Friday's Round Up

A busy week for recalls and an important update to Annex 16 has now been published in draft.

Multiple Class 2 Wockhardt Product Recall (MHRA)
Multiple product recalls are rare.  The previous example can be traced back to another Indian manufacturer Ranbaxy.  For the recall not to state specific batch numbers means an endemic problem and I wouldn't fancy being in the Wockhardt QP's shoes this week. More information on this can be found here and here.  It appears to centre on a lack of cleaning and falsification of training documents were the main reasons behind the recall.  

 Erythromycin Class 2 Product Recall (MHRA)
likely to be linked to the Indian CMO implicated in the Wockhardt recall but this has specific batch numbers affected.

50ml Sterile Syringe recall (BD)
MHRA field safety notices for medical devices are often overlooked area for information for trainee QPs.  This recall is for sterile syringes.  This is a recall that may directly affect specials manufacturing, especially those units that manufacture sterile pre-filled syringes commonly used for analgesia.  As the syringe is the primary container knowing that these have been recalled due to a potential for leaks will require the specials unit to recall those syringes as this will pose a risk to sterility assurance.

Annex 16 Draft now Published  

There is more emphasis on supply chain verification and increased scope for routine duties of the QP including a formal assessment of 3rd part audit reports.  QP discretion is highlighted but only if registered specifications are met and formal impact assessment documented.  I presume there will be a period where 2 different lists for routine QP duties are available (annex 16 update & current code of practice) and you’ll need to know both for your upcoming viva.

Mexican API GMP published 

Mexico have published these presumably to be considered for inclusion to the EU white list for API importation.

FDA guidance on Heparin control 

The FDA have recently published this guidance document following the heparin contamination issue during 2008. 

Estarylla Recall (FDA) 

Sandoz helping with the baby boom!  A good example of a lack of segregation control for commercial combination product.  It is worth considering the impact of this type of issue with regards to IMPs and comparing the risks compared with commercial product (eg GCP risk).

Regulatory Tweets  

A comprehensive list of who to follow in the world of global regulatory affairs.

Happy reading!