Friday's Round Up

 
Counterfeit seizure by MHRA

The MHRA announced the seizure of over £12million worth of counterfeit medicines within the UK this week.  The types of medicines seized included weight loss, hair less and erectile dysfunction.  This operation also involved the closure of nearly 10,000 online pharmacies who were selling counterfeit or unlicensed medicines – will the EU-wide pharmacy symbol following FMD really stop these sites from emerging?


Class 2 recall for HES (MHRA)

All remaining stock of Hydroxyethyl Starch (HES) is being recalled due to results from clinical trials showing increased risk of patient mortality when HES is administered.  HES is given intravenously as a volume expander in critically ill patients following blood loss or trauma.   This is a good example of a recall initiated following ongoing PV rather than the more commonly observed quality defect.

Drug Manufacturing in Space

This interesting article describes how NASA has been investigating the potential for using 3D inkjet printing to manufacture drugs to sustain long space expeditions.  This technology has already shown promise with research from UCL & School of Pharmacy.   Will each space shuttle need an MIA and what legal jurisdiction is space……!!

Teva Packaging error

This error identified packs of furosemide containing zopiclone that was packaged within Teva’s site near Paris.  The article describes the investigation into this and a potential root cause of sabotage.   What would your thoughts be as a QP if you uncovered or suspected this activity within your organisation?

2nd hand medicines?

This article describes a scheme within California that collects unwanted medicines from care homes and re-distributes them to clinics in order to provide assistance to those patients who cannot afford the cost of healthcare in the States.  As a QP do you know the fate of your medicines within the UK?  What happens to patient’s medicines that are returned to pharmacies or hospitals?  

Fraudulent activity at Ranbaxy  

This comes on the back of 2 other reports of companies generating fraudulent data in both USA and Scotland.  Could this be a potential QP viva question?  How would you as a QP tackle this issue if brought to your attention?

Happy Reading!

A Call for Croatian Translators

This week saw the EC advertise for Croatian translators via Twitter.  Now you may be thinking how this relates to a QP training blog?

On the 1st of July this year Croatia will become the 28th member of the European Union.    As a QP you are expected to have a 'comprehensive knowledge of all EU and national legislation relating to the manufacture, storage & supply of medicines...' as defined by the QP study guide.  In order to have this knowledge you first need to know which countries are legally bound to this legislation and which countries are likely to join in the near future.

The EC Europa website gives a useful overview of the status of the EU member states and importantly those countries that are in the process of applying for membership.  In order to get to the first step in the process the country has to meet strict conditions for membership including incorporation of the 35 policy chapters of the EU, including chapter 28 (consumer & health protection) that covers EU legislation on medicines.

Potential countries are grouped into 3 categories depending on their current status.  The first category is for Potential Candidates and are invited to formally begin application proceedings only when they are ready.  As countries progress through their application they then become a Candidate Country and finally an Acceding Country once EU membership terms have been agreed.

Current Status of EU enlargement:

Category	Country
Acceding Country	Croatia (Entry 1st July 2013)
Candidate Countries	Macedonia, Iceland, Montenegro, Serbia, Turkey
Potential Candidates	Albania, Bosnia, Kosovo

Montenegro and Iceland are the 2 candidate countries where negotiations have been ongoing for a number of years.  These countries are the most likely to become acceding countries over the next few years. 

Relevance to the QP viva?

Having knowledge on the countries that are nearing EU membership (particularly the acceding countries) will help in your preparation for the common 'round the world' supply chain questions and scenarios.  These typically involve importation of APIs, intermediates or final products into the EU via a number of 3rd countries. 

Taking Croatia as an example, from 1st July 2013 it goes from a 3rd country to a Member State.  Therefore if you viva is coming up soon there is a high chance that the assessors will include Croatia in their supply chain scenario.  If you fail to recognise that Croatia is a 3rd country before 1st July 2013 then it is highly likely that your answers regarding importation will be incorrect and will obviously not go down well with the assessors. Having an awareness of upcoming additions to the EU shows the assessors that you understand the structure of the EU & have an appreciation of how the continuously evolving landscape within Europe affects your role as a QP.

The table below highlights some factors relevant to QPs regarding the inclusion of Croatia into the EU:

	Croatia (pre 1st July)	Croatia (post 1st July)
Legal Status	3rd Country	Member State
Finished product import Croatia into UK	Testing on import required	No testing on import required
API import Croatia into UK	Written confirmation would have been required	No restriction
QC Testing location	Importation Testing not permitted	Importation testing allowed
Retention Sample	Cannot be stored here	Can be stored here
IMP comparator sourcing	Unlikely to be sourced (equivalent EU GMP to be determined)	Likely to be sourced (EU GMP incorporated into local law)

  

Summary

As I've mentioned previously it's important to maintain up-to-date regarding the relevant legislative & GMP updates in preparation for your viva and throughout your QP career.  I would also recommend to include the structure of the EU (including EEA, EFTA etc) as well as upcoming changes as part of your update strategy leading up to your viva.  Including this RSS feed into your updates folder is highly recommended.