Friday's Round Up

Counterfeit Viagra & Cialis seizure

A large seizure of these popular lifestyle drugs has been reported in the Czech Republic.  It is not clear how the counterfeit products were identified.  It makes you wonder if any have actually gone through the system and ended up in the legitimate supply chain.

FDA Flu Vaccines

A good brief overview of the process of influenza vaccine production by the FDA.  Interestingly the article states that the FDA actually release the vaccines into the US market.  This mirrors some of the UK animal vaccine products that are released to market by the VMD and not the QP (although each batch does require QP certification prior to VMD release).

UK Class 2 recall

A recall of buprenorphine tablets due to a potential printing error with the carton supplier.  This is a good example of when carton suppliers print the batch number as opposed to printing on-line in the high speed packaging lines.  It is also a good opportunity to review the on line packaging controls that may have prevented this error.  I'm guess that a blob detector was used to detect the presence of ink within the space for the batch number.  A more complex optical character verification system may have prevented this error.

Poland's human tissue legislation not good enough

The EC has taken Poland to court as their transposition of EU directives surrounding the quality & safety of human tissues.  I wonder where this leaves the QP's responsibility?  If for example a UK IMP QP was certifying ATMPs manufactured in Poland.....

ATMPs on the radar

Only the 3rd ATMP application to the CAT and the 1st to include non-clinical data and eludes to more ATMP applications on the horizon.  It is worth mentioning that a new MIA has established as part of ATMP manufacturing in a hospital setting.  The MIA is termed 'MeAT'

FDA recall (Budesonide)

More sterility assurance issues with compounders in the States.  This time a bottle of budesonide has been contaminated with fungal spores.

Medical Device Safety

The EC has introduced more measures to improve the safety of medical devices.  This appears to focus the attention on the oversight of the Notifying Bodies.  Yet more work for the MHRA.......



Happy Reading!