Friday's Round Up

Happy New Year!

Class 2 Recall

Teva UK have recalled a batch of methotrexate injection due to reports of damaged vials.  Methotrexate is a good example of a product with multiple indications and possible routes of administration - something you need to consider in your risk assessments

Webcast on metal contamination

Pharmaceutical Technology journal is sponsoring a free webcast on January 22nd covering the methods used to prevent metal contamination within pharmaceutical products.

EMA guidance on IVRS

The EMA has recently published a guidance document on the use of IVRS and their justification for the removal of expiry dates from IMPs.

QP Good Practice Guide

The ECA & QP Association has published a QP good practice guide.  There is an interesting  Q&A session and the end.

Airing your dirty linen

The EudraGMDP website now publishes non-compliance reports for all those naughty sites audited by competent authorities.  Each report gives a good overview of the products affected and a brief overview of the nature of the non-conformance.  A good resource for scenario questions!

PLPI company led recall

A labelling error has led to the recall of a batch of crestor from a PLPI company.  A good reminder of the requirements for PLPI products and the activities they perform.  These tend to be generally smaller scale, manual operations compared to large scale pharma.  I wonder if Astra Zeneca (the reference MA holder) received complaints regarding this affected batch?

Baxter recall - Clinimix

Baxter have recalled a number of batches of clinimax parenteral nutrition products due to particulate contamination.  Part of their risk reduction strategy recommends visible inspection for particles prior to administration and to administer products via an in-line filter incorporated into a giving set. 

Over regulation of Opioids

An interesting article looking at the flip side of regulating the supply of opioids leading to patients going without critical pain relief medications.  This is a good example of the 'local laws' referred to in 2001/83/EC as controlled drug legislation is complex and variable throughout the EU and ROW.

Used Equipment

All you'll ever need to get started in the murky world of counterfeit manufacture.  Do these auction sites perform checks on the bidders?

Drug Donation Programs

An article describing Janssen's donation program for supplying HIV medication in Africa.  My initial thoughts hark back to the issues with 'diverted stock' from a number of years ago and whether this may be repeated. 

Class 4 Drug Alert

Teva has issued a drug alert due to an error in the dose stated within the PIL.

Tamiflu in the News

An interesting discussion on the transparency of clinical trial data with a focus on Roche's product Tamiflu. 


Happy Reading!