IPEC e-newsletter - Excipients Insight June 2018 - 19-06-18


Inside this issue


PIC/s formally adopts EC's excipient GMP risk-assessment guidelines

At its meeting in April, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) officially adopted the transposition of the European Commission Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.

The guidelines will enter into force on 1 July 2018, on a voluntary basis for non-EU/EEA PIC/S participating authorities. According to PIC/S, “transposition of these guidelines further strengthens harmonisation between PIC/S and the EU and are in essence equivalent with some minor editorial differences. The guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities is also closely linked to revised Chapter 5 of the PIC/S GMP Guide.”

As a reminder, IPEC Europe has also worked hard to develop guidance to help organisations meet the regulatory requirements for GMP for excipients, for example with an update to the Joint IPEC-PQG Good Manufacturing Practices Guideline last year and the publication of our ‘How-To' document on Risk Assessment in 2016.




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