Friday's Round Up

Overkill Overview

A good article from Pharmaceutical Technology covering the concept of overkill sterilisation cycles for steam sterilising cycles. 

J&J fined for off-label marketing

Yet more woes for J&J and its subsidiaries after the company was fined $2.2 billion for promoting off-label use.  A good reminder of the updated PV requirements of 2010/84/EU stipulating that all off-label & unlicensed use must be incorporated into the PV system.

USP update for particulate inspection

A new draft USP monograph has finally provided a definition for 'essentially free from particles'.  The definition involves a 100% inspection meeting an AQL of 0.65% or tighter for visible particles.  Subvisible particles remain unchanged. 

EMA's Risk Aversion

A very interesting article giving an insight into the EMA's thoughts on risk versus benefit during drug assessments and the potential shift to accept more uncertainty in their assessment.  It is an example of how competent authorities are incorporating ICH Q9 principles into their quality systems.  Some of these concepts may be of use in your decision making process for recall scenarios.

Responses to GMP updates

The EC has published comments from industry following draft updates to the GMP guide, GDP  and  excipient GMP.

Online QP training

Inspired Pharma have recently launched online medicinal chemistry QP training module with more modules scheduled for release over the coming months. 

Ian Hudson Interview

The Pharmaceutical Journal have published an interview with Ian Hudson, the newly appointed chief executive of the MHRA.  The interview highlights the increase in more specialist medicines such as biologicals and the increase in conditional authorisations. 

Compounding for death

US compounders are rarely out of the news and this article raises yet more questions.