GMP News - APIs and Excipients


Further CEPs suspended and withdrawn by EDQM

The EDQM continues to inspect manufacuturers of APIs - especially in Asia. As a consequence further CEPs were suspended or withdrawn. You will find more information here.



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.



EDQM announces new System for Revision/Renewal of CEP Certificates

In January the European Directorate for the Quality of Medcines and Health Care (EDQM) announced a new system for the revision and renewal of CEP certificates. Read on.



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.



EDQM Announces the Suspension of Further CEPs

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.


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