Regulatory Update
By Trillyum Consulting 2 min read Regulatory Updates
New PIC/S documents for GDP inspectors came into force on 1 February 2023, and the MHRA published the 5th edition of its Green Guide for pharmaceutical distributors.
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two new English-language documents for GDP inspectors, which came into force on 1 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.
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 ten tables that set out general aspects and specific issues to be considered during a GDP inspection, with references to supporting documents.
The second 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. Over eleven pages, questions regarding the individual chapters of the PIC/S GDP Guide are answered.
Medicines and Healthcare products Regulatory Agency (MHRA)
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has compiled the new 5th edition of the “Rules and Guidance for Pharmaceutical Distributors” (the “Green Guide”). The publication became available in March 2022 and supersedes the 2017 edition. It includes current EU guidelines on good distribution practice as well as key UK regulations, directives and guidelines, 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 licence, self-inspection and the responsible person for import (RPi). The Green Guide is published by Pharmaceutical Press.
One further development is the pilot programme 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 to the programme must meet certain requirements, including at least five years of experience conducting independent audits of GMP/GDP companies. To act as a CM specifically in the GDP field, sufficient experience in relation to the distribution activity carried out by the company in question is also required.