PIC/S Committee has Adopted a Guide on Good Distribution Practice

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.

The PIC/S GDP Guide is a non-binding guidance document because PIC/S is not a regulatory authority in the sense of the competent authorities in the EU and the regulatory authorities in the US, Canada, Australia and Japan.

Each of the competent authority PIC/S members will make the decision regarding whether the guideline is to be implemented and enforced. Several regulatory authorities outside of the EU are members of PIC/S including the US, Canada, Japan and Australia. How this will be applied by those authorities is unknown at this time.

While the PIC/S guideline is based upon the EU GDP Guide and Chapters 1 through 9 have the same structure as the EU guideline, the following differences are noted with regard to the PIC/S GDP Guideline:
• EU specific references have been removed
• Import activities are included
• “Responsible Person” is replaced by designated responsible person(s)
• Contains more references to risk management throughout
• Additional reference are made to record(s)/procedure(s)s that should be maintained
• Batch/expiry guidance is based upon national legislation
• Contains more general requirements for import/export (not EU specific)
Includes more detail on actions taken upon identification of falsified medicines, including recall guidelines
• Does not contain a chapter on Brokers as in the EU Guide
• Lists additional glossary terms; including temperature, with defined ranges.

To view or download the PIC/S GDP Guidance, click here