Friday's Round Up

Teva UK Warfarin Recall

A class 3 recall was issued this week following ongoing stability issues surrounding degradation products for Teva UK's warfarin tablets.  Interestingly only the 3mg tablets are affected and not the 0.5mg, 1mg or 5mg tablets.  For all you non-pharmacists it is worth learning about warfarin as it is a somewhat unique drug in terms of its ongoing patient monitoring, side effects and drug-drug & food-drug interactions.

Now that's what I call a recall (FDA)

Probably the largest multi product recall I have ever come across.  This recall is from a USA Pharmacy drug compounder and the FDA has obviously uncovered some serious failures in their sterility assurance.  This echoes the previous case of the NECC from earlier this year. 

Benztropine Recall (FDA)

Visible particulate matter within the vial is the reason behind this recall.  The FDA provides a useful overview of the risks of injecting particulate matter into the body.

Cold Chain Presentation by Ian Holloway 

This presentation covers the cold chain distribution, deviation management, use of MKT, calibration certificates & investigation practice.  A very useful 30 minutes and will provide a great deal of information surrounding potential scenario questions on temperature deviations within the supply chain.
NB: This link will require registration with the website to watch the full length video.  There is no confirmation email so any email can be stated on the registration form.

Cosmetic GMP Guidelines

The FDA has published draft guidelines for GMP for cosmetic products.

Update to CEP guidelines

This follows on from last week's update surrounding the changes to the format of the CEP to include all manufacturers.  The guidance document provides a good overview of the requirements for informing the EDQM of revisions/renewals to the CEP.

Hitting 2 birds with 1 stone

An interesting article highlighting Genentech's progress in their research division.

Webinar - QC testing of Culture Media

A webinar on the use of control strains in the QC testing of culture media.  14th August 2013 @ 4pm (BST)

Medical Device Application process

A nice diagrammatic representation of the process of the medical device approval process.  Medical devices are a relatively hot topic lately as the EU has issued proposals to tighten up the regulatory oversight of medical devices following the PIP scandal.  Further information on these changes can be found here

Danish Regulatory API confirmation Q&As

Another competent authority's take on the written confirmation requirements for API importation.

Death Row & the FDA

A very interesting article surround the FDA's earlier decision to import unlicensed thiopental into the USA to alleviate drug shortages.  This has been successfully challenged by a number of death row inmates. 

Acetaminophen & risk of skin disorders

The FDA has issued a warning regarding the potential for Steven's Johnson syndrome with acetaminophen use.  This drug is known as paracetamol within the UK and in my previous life as a pharmacist I have never encountered this effect.  I've added this alert to highlight the need to be aware of PV issues surrounding products that are well established on the market. 

Happy Reading!