PIC/S adopts EU GDP Guidelines - 07 Aug 2014
The Pharmaceutical Inspection Co-operation Scheme PIC/S has published a PIC/S Guide to Good Distribution Practice for Medicinal Products (PE 011-1). This Guide is based on the EU GDP-Guidelines (2013/C 343/01) and quotes the EU Guide in almost all entirety.
However, EU specific references have been removed and some terms replaced; for instance "must" is often replaced by the term "should". In addition, a dedicated Responsible Person is not required by the PIC/S document. Rather it talks about "designated responsible person(s)" or "designated person(s)". As a matter of fact, Chapter 2.2 "Responsible person" of the EU GDP Guide is not quoted in the PIC/S document.
Other changes include the coverage of import activities by the PIC/S Guide as the EU GDP Chapter 5.9 "Export to third countries" has been amended and now also covers import activities. The structure of the PIC/S document has been aligned with the structure of the EU GMP Guidelines, including 9 chapters:
- Chapter 1 Quality Management
- Chapter 2 Personnel
- Chapter 3 Premises and Equipment
- Chapter 4 Documentation
- Chapter 5 Operations
- Chapter 6 Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
- Chapter 7 Outsourced Activities
- Chapter 8 Self-Inspections
- Chapter 9 Transportation
As with the EU Guidelines, Risk Assessments will become a key tool for implementation of the new requirements.
PE 011-1 is now an official PIC/S guidance document. This does not mean that it is automatically in force in all PIC/S member states. It is a non-binding guidance and PIC/S Participating Authorities need to decide whether it should become a legally-binding standard and then implement it accordingly. Implementation should take into consideration national legislation. In some PIC/S countries for example, importation may fall under GMP and a manufacturer's license may be required.
Currently, PIC/S has 46 Participating Authorities, including most EU Member States, Switzerland, Japan and the USA.