Class 4 Drug Alert - Fentanyl Patches
Takeda have issued a class 4 drug alert for one of their fentanyl transdermal patch preparations due to incorrect packaging details. The details of the drug alert would suggest that this may be escalated to a recall once corrected stock is available.
Class 2 Drug Alert - Tixylix Oral Liquids
Novartis are recalling a number of batches of their Tixylix cough preparations due to a manufacturing fault with the primary container. This echoes the Boots manufacturer's led recall from last week. Why one was deemed a class 2 recall and the other a manufacturer's led recall is unclear to me....
More UK Investment from GSK
More good news for the UK's pharmaceutical manufacturing industry as GSK has announced further investment into their Ware and Worthing sites. Will they need more QPs??
New Local Laws in UK
Following the introduction of new drug driving laws to be implemented shortly, the MHRA has issued a statement requiring MA holders of specific drugs to update their packaging components with new warnings for drug driving. A good example of how QPs need to be aware of updates to local laws - not just GMP updates.....
Deficiencies at API manufacturers
An article detailing the inspector training and common deficiencies identified by PIC/s during inspections of API manufacturers.
QbD for Sterile Manufacturing
QbD has been well described in the non sterile solid dosage form arena over the past few years. This article describes the challenges of implementing QbD in sterile manufacturing processes.
Horizon 2020 Launched
The EC's funding stream was launched this week and follows on from the framework funding programmes (FP7). The EC has made 71 billion Euros available for grants over a 7 year period for a range of scientific disciplines including healthcare.
Happy Reading!
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