Friday's Round Up

API Importation Flow Chart

A good overview of the written confirmation requirements of API imports and a useful flowchart which outlines the process

CEP Update

The EDQM has updated the CEP certificate with regards to the listing of manufacturing sites.  From the 15th July the CEP certificate will carry details of all manufacturing sites involved in the manufacture of the API.  This includes sites performing packaging, micronisation, sterilisation & QC. 

Diovan Data Fabrication
Genentech Data Issues

Yet more reports of falsified data relating to drug development.  Repeated reports should be making you think of potential viva scenario questions relating to this and how you would tackle it.

Certificates of Medicinal Products

I came across the term CMPs for the first time this weeks.  CMPs are issued by the EMA to confirm the marketing authorisation status and the GMP status of the manufacturing site.   The appear to be primarily used for export to 3rd countries to support regulatory approval within that 3rd country.

Supplement Recall (FDA)

A recall for supplements containing medicinal active ingredient sildenafil.  A good example of how API supply chains are being compromised but will the FMD prevent this from happening in the UK?

Orphan Updates

Orphan drugs are rarely out of the news.  The EMA has updated its guidance on orphan applications and sponsorship transfer.  This document provides a good overview of the expectations of the EMA for orphan applications. 

Insects in vials (FDA 483)

More issues highlighted by the FDA relating to an Indian & New York CMO.  Insects within vials is certainly something I haven't come across before.  When you read about deficiency reports such as this it is good to get into the habit for thinking through your response if this was a potential QP scenario. 

FDA guidance on Technical Agreements

The FDA provide a good guideline on the requirements of TAs and scenarios where TAs have been deficient.

Lucentis & Avastin Equal in Efficacy

A study by the UK government to determine if these two treatments are equally effective for macular degeneration.  This is likely to further the debate between the NHS & pharma  where use of a drug off-label (Avastin) instead of the approval licensed product (Lucentis) has been justified on cost despite questions over the legality of this approach.

Happy reading!