Tuesday, September 26, 2023

Meeting global standards and barcode compliance for pharma serialization

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Major pharma companies have been working on the needs for marking their products and labeling them with appropriately selected barcode symbols over different packaging levels. This of course should be done with high data integrity and traceability. Any incorrect data or non-readable barcode symbols would lead to problems for the product movement along the supply chain. The challenge here is to provide the right and readable information to all stake holders and finally consuming the product. Often there has been a common misconception to use a reader or a scanner for checking whether the barcode is alright and the information encoded is accurate. Often followed by many manufacturers to report the barcode data, this rather inadequate and rudimentary check in many instances is also done by the packaging suppliers included.

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It is needless to say that a scanner would be required at the point of sale or warehouse to merely read the barcode symbol. This is limited to data capture alone, and needed as a source of input of the barcode information into the ERP, WMS, retail POS and so on. Hence called a barcode reader!

Reading of the barcode, as evident provides no authentication or check, on the accuracy of the symbol itself in all its aspects. Errors can also occur in reading the right barcode information as per the reflectivity of the optics which can vary by the scanner types and even as per the algorithms used in reading. This really begs the question, how would one know if the barcode is encoded, designed and printed properly apart from being fit for use?

Increased importance of barcodes, moving along the supply-chain

The increased level of dependency on barcode symbols for automatic identification has transformed it from a tool of mere identification to that of product traceability. Therefore, data accuracy and readability have assumed far greater importance along the products movement on the supply chain. Aspects such as the defined ISO/IEC standards relevant to Linear and the 2D matrix codes assume criticality in ensuring readable codes on packaging. The ISO/IEC verification process also defines angle of illumination, the aperture of reading that lends the most critical aspect of repeatability on quality inspection of the matrix codes. Through a true ISO verification process all defined parameters are analyzed and reported involved in generating barcode symbols.

The regulations defined by the recent US HDA and European standards for the pharma manufacturers also include the CMO or contract manufacturing organizations. The key to sustain these challenges faced by the pharma manufacturers in the global supply chain, is to deliver the right level of data traceability with compliance reporting. These guidelines applicable as per country-specific applications is growing multi-fold as we speak, and importance felt by countries like Russia as per their pharmacy guidelines implemented recently. The aim remains traceability and the tools need to work right each time.

Measure, analyze and improve barcode compliance for better scanability

The GS1 Datamatrix symbology has been almost the universal choice of symbology within the pharma industry (apart from GS1-128 linear codes) to define the traceability within the supply chain. It has well defined structures, and starting from the smallest size around 8 mm to a maximum size of data capacity which can encode alpha and numeric characters up to 3116 characters in the largest 144 modules square symbol, the ECC 200 Datamatrix is now integral to the process. The reliability of the reading methods used in online scanners can be often misleading and questionable.

Inline validation systems are intrinsically not ISO compliant, although many of them can produce some basic reports based on select ISO parameters for barcode quality. The report is not what makes a reader into a verifier – the testing instrument itself is what makes the verifier. To be an ISO-compliant verifier, the device must demonstrate that it measures and grades to the defined international standard within published tolerances, under specific, controlled lighting conditions, analyzing the barcode at a fixed, known distance and angle.

Meeting global standards and barcode compliance for pharma serialization

Compliant barcode verifiers eliminate the influence of ambient light; ten-scan averaging of 1D barcodes is recommended. All of the ISO parameters must be tested and graded; so-called ‘partial ISO grading’ is simply not compliant. Further, the data validation too is imperative apart from quality assessment. So this makes reporting on GS1 compliance, and regional compliance including DAVA guidelines, CIP, Russian, European guidelines, Turkish healthcare or Brazil guidelines, important.

The successful scan of a barcode is not meaningful if ‘successful’ means that data – some kind of data – was captured. Only an ISO compliant verifier can authoritatively decode and grade a barcode and predict future scanning success with virtually any type of scanner. To meet the health care guidelines it is important for the pharma manufacturers to check quality of the product packaging barcode symbols. The importance of a standalone ‘judge’ performing the task of verification irrespective of the printing process, is indeed a very vital cog in the wheel of data traceability, along the journey of the product, ever so critical to all stake holders of the health industry.

The editorial team of The Packman who handle all the press releases with Sunil Jain working as the desk editor.

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