Active Pharmaceutical Ingredient GMP non-compliances listed in the EUDRA GMP database do not only affect suppliers from Asia

The EUDRA GMDP database represents an interesting tool and information source concerning GMP/GDP compliance of global manufacturers. Since most of the APIs are nowadays manufactured in Asian countries such as China and India, often API manufacturers/suppliers from these countries are subject to listings in the “GMP Non-compliance” part of the database. However, as can be seen from the most recent listing, also European API manufacturers are subject to GMP non-compliance findings and subsequent listings in the database.

In this situation, two actual Guidance documents from industry organizations, one published by the Active Pharmaceutical Ingredients Committee (APIC) for APIs and the other published by the International Pharmaceutical Excipients Council (IPEC) for Excipients, provide helpful insights and support. Considering the ICH Q9 guideline, thereby the risk associated with (foreign) particles from APIs or Excipients in drug products may be more easily understood and can thus be adequately managed.

Direct link to the concerned database list:

QP declaration: public consultation input from stakeholders as well as EMA comments published

After issuing the final version of the QP declaration template in May this year (see also our Newsletter 4/14), now the input from stakeholders during the public consultation (closed in September 30th 2011) on the draft as well as the comments from the European Medicines Agency (EMA) have been published. The 93 pages document covers comments from 24 stakeholders. It represents a comprehensive and detailed summary about the EMA (regulatory) view on current requirements for QPs concerning adequate API (and other starting materials) supplier qualification. It therefore extends and further specifies the EMA view on this important topic as laid down in the respective Questions & Answers on GMP compliance for active substances on the EMA website.

The related documents are hyperlinked hereunder:

(EMA/337252/2014) (PDF)

Comments from stakeholders during public consultation concerning “The QP declaration template”


EMA Q & A on GMP compliance for active substances

Revised EU GMP Part II Guideline Basic Requirements for Active Substances used as Starting Materials published

The EU GMP Part II Guideline about the GMPs for APIs (“Basic Requirements for Active Substances used as Starting Materials”) has been slightly revised effective September 2014. Due to the completed revision of various Annexes to the GMP guide, Part I can no longer be followed for APIs used at starting materials. In addition, clarification of the relationship between section 17 of the guideline and the forthcoming guidelines on Good Distribution Practices for APIs has been added to section 1.2. Furthermore, an obsolete reference to Annex 20 in section 2.21 has been updated.

Major GxP Events IV/2014