For most industries, packaging plays a critical role. From protecting and securing the product, increasing its appeal, to communicating important marketing and product information. However, printing errors on packaging can result in massive recalls and obsolete inventory costs for the Printer, whilst exposing them to risks due to regulatory non-compliance and lower product safety. When it comes to printing errors on pharmaceutical packaging, whether on the packaging itself, on an attached label or on an associated printed leaflet with the medication, this can have more serious, sometimes life threatening consequences.
In many countries, specific legislation govern what information needs to be printed on pharmaceutical packaging to combat the growing threat of counterfeit medicine. In Europe, for example the Falsified Medicines Directive (FMD) 2011/62/EU requires all medication to have a serialized number which enables the package to be tracked and traced throughout the supply chain. Also pharmaceutical packaging printers need to check the final print against the original approved artwork, and notify the authorities of any changes. It is estimated that 50% of pharmaceutical recalls are due to errors in product labelling or packaging artwork.
Furthermore printing errors such as missing, incorrect or unreadable medication names, strength, lot/serial numbers or expiry dates can confuse or mislead people into taking the wrong or inappropriate medicine. Error in dosage instructions where e.g. “2.5mg” appears as “25mg” or “2-3 tablets” is printed as “23 tablets”, can potentially cause serious harm or even fatalities. These printing errors could easily occur due to a number of prepress, production or operational issues. Blocked or misfiring inkjet heads, toner marks, dust, equipment/software glitches or human error (e.g. keying errors) could and do happen at any time. Manual print quality inspection or using strobed video web viewing systems (which monitor only small portions of the web), are grossly inadequate for catching small or random print defects, leading to higher reprint costs, inventory obsolescence and operational pressures – which impact profits, lower customer satisfaction and your ability to secure future business. In turn, if these errors go out undetected, the repercussions could be even worse, exposing you and your clients to negative publicity, damaging penalties, lawsuits and regulatory action.
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Pharmaceutical Packaging and Label Inspection
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