Pharmaceutical Technology Europe - July 2010 - (Page 4)

EU anti-counterfeiting legislation on its way To combat the increasing threat of counterfeit medicines, the European Parliament and the Council of the EU are amending the current anti-counterfeiting directive (Directive 2001/83/EC), which is due to be completed before the end of 2010, to include a requirement for features that enable the identification, authentication and traceability of prescription medicines. Once this legislation is passed, all European member states will have to implement local legislation within 24 months. Given the legislation’s short timeframe, it is imperative that pharmaceutical manufacturers begin to examine and invest in a solution as soon as possible. The only way a specific product can be identified, authenticated and traced effectively is to give it a unique identity. As such, serialisation, which assigns a unique identity via a unique identification number to each product through a vehicle, such as RFID or 2D barcode, is the only solution that can comply with the directive. Identification, authentication and traceability Identification, authentication and traceability require very high quality serialisation data. Aside from simply placing a unique number on a package, serialisation technology must also allow a manufacturer to know which numbers have been assigned and placed on which of their products and batches; to be aware of which serialised products are in the supply chain or have been consumed; and to obtain updates regarding the status of specific serialisation numbers in the case of recall, illegal importation or theft. To ensure data integrity is maintained throughout the packaging process, serialisation solutions must: • control the numbers issued to a particular packaging line for a particular process • assign and verify unique identification numbers at the item level, track items through the packaging process, and establish relevant parent-child relationships between item, case, and pallet Graham Smith • assign numbers Aegate randomly rather than in sequential order • accurately account for numbers that may have been assigned to packages that were rejected during packaging both on and off of the line • associate serial numbers to the correct lot/batch information. Because of the unpredictability of future serialisation regulations, manufacturers should be examining solutions that can respond to current and new demands quickly and cost effectively. Ideally, the solution should be configurable so that it can manage both small and large throughputs and is also capable of expanding as new requirements are introduced. PTE Based on contributions by Frederic Menardo, General Manager Europe at Systech International, and Graham Smith, Senior VP of Business Development at Aegate. To read the full version of this article, go to www.pharmtech.com/menardo www.systech-tips.com www.aegate.com 1 CONTENTS 8 EDIBLE MICROTAGS 3 OVERCOMING OBSTACLES 9 X-RAY ANALYSIS 4 EU LEGISLATION 11 RAMAN SPECTROSCOPY 6 DATA MATRIX CODES 14 TOP TECHNOLOGIES http://www.pharmtech.com/menardo http://www.systech-tips.com http://www.aegate.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - July 2010

Pharmaceutical Technology Europe - July 2010
Can Pharma Keep Pace with the Counterfeiters?
Obstacles to Implementing an Effective Anti-Counterfeit Strategy: Can They Be Overcome?
EU Anti-Counterfeiting Legislation on its Way
You Can't Control What You Can't Measure
Data Matrix Barcodes: Points to Consider
Authenticating Drugs with Edible Microtags
The Power of X-Ray Analysis
NIR Chemical Imaging Could Hold Key Data
How Raman Spectroscopy is Benefitting Developing and Developed Countries
Overt Versus Convert Technologies
Serialisation is Here to Stay
Eight Latest Technologies Showcased

Pharmaceutical Technology Europe - July 2010