Serialisation: New Guidance for EU Inspectors

Recommendation

13/14 June 2023
Vienna, Austria

GMP and Quality Requirements for Radiopharmaceuticals

Back in 2011, the European Commission (EC) published Directive 2011/62/EC, the so-called Falsified Medicines Directive (FMD).The main goal was to support the fight against counterfeit medicines. The new Directive had quite some influence on the pharmaceutical supply chain. It further introduced numerous Delegated Acts requiring certain safety features (Unique Identifier and Anti-Tampering Device), had some impact on revisions of several chapters of the EU-GMP Guidelines and led to a complete revision of the EU-GDP Guidelines.

In 2016, Commission Delegated Regulation (EU) 2016/161 was officially published, laying down detailed rules for the safety features and coming into force on 9 February 2019. GMP inspectors started looking thoroughly into the implementation during their site inspections. Now, The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the regulation.

Questions listed in the document focus for example on:

• Connection with hub and On-Boarding Partner (OBP)
• Data Flow
• Generation of Serial Numbers (SNs)
• Uploading of information in the repositories system
• Application of the Anti-Tampering Device (ATD)
• Packaging Lines
• Composition, Decommissioning, status change of the Unique Identifier
• Quality of the printing of the 2D barcode
• Alert Management