Greetings from FMO 2016, Moscow
Greetings from ФармМедОбращение, Annual Russian Conference on State Regulation on Pharmaceuticals and Medical Devices, 2016 in Moscow. This has been a very interesting and insightful event with a number of excellent presentations. The Russian pharmaceutical regulators, as well as representatives of Russian pharmaceutical manufacturers and distributors clearly take a very professional attitude to improving and safeguarding the quality and integrity of the pharmaceutical manufacturing and distribution chain as a whole. It is, thus, time to give an update to my reporting on the developments of Russian pharmaceutical regulations.
Harmonization of regulations
The topics of the discussions have ranged from introduction of GxP to developments in serialization regulation and supervising the circulation of pharmaceuticals. The representatives of WHO and EFPIA discussed Good Regulatory Practices and GxP regulations around the world. The Russian regulators are keeping an eye on the developments in other markets, e.g., Brazil, EU and USA to create a working and well-designed system themselves.
Some differences in the style of regulation are problematic: there is a good reason that the regulations have defined some issues as recommendations and some others as requirements. An example was a requirements (elsewhere recommendations) on the lateral air flow in clean rooms. Even though this may be a cultural issue, defining recommendations as requirements may cause unnecessary problems in the production units.
Anti-counterfeiting measures, serialization
A few clarifications: Data Matrix is to be used for the machine-readable serialization. This was made clear in many presentations, especially by the government officials. The use of RFID for serialization has clearly been rejected for now.
Aggregation is also clearly on the table, to enable track & trace. Tamper evidence, while not often discussed in the news nor in the presentations, is also definitely going to be part of the legislation – for obvious reasons. Mikhail Murashko, Head of the Federal Service for Surveillance in Healthcare, said in the questions & answers part of a session: tamper-evidence will not be in the pilot projects during 2017 but will in the final legislation starting from 2018. There is still discussion if tamper evidence is going to be required for cheap products and if so, where is the threshold price.
The pilot is starting with 16 companies (one up from last news), 30 products. Mobile application for consumers was presented by Murashko, with information not only on manufacture but also on the path of the medicine package through the logistics chain. If that sounds like sci-fi to you, better check how you can track your next web shop purchase. This is something that EU and USA could also do, eTACT by EDQM did already include the idea.
An interesting usability issue was pointed out for the serialization pilot: should the aggregated barcode be marked with a pictogram to point out the meaning, so that the code would not be confused with other codes. Another usability issue raised was the change of format of the expiry date: customers in many market areas are used to date format MM/YYYY, thus having no value for day (meaning the end of month). When moving to new standards with DD/MM/YY type of notification on the Human Readable Information, it has to be communicated to the patients.
Risks in implementation
The federal officials were seriously concerned on pharmaceutical manufacturers delaying serialization and GxP projects until the deadlines are too close. As they said, it is normal human behavior to postpone cumbersome projects, but the projects need time to be executed. These are not simple production line upgrades, but information systems need an upgrade, too, and this all needs to be interconnected. The issue of machinery delivery times was also raised. Also the risks of unexpected delays and other project execution risks were discussed.
We at Servicepoint Oy are able to both plan and implement serialization and other automation upgrade projects on your production and packaging lines. Give us a call and we’ll see how we can help you.
Iiro Jantunen, D.Sc.
Chief Technology Officer
+358 44 7868 215