The FDA has issued a recall for 5 batches of ranitidine tablets due to raw material contamination with a Pseudomonas species. This shows that recalls can still be required for microbial contamination of non-sterile dosage forms. A good chance to review the likely sources of Pseudomonas within a solid dosage form. Purified water? Tablet coating? Is Pseudomonas an objectionable organism for oral preparations according to the BP?
Process Validation Guidelines from Asia
Draft PV guidelines have been published within the Asian area which are largely based on the FDA and EMA guidance already in circulation.
Inhaled Insulin
Phase 3 studies have shown some promising results for insulin delivery via the inhaled route. A good time to review the pros and cons of s/c protein suspensions vs powder protein for inhalation with regards stability, manufacturing, patient concordance etc
Risk of CJD found in medical devices
A report from the USA that describes patients put at risk from contaminated medical devices infecting patients with CJD. It is interesting to note that the sterilisation process utilised within the hospitals were incapable of killing the prions responsible and that there is no diagnostic test for CJD.
GSK's long term plan for China
Following on from GSK's bribery case in China the pharmaceutical giant is said to be contemplating its future presence within China. There is also rumours that GSK is poised to sell off some of its iconic consumer brands Lucozade and Ribena to focus on its core pharmaceutical business.
Sterile compounder recall
Yet another recall issued from a US steriles compounder due to questions over contract sterility testing methods.
Free Webcast - containment strategies in high-potency manufacture
The cost of Drug Development
An interesting article where NICE is questioning Pfizer's estimate of the cost of bringing a drug to the market. The quote from the NICE chief exec sums it up nicely:
“if it really does cost £1.2 billion to develop a new drug, the
question the pharmaceutical industry must be able to answer is this: are
you absolutely confident that it needs to?”
will QbD bring about a reduction in these costs?
Spanish Pharmacy Debt
Bail outs are often associated with the financial sector so this article came as a surprise to me. As a potential QP releasing product to Spain you should be aware of these policies as it may affect your market. If pharmacies do close down will there be an increase in demand? Will this increase lead to counterfeit risk? Will patients turn to the internet? Will this manifest as a change in your PV complaints from this market?
Hospira Recall
Hospira has issued a recall of Aminosyn II sterile infusion due to the presence of a human hair within the product. This should make you question the gowning requirements for aseptic filling. How would you tackle this as a potential scenario?
New Herceptin Formulation
Roche has received approval for a sub-cutaneous version of Herceptin. This will help offset the risk of patent expiry of the IV formulation for a few more years. A good time to review the administration risks of SC vs IV. It is also worth considering how the IV version is actually administered to patients. Read section 6.6 of the SPC and see for yourself! Hopefully the SC formulation will be easier to administer.
QP as leaders
A great article examining the role of leaders within the ever changing world of biotechnology. QPs should be leaders and 'change agents' not only within the quality department but throughout the entire organisation. These soft skills are an essential element to your QP training.
Happy Reading!
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