Will there soon be obligatory GMP Regulations for Excipients?
Amendments to the draft guideline on combating counterfeit medicines have been proposed, stipulating obligatory GMP Regulations for excipients, as well as an official obligatory inspection of API manufacturers. Read more on this here.
The APIC Publishes Templates for Quality Agreements
Not long ago, the APIC published a guideline and templates for quality agreements with API manufacturers. These templates cover everything that needs to be regulated between customer and supplier with regard to all relevant GMP aspects of API manufacture. Here you can read more.
The EDQM announced the suspension of two CEPs after an inspection and the withdrawal of two CEPs. In all cases manufacturers from China and India are affected by these measures. You will find more here.