New PIC/S Guide for the Inspection of Packaging Processes and Facilities

In January 2009, the PIC/S (Pharmaceutical Inspection Convention Co-Operation Scheme) published a new Aide-Memoire to provide guidance for inspectors inspecting packaging processes and packing facilities.

The Aide-Memoire PI 028-1 draws attention to the fact that the number of defects in medicinal products attributable to deficiencies in the labelling and packaging process is on the increase. Therefore the PIC/S Seminar 2005 in Bucharest was dedicated to packaging. This Aide-Memoire is the outcome of the PIC/S Seminar 2005.

The purpose of this document is to provide guidance for inspectors in preparation for inspections in packing facilities (primary as well as secondary). It aims to define the minimal requirements acceptable for an inspector as well as the best practices.

The document lists possible questions in tabular form as well as referrings to the corresponding guidelines. The following items are discussed:

  • Purchasing
  • Receipt 
  • Storage areas
  • Quality control
  • Premises
  • Packaging equipment and process
  • Documents
  • Personnel
  • Quality assurance

You can find the new document here.

Dr. Robert Eicher
On behalf of the European Compliance Academy (ECA)

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