The full version of this counterfeiting feature can be read in the July issue of our digital magazine: http://www.pharmtech.com/ptedigital0710
Wyatt Earp, the legendary sheriff of Tombstone used to solve troubles in a simple way: aiming, pulling the trigger and bang! ... problem eliminated! Some manufacturers check the readability of their barcodes in the same way: pointing, pulling the trigger and beep! However, do they really solve the issue? Unfortunately, no.
Before looking at the details, let us ask why barcode quality is a hot topic for the pharma industry. The primary reason is because of the mass serialisation of folding boxes, which has been mandated by several health authorities including France and Turkey, based on Data Matrix barcode technology. Therefore, maintaining an acceptable level of barcode quality in pharmaceutical production processes will be an increasingly important task, and a legal requirement.
The error-free readability of the code should be guaranteed throughout the global supply chain. The barcode issuer is responsible for the barcode's readability by all readers, including older and even worn out readers. Just using a normal handheld reader to check the readability of the code is not sufficient because its reading quality is not defined. Instead, specialised testing equipment and measuring procedures are required, and a full range of ISO/IEC standards have been created to define barcode quality levels (grades) and measuring systems (verifiers), as well as the related testing methods.
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In this article, I will show why assessing barcode quality is important and will report on some of my own experiences from the practice.
Legal requirement/needs for quality assurance
The fight against counterfeiting and the need to assure patient health are the main drivers for deploying mass serialisation on pharmaceutical products — applying a unique code to each package dramatically increases the transparency of the supply chain and makes criminal activities easier to detect. Because of the advantages, mass serialisation is being promoted by many health authorities, including those in Brazil, China, India and Spain; however the main drivers of implementation at the moment are the following:
- The EU Commission has specified in the "Directive of the European Parliament and of the Council" amending Directive 2001/83/EC dated 10 December 2008 actions to be taken by member states to protect patient safety.1 A special emphasis is on mass serialisation.
- Based on Section 505D of the US Federal Drug and Cosmetics Act, the FDA has the obligation to develop a standardised numerical identifier for prescription drug packages. In January 2009 the agency published a draft guidance2 specifying the need for mass serialisation.
- The Article R512458 of the French Public Health code was amended and published in the Official Journal on 24 August 2008. It specifies that "for each incoming and outgoing transaction, the number and expiry date of all batches must be recorded together with the quantities supplied or received per batch. This shall become compulsory on 31 December 2010".3 The outer packaging of medicinal products shall bear the CIP13 code, batch number and expiry date, marked in plain text, and ECC 200 Data Matrix marking will be used. As it is necessary to encode variable data into the Data Matrix code, inline coding directly on the packaging line is the most appropriate solution. The code quality has to be assessed based on the ISO/IEC 15415 standard and the required minimal Data Matrix barcode quality grade has to be C(1.5) — for details regarding quality grades see the section below.
- The Turkish Ministry of Health, G.D. of Pharmaceuticals and Pharmacies has published in its guidance on the use of barcoding and identification,4 the principles related to the identification and barcoding of medical products for human use. Article 10 mandates that the barcode quality level has to be measured based on ISO standard 15416 for linear and 15415 for Data Matrix barcodes. In article 12, it is specified that the minimal Data Matrix barcode quality grade of the barcodes shall be at least D(0.5).