An example of a company-led recall as opposed to the recalls issued via the Drug Alert mechanism. Company led recalls do not have a classification to portray the patient risk (eg class 1, 2 etc) and are therefore considered to be generally low risk to patient safety. There appears to be 2 issues with the batches in question. Firstly 2 batches have been released into the UK market incorrectly and secondly the final release testing for dissolution is at the lower end of specification.
Overview of worldwide serialisation deadlines & methods
A nice pdf overview of the different serialisation methods in the pipeline across the world & their proposed implementation deadlines. Worldwide harmonisation on serialisation looks extremely remote!
Annex 16 update webinar
NSF-DBA are hosting a webinar on the changes to the draft annex 16 update on 9th September 2013 @ 16:00 GMT
US supplements with undeclared API
The FDA has issued a recall for sleep supplements containing undeclared doxepin & chlorpromazine. The FDA have issued a number of similar recalls but I cannot remember anything similar arising from the UK via the MHRA. Perhaps this highlights the scope of the FDA's testing programme within the USA.
Self Expiring Packaging
An interesting design to highlight when blister packs expire. I cant see this being particularly important for patients with chronic conditions as blister packs are typically used within a month. This will more likely highlight those old packs of paracetamol at the back of the cupboard for that occasional headache! Once the packaging has expired will it still be in compliance with both the MA and legal requirement for labelling?
Trends in USA Drug Approvals
An interesting overview of the numbers of new drug approvals in the USA between 1987 and 2011. Hopefully the upward trend since 2005 continues and is replicated within the EU?
Counterfeit Drugs in Clinical Trials
A slightly naive post regarding the risk of counterfeit drugs entering clinical trials. Given that comparators are sourced on the open market and pressures to source the cheapest product then this risk is fairly obvious. Although the FMD does not apply directly to IMPs it will apply to comparator products which may reduce this risk if sourced from the EU wholesale distribution network.
Not one to read over dinner
everyday is a school day after all, this was certainly something I'd never heard of before!
Finally.....
An interesting time lapse video of fungi growing on culture media. At around 0.50 you can clearly see sporulation during the growth phase. Certainly not something you want in your product or clean room.
Happy Reading!
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