Friday's Round Up

GSK continues with UK manufacturing investment

News that GSK is ploughing further investment into its UK manufacturing arms.  After recent investments into their Ulverston site there is a further £23million for expansion of their Montrose facility in Scotland.  Great to see GSK bucking the trend of outsourcing UK manufacturing.

Boot's Pharmaceuticals recall - Oral liquids

A company led recall issued by Boot's via the MHRA website.  Remember these recalls are considered low risk and hence are not disseminated via the Drug Alert system.  The recall is due to potential faulty tamper seals on a range of their liquid formulations.

New Drug Target for Malaria

Novartis has published data on a novel drug target and new class of antimalarial compounds in the journal Nature.  

Baxter recalls Nitroglycerin Injection

Another recall due to potential particulate contamination within a sterile product.  A good reminder to revise the tests used for both visible and subvisible particles in finished products. 

US Congress gives more power to FDA over compounders

Following the fallout from the NECC compounding disaster from 2012, Congress has finally reached an agreement to update the legislative framework overseeing this high risk activity.  The revised bill gives the FDA more power and establishes a voluntary program for compounders to register with the FDA and agree to meet relevant quality standards.

API catalysis

An interesting article describing the advances in the use of catalysts in both chemical and biological API production.  A good prompt to revise the recently published draft ICH guidelines on elemental impurities.

FDA/EMA QbD Q&As

The FDA and EMA have published an update to their joint guidance document on quality by design.

Comments on Annex 16 published

The EC yesterday published comments on the proposed update to Annex 16.

Update to GDP Guidelines

A new version of the GDP guidelines has been published to correct some factual errors and give a formal date of coming into operation (24th November 2013)



 Happy Reading!