The previously published Aide-Memoires for GDP and GMP Inspections regarding compliance with Delegated Regulation (EU) 2016/161 for Safety Features are now accompanied by a third one for Pharmacy Inspections. The European Commission published these Aide-Memoires to help manufacturers, wholesalers, pharmacies and inspectors to verify compliance with the regulation.
Commission Delegated Regulation (EU) 2016/161 details the characteristics of the safety features, how medicines should be verified and by whom. The Delegated Regulation and the required medicine verification system have been applying since February 9, 2019.
Aide-Memoires for GMP and GDP Inspections
The two Aide-Memoires for GMP and GDP Inspections deal with general topics, such as records, returns, suspected falsification, decommissioning of unique identifiers (UIs), training, outsourced activities. In addition, specific topics are covered, like, for example, aggregation ("Is aggregation implemented?", "How is the integrity of an entire aggregated shipment / pallet verified?"), removing or replacing of safety features, operations specific to parallel importers & distributors. The documents also contain references to guidelines and articles within Regulation 2016/161.
What are the obligations of persons authorized or entitled to supply medicinal products to the public?
Connection to Repository System & Software, e.g.: - "Have you registered with the National Medicines Verification Organization (NMVO)?" - "Is the pharmacy connected to the national repository system? What was the date of connection?" - "Is software implemented for verification and decommissioning of safety features?" - "Do software-updates occur and is there evidence of these updates?" - "Does the pharmacy software generate a reminder of the obligation to verify and decommission the UI at the time a pack is supplied? - "Does the pharmacy software allow the release of a pack without the verification process and decommissioning of the UI?"
Technical Requirements & Training, e.g.: - "Are all dispensing stations in the pharmacy equipped with a scanner? Is the number of scanners appropriate?" - "Have relevant personnel received training in the procedures and activities related to the safety features? Does this include training in the handling of alerts and how to deal with them?" - "Is there a document available containing instructions for alert handling and how to deal with them?
Verification of Safety Features & Decommissioning, e.g.: - "When verifying the safety features, are the following verified? (a) The authenticity of the UI; (b) The integrity of the anti-tampering device (ATD)." During inspections it would be requested to see records of checks completed related to the UI verification and an overview of alerts and actions taken. - "Under what circumstances is the reversal of the status of a decommissioned UI to an active status permitted? Is this covered by a procedure?" - "Is the pharmacy verifying the safety features and decommissioning the UI in other cases (not for supply)?" (e.g. packs that cannot be returned to wholesalers / manufacturers or are requested as samples by competent authorities) - "When only part of a pack is supplied, are the safety features verified and the UI decommissioned when the pack is opened for the first time?" - "Where technical problems prevent the verification and decommissioning of a UI at the time of supply to the public, how is this situation handled? Are there any records about these cases?"
Suspected Falsification & Alert Management, e.g.: - "Where there is reason to suspect that packagings have been tampered, or the verification of the safety features indicates that the product may not be authentic, what arrangements are in place to ensure that the product is not supplied?" - "How are the relevant competent authorities informed and within what timeframes?" - "Is the pharmacy connected to any IT system for alert management?" - "Is the pharmacy checking the status of the investigation in case of alert?"