Two New PIC/S GDP Guidance Documents Published

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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two guidance documents for GDP inspectors, an Aide-Memoire on GDP inspections and a Q&A document.

According to a press release, these documents have been prepared by the PIC/S Expert Circle on GDP and entered into force on 01 February 2023. Both publications are available for download as a PDF file free of charge on the PIC/S website.

Aide-Memoire on GDP Inspections (PI 044-1)

The first document is entitled "Aide-Memoire on the Inspection of Good Distribution Practice (GDP) for Medicinal Products in the Supply Chain". The document contains a total of 22 pages.

According to section 3.1, "the purpose of this document is to provide guidance for GDP inspectors to assist in training and preparing for inspections." To be precise, it is about GDP inspection of manufacturers and wholesale distributors. In section 2.5 it is pointed out that it is a "voluntary guidance document" and that it "is legally non-binding unless it has been declared a legal standard in the jurisdiction of a Participating Authority"

The main part of the PDF file consists of in total 10 tables, which contain general subjects and items to be investigated during a GDP inspection. The tables also include references to supporting documents. The following areas are covered:

• General
• Quality Management
• Personnel
• Premises and Equipment
• Documentation
• Operations
• Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
• Outsourced Activities
• Self-Inspections
• Transportation

Q&A Document (PS/INF 22/2017)

The second new document bears the title "Questions & Answers document regarding the PIC/S GDP Guide (PE 011-1)" Thus, the questions and answers refer to the "PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products" from June 2014, which can also be downloaded from the PIC/S homepage.

On a total of 11 pages, various questions regarding the different chapters of the PIC/S GDP Guide are answered. This includes, for example, the following aspects:

• "How is the effectiveness of the quality system monitored?"
• "Is the wholesaler responsible for ensuring GDP compliance of the outsourced activity?"
• "What is meant with “acceptable temperature limits”?"
• "What is acceptable time limit for return to saleable stock?"
• "Should the transportation company hold a wholesaler’s licence?"