Friday's Round Up

Locals Laws & the QP

Industry responses to the draft annex 16 suggest that the requirement for QPs to know all the local laws in all markets is unrealistic.  That maybe so but the QP legal duties defined in 2001/83/EC are pretty clear....

Drug Alert - Sodium Bicarbonate

BBraun has issued a class 4 drug alert for a number of batches of sodium bicarbonate due to the presence of precipitation within retained samples.  This appears to be caused by defect in the rubber stoppers.  A great example of how changes to primary containers/closures can have a significant effect on product quality that may not manifest itself for a number of years (batch was distributed March 2012).  Another interesting point is the statement explaining that a recall is not an option at this time due to the potential of product shortage within the market.  It will be interesting to see if these batches will be recalled at a later date once additional supply has been introduced into the market.

Rapid Drug Quality testing

An article describing an innovative technology that can be used to test for active ingredient concentrations within finished products.  This technology is being targeted for use by clinicians to help in the fight against counterfeit medicines.

ICH steering committee

Details from November's ICH steering committee. 

EMA offers greater orphan incentives

Orphan drugs are rarely out of the news but despite the huge increase in orphan development and huge returns for those companies developing them, the EMA is applying even more incentives for orphan drugs.

Drug shortages causing patient harm

An interesting article describing how drug shortages within the UK is having a direct effect on patient health.  Something to ponder during your viva scenarios when deciding whether to recall or not.


Micro OOS webinar

A free on-demand webinar (once your details are submitted) on managing out of specification investigations originating from the micro lab. 



Happy Reading!