This is the first of my weekly round up posts. The aim of these is to provide an overview of any news articles, stories or anecdotes I come across during the week that may be relevant to trainee QPs.
WHO Water Guidelines
These were published last October but only found their way to my updates folder this week. A good overview of water systems for those with limited first-hand experience in them
Ventolin Syrup Recall (MHRA)
A class 2 recall from Glaxo Wellcome due to the potential for glass particle contamination within the syrup. As always the recalls provide a great scenario question to test out your thought process in dealing with the initial complaint/defect.
Vecuronium Bromide Injection Recall (FDA)
Sagent Pharmaceuticals are recalling a number of batches due to an elevated impurity result from routine testing (assuming ongoing stability testing). Again, start thinking of the questions you would need in order to provide more information if presented with this during the viva. For example - confirm the impurity result & with OOS investigation would be one of my first things to clarify......followed closely by identifying the impurity....
Warfarin 2mg recall (FDA)
Zydus Pharmaceuticals is recalling one batch due to oversized tablets. This product is presented in 1000 tablet bottle and is a good example of a dose critical product where both overdose and underdose can have significant clinical consequences.
Cilest Recall
J&J adding to the baby boom! Anyone fancy performing the reconciliation on a recall of 32 million units?!
Ph Eur monograph update proposal for Glass containers for Pharmaceutical Use
From Tim Sandle's excellent site details a proposed update to monograph 3.2.1. regarding control of production of glass containers as well as QC testing for hydrolytic resistance.
Updated EMA Q&A on APIs
A number of questions within this document were updated in May. There are some that are related to the QP such as the regulatory expectation of API audit contents, qualification of API auditors (questions 8, 9 & 10). Useful information for the FMD and round-the-world related viva questions. (Remember - GMP Part II doesn't directly apply to IMPs)
MHRA update on API imports & written confirmation
A post that will probably lead to more work for the QP. This outlines the MHRA's plan for the July deadline for written confirmation of APIs from 3rd countries following FMD requirements.
The interesting section is:
'Where UK Manufacturing Authorisation Holders ("MIA Holder") have determined that their third country AS sources are at risk and have not been contacted by MHRA they should provide evidence in the submission / declaration...'
I think it is safe to assume that 'MIA holder' will be substituted with 'QP'..... !
EMA Q&A document on Israel-EU MRA
Interesting document that covers the product types included and not included. Interestingly GMP certificates issued prior to the MRA implementation date are considered valid
Japan added to EMA's white list for API import
The list of 3rd countries now on the white list is: Australia, Switzerland & Japan. API imports from these countries will not require written confirmation for each batch imported into EU. USA, Israel & Brazil are currently under evaluation.
Happy reading!
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