Friday's Round Up

Rapid Micro ID

BioMerieux has received FDA approval for their Vitek Mass spec system for rapid identification of organisms.  The main advantage of this over the traditional Vitek system is that no culturing or gram staining is required before identification.  Organisms can be taken straight from the agar plate, mixed with a solvent and injected into the mass spec.  Results are compared against a database and usually given within 30mins. 

More US compounding woes

This time the focus is on inadequate sterility testing performed by a contract laboratory.

CEP database

Although this database has been available for some time now, I only discovered this recently so I thought I'd share in case some of you haven't seen it before.  A useful link for checking the CEP status of your relevant APIs.

FDA Inspection Reports

A good overview of the 3 main inspection reports issued during FDA inspections.  Useful information if, like me, you dont have the pleasure of hosting FDA inspections.

Pharmacogenomics Webinar

A free webinar on the use of pharmacogenomic profiling during drug development.  Pharmacogenomics involves the profiling of patients' genetic or proteomic profiles in order to tailor their treatments to those drugs with highest probability of being clinically effective.  This is often associated with the term personalised therapy.

FDA Recall - Glass particles

A recall for daptomycin due to the presence of glass particles in a number of batches.  A useful reminder to review the methods for visible & sub visible particle inspection in final product testing. 

New caps for tylenol

This news article shows how J&J are trying to reduce the risks of overdose with tylenol (aka paracetamol).  I've posted this just to get you thinking about how you would manage this change control as a QP.  Apart from the obvious regulatory variations etc, think about the practical issues such as how to reconcile the old caps from warehousing before bringing in the new caps; how will the cap changeover occur - run down old stock before introducing new caps or full changeover on a single date?

21 CFR 11 overview

A useful overview of the impact of 21 CFR 11 compliance.