PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP)

22/05/2014 09:21

The PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP), which will enter into force on 1st June 2014. The PIC/S GDP Guide is based on the EU GDP Guide.

 

While the EU GDP Guide is legally binding in the EU/EEA, the PIC/S GDP Guide is a non-binding guidance document in PIC/S, as not all PIC/S Participating Authorities are competent for GDP inspections. The GDP Guide will be posted on the PIC/S website shortly before its entry into force.

Furthermore PIC/S announced that during its meeting in Rome a few days ago, Japan and Korea were invited to join PIC/S as of 1st July 2014. Japan will become the 45th PIC/S Participating Authority and will be represented by the Pharmaceutical & Food Safety Bureau of the Ministry of Health, Labour & Welfare (MHLW), the Pharmaceutical and Medical Devices Agency (PMDA) and the GMP Inspectorates of Japan's Prefectures. Korea's Ministry of Food and Drug Safety (MFDS) will become the 46th PIC/S Participating Authority. Both, Japan and Korea applied for PIC/S membership in spring 2012.

The number of PIC/S members will continue to grow as the Thai FDA has already announced to apply for membership as well.

Source:

PIC/S News