Representatives of the State Service of Ukraine on Medicines and Drugs Control participated in the 7th International PICS Expert Meeting on Good Distribution Practices

The 7th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP) was held on September 24-26, 2024 in Malta. Representatives of the State Service of Ukraine on Medicines and Drugs Control participated in this meeting. The event joined together inspectors from different PIC/S member countries to share experiences and improve inspection practices at the international level. The meeting was organized with the support of the Malta Medicines Authority (MMA).

Speakers from Malta, South Africa, the United Kingdom, Singapore, Ireland, Spain, the United States, the Netherlands and other PIC/S member countries shared their experience with the roundtable participants. A wide range of topics was covered during the three active training days.

First of all, the meeting focused on the implementation of guidelines related to the Joint Inspection Programs (JAP) for GDP inspectors within the EU4Health program, as well as the development of the PIC/S GUIDANCE ON CLASSIFICATION OF GDP DEFICIENCIES procedure, which will contain an algorithm and examples of violations identified during inspections for compliance with GDP requirements.

During the discussion, the participants focused on supply chain risk management issues related to complex global supply chains and their constant transformation under the influence of technology and crises such as pandemics. They discussed ways to reduce drug counterfeiting and unauthorized supply chain interference, as well as important aspects of equipment qualification and transportation process validation.

During the meeting, the participants also discussed the regulatory requirements and the role of the Responsible Person in the distribution process, some differences in the responsibilities of this position compared to the Qualified Person in accordance with the requirements of Good Manufacturing Practice (GMP) and the prospects for using the latest technologies, such as unmanned aerial vehicles (drones), for the medicines delivery.

Based on the experience of the U.S. Food and Drug Administration (FDA, Office of Drug Security, Integrity, and Response (ODSIR), the importance of integrity and reliability of the drug supply chain using the generation of unique identification codes for packages (serialization) was highlighted.

The main focus during all days of the expert circle was instruments for protecting medicines consumers from counterfeiting. A representative of the UK Medicines & Healthcare Products Regulatory Agency (MHRA) inspectorate gave examples of detecting counterfeit medicines taking into account the challenges associated with the development of modern technologies, such as the use of fake domain and email addresses and similar tools by criminals.

In addition, as part of the working group meetings, situational exercises were conducted for GDP inspectors. The case studies simulated circumstances that could complicate the work of inspectors and negatively affect the inspection process. The joint work on such tasks among representatives from different countries made it possible to share skills and experience, discuss the specifics of national legislation and consider opportunities to improve the efficiency of inspections to ensure the safety of medicines on their way to the customer.

As a result of the meeting, it was decided to create a Question & Answer document on the PIC/S GDP Guide and to prepare a draft PIC/S Guide on the classification of non-compliances identified during the Good Distribution Practice inspection.

The State Service of Ukraine on Medicines and Drugs Control expresses its gratitude to the USAID Project «Safe, Affordable and Effective Medicines for Ukrainians» (SAFEMed) within the framework of cooperation according to the Memorandum of Cooperation signed between the State Service of Ukraine on Medicines and Drugs Control and the international organization “Management Sciences for Health, Ink”.