PIC/S adopts EU GDP Guidelines

Recommendation

13/14 December 2023

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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 almost completely.

However, EU specific references have been deleted and the term "must" is often replaced by the term "should". A dedicated Responsible Person is not introduced by the PIC/S document. It talks about "designated responsible person(s)" or "designated person(s)". Chapter 2.2 "Responsible person" of the EU GDP Guide is not quoted in the PIC/S document.

Also import activities are covered by the PIC/S Guide. EU GDP Chapter 5.9 "Export to third countries" has been amended and also covers import activities. Chapter 10 "Specific provisions for brokers" has been deleted completely.

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.