Meeting Global Standards & Barcode Compliance for Pharma Serialisation

AS Arun Kumar of Sandilyam Automation Systems shares global standards and compliance on ISO/IEC barcode verification for pharma as per serialisation.

Major pharma companies have been working on the needs for marking their products and labelling them with appropriately selected barcode symbols over different packaging levels. This is to be of course 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 handling and of course finally consuming the product.

Often there has been a common misconception to use a reader or a scanner for checking that the barcode is alright and that 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.

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 analysed and reported Meeting Global Standards and Barcode Compliance for Pharma Serialisation comprehensively. Importantly the clarity of the barcode grading process and quality of the symbol as assessed by the verifier is really what the manufacturer and any packaging printing company should ever work to comply with. Meeting the standards ensures that the product packaging would be far better placed to be read without hassles along its journey, be it shipper, secondary or primary packaging levels.

What goes unsaid is also the fact that the Quality,Production and Engineering teams would be well benefitted in understanding the results from the barcode verifier. This really is a vital diagnostic tool to correct any mistakes in any aspect of the final printed symbol.

With the verifier delivering comprehensive and repeatable analysis, the information provides an invaluable insight into the usage of the GS / FNC1, the right symbologies, the dimensioning,data encodation and of course the region-specific compliance reporting too. This report becomes therefore the valid and globally compliant record of barcode quality for the manufacturer and the printing companies 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 organisations. 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, analyse and improve barcode compliance for better scann ability

The GS1 Data matrix 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 Data matrix 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, analysing the barcode at a fixed, known distance and angle. Meeting Global Standards and Barcode Compliance for Pharma Serialisation 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 orBrazil 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 vitalcog in the wheel of data traceability, along the journey of the product, ever so critical to all stakeholders of the health industry.