More Indian woes for Ranbaxy
The FDA have issued an import alert on another Ranbaxy site within India.
Modified Release Technologies
A good overview of the methods for modifying the release characteristics of APIs and how PAT can be used to control the manufacture of these complex formulations.
Generic Xeloda
Teva has received FDA approval for generic capecitabine. This drug is a good example of a pro-drug whereby the drug is converted into 5-FU only in the presence of specific enzymes overexpressed in specific tumours. Oral oncology treatments are enabling more patients to be treated at home and enables cancer to be viewed more as a chronic disease state.
Risperdal Consta Recall
J&J have issued a recall of one batch due to the presence of a mould within vials during QC testing. This suspension of microspheres is administered IM to provide sustained release of active over 14 days for schizophrenic treatment.
Clinical trial data
An interesting report from the Guardian that discuses the publication of all clinical trial data following a parliamentary report.
More UK manufacturing investment
More good news for UK Pharma.
US compounding legislation
US Congress have release draft legislation for the control over pharmaceutical compounding following the NECC disaster in 2012. The proposed text makes for some interesting reading. It makes me wonder if this may eventually impact the compounding activities in the UK.
10 Rules of GMP
Tim Sandle's 10 rules of GMP for use as a training aid.
Bydureon Recall
A recall of one batch of Bydureon due to underfilled vials. This highlighted the fact that my
knowledge of final volume checking within high speed filling lines is lacking. I would guess this can be performed on 100% of vials via checkweighers, automatic particulate camera detectors and/or visible inspection.....I'd better look this up
New Arrival
Baby Sean arrived this week and has added a new challenge to QP studying!
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