Workload Increases

10 Oct 2019

The EMA has lost 20% of the staff it had in London and the agency has announced that it will be challenging to deliver the EMA’s work programme for the last quarter of 2019.

Staff has reduced by a further 6% from the last related update in June. At the same time, the number of new initial evaluation applications for human medicines has increased by 34% compared to the same time period last year. EMA executive director, Guido Rasi, has said that the agency is reviewing its structure and plans to set up task forces for key priorities, including digital business transformation, regulatory science and innovation, and data analytics and methods: http://bit.ly/RealGenerics-313nwQ0

 

Container Closure Integrity Testing of Finished Sterile Injectable Product

09 Oct 2019

Container Closure Integrity (CCI) is critical for the maintenance of sterility and stability of finished sterile products, and new regulatory guidance in this area has triggered changes in industry best practices.

With this in mind, the following article summarises the current state of CCI testing in both the pharmaceutical and biopharmaceutical industries and outlines CCI testing strategy approaches. Best practices include the generation of science-based CCI data throughout the product lifecycle to build a profile database and the use of deterministic CCI tests methods that have been validated to detect a critical leak. A toolbox of CCI testing technologies should also be used that can be optimized on a per-product package configuration: http://bit.ly/RealGenerics-35niGR5

 

Problems With Ranitidine May Transcend Manufacturing Issues

08 Oct 2019

Recalls of ranitidine products continue after tests revealed the presence of the carcinogenic impurity N-nitrosodimethylamine (NDMA).  Ranitidine has been widely prescribed for 30 years.

FDA is now recommending that lab testing should be performed at a lower temperature than that used to test for NDMA in sartans, as it has been shown that at high temperatures ranitidine reacts with itself to form NDMA.

Research by Stanford researchers and by Connecticut-based online Pharmacy Valisure also suggests that ranitidine is inherently unstable and can release NDMA within the human body.

For further details please see: http://bit.ly/RealGenerics-2LYGnYy

 

Image: Laboratory Experiment; CC BY 2.0

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