Friday's Round Up

2^nd July API Importation: MHRA overview

Tuesday saw the deadline for written confirmations of APIs imported from 3rd countries not on the 'White list'.  This overview provides resource for these requirements and covers potential problems with German custom officials. UK Law has yet to incorporate this requirement, as detailed here.

WHO outlines proposed Good Pharmacopoeial Practice (GPhP) 

These proposed guidelines aim to promote harmonisation of pharmacopoeial monographs.

Thymoglobuline recall (MHRA)

Genzyme are recalling  a batch of thymoglobuline due to stability issues.  This is an example of a company led recall as opposed to the standard ‘Drug Alert’ response.  Note these recalls do not have a statutory time limit for action and as they are not as well distributed through primary/secondary care they can often go unnoticed.

Benztropine Recall (FDA)

Fresenius Kabi are recalling a number of batches due to presence of glass particles within the vials.  The FDA recall alert provides a good overview of the risks of injecting glass particles.  Compare the risks to the patient if the product were an oral liquid.  You may have more to consider then just the affect to the internal organs – think about patient compliance & confidence in your product.

Bacterial Adhesion & Biofilm

Another good overview of how bacteria adhere to surfaces and formation of biofilms.

Hepatitis B Vaccine Recall (FDA)

MSD are recalling a single batch due to potential for cracked vials.  As with all sterile products once you have a defect that reduces your sterility assurance level a recall is pretty much a given.

WHO Public Inspection Reports Website

My Sponsor discovered this site recently which provides a good selection of public WHO inspection reports for a number of finished product manufacturers, API manufacturers, QC laboratories and CROs.  The audits are based on relevant WHO guidelines for countries generally outside of ICH.  The API manufacturer inspection reports are particularly useful and relevant now that the EMA has stated on the API written confirmation template that WHO GMP guidelines are considered equivalent to EU GMP.