Regulatory Update

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two new English language documents for GDP inspectors, which came into force on 01 February 2023. The documents were prepared by the PIC/S Expert Circle on GDP and are available for free download as PDF files from the PIC/S website.8 The first document is titled “Aide-Memoire on the Inspection of Good Distribution Practice (GDP) for Medicinal Products in the Supply Chain” The main body of the 22-page publication consists of a total of 10 tables that contain general aspects and specific issues to be considered during a GDP inspection. The tables also include references to supporting documents. The second new document is entitled “Questions & Answers document regarding the PIC/S GDP Guide (PE 011-1)”. Here, the questions and answers refer to the “PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products” of June 2014. On a total of 11 pages, various questions regarding the individual chapters of the PIC/S GDP Guide are answered.
With regard to developments in the UK, reference can first be made to the new 5th edition of the “Rules and Guidance for Pharmaceutical Distributors” (the “Green Guide”), compiled by the Medicines and Healthcare products Regulatory Agency (MHRA). The publication became available in March 2022 and supersedes the 2017 edition. The Green Guide includes current EU guidelines on good distribution practice, as well as key UK regulations, directives and guidelines. The collection has been updated to reflect changes following the United Kingdom’s withdrawal from the European Union. It also includes new guidance on pharmacovigilance for wholesalers, naming sites on a license, self-inspection and the responsible person for import (RPi). The Green Guide is published by Pharmaceutical Press. One innovation concerns the pilot program for monitoring GMP and GDP activities, launched in mid-2022, under which approved consultants, known as Compliance Monitors (CMs), oversee the implementation of an agreed Compliance Protocol (CP). Individuals applying for this program must meet certain requirements. These include at least five years of experience in conducting independent audits of GMP/GDP companies. In order to be a CM specifically in the GDP field, sufficient experience is also required in relation to the distribution activity carried out by the company in question.