Friday's Round Up

USA on API white list

From next week the USA will be on the EU's white list regarding written confirmation of API imports from 3rd countries.  The USA now joins Australia, Japan & Switzerland on the white list.

Class 1 recall – Ambisome Injection

Potential lack of sterility assurance was the typically vague term used by the DMRC in describing the reason behind this recall.  Unfortunately no further information is provided  but it is worth considering the possible causes such as primary container defects, media fill results, PV complaints….  Ambisome is a critical product so a recall indicates the severity of the problem.

Aspirin tablet recall (FDA)

An example of segregation/line clearance error during packaging.  The aspirin bottle actually contained paracetamol tablets.  This should immediately draw your attention to the potential extent of the problem – ie where have the aspirin tablets gone? (in the paracetamol labelled container perhaps?  which would have the greatest risk to patients? - this is where your medicinal chemistry should help in your assessment!)

WHO guideline on QRM

These guidelines build on Q9 and provides more detailed information regarding the implementation of QRM.

EMA Q&A – Annex 1 bioburden

EMA clarifies the point at which bioburden testing should be performed (immediately prior to filtration) and bioburden limit (10cfu/100ml).  This is part of the ongoing GMP Q&A section of the EMA website that gets updated periodically but without much fanfare.

EMA guidance update on ASMF submission

This provides some details on the letter of access that API manufacturer’s use to give the regulatory authority permission to review all the commercially sensitive data regarding the API manufacturing process.   The withdrawal of access letter has been given more guidance for when API manufacturer changes or the ASMF is replaced by the CEP.

Single use Technology for biotechnology manufacturing

A useful insight to the disposable systems in use for biotechnology manufacture.  These remove the need for cleaning validation, reduce contamination and saves significant time where cleaning of multi use biotech equipment can significantly reduce the available manufacturing capacity.

Pharmafile provides a nice overview of MHRA action regarding API importation (as mentioned in last week’s post)

Happy reading!