Top Tips for Protecting your Pharmaceutical Products
Contamination and counterfeit medicines are one of the biggest issues facing the pharmaceutical industry. With the drug development process usually taking roughly 10-12 years for a drug to enter the market, it is vital that all information presented is compliant with regulatory requirements. This includes the Medical Device Regulation (MDR), the Falsified Medicines Directive (FMD), the Identification of Medicinal Products (IDMP), and the Drug Supply Chain Security Act (DCSCA) as mentioned in a previous article. This article will focus on how packaging and labelling products can be better monitored and protected.
When it comes to counterfeiting pharmaceutical products, the best solution is to serialize those products with QR and bar codes that contain a unique identifier of data. These are in the forms of serial numbers and expiration dates so they can be monitored and traced by their manufacturers.
Serialization became a legal requirement by the Food and Drug Administration (FDA) in the US from 2017, called the DSCSA. The aim is to protect consumers from counterfeit, stolen and harmful drugs from entering the market. This is ensured and monitored by the DSCSA, as wholesale distributors and third-party logistics providers are required to annually report to the FDA their national license standards, outlining all of their activities.
Machine Vision Systems
A machine vision system (MVS) is a technological computer that examines, evaluates and identifies still or moving images. They are used to inspect every product to detect faults in packages before they are sold to the public, such as the print quality, number verification, carton and plastic damage, and all contamination possibilities. There are a variety of easy set-up and simple to use technological products and machines used, including digital cameras, robot inspection cells, and packaging and labelling inspection machines. To ensure your packages are compliant to the FDA regulations, you must purchase an MVS for guaranteed results on the legitimacy of your product.
Planning ahead with knowledge on regulations, distribution timings, and particularly environmental conditions are valuable for the success of the product. Packaged products are required to maintain a certain temperature level during the transportation period in order to stay authentic. This can range from 2 to 8°C, but can sometimes be as low as -79°C for specific products. They may also require additional environmental support to improve their storage life and quality, such as oxygen, humidity and carbon dioxide. This can all be tracked by a tattle-tail indicating device, which notifies if a product’s temperature level was exceeded and indicate if a product can no longer be used.
Would you like to find out more about how you can protect your products? This November, the Pharma and Device Packaging and Labelling West Coast 2018 conference takes place in Burlingame, California. Hear more about serialization, cold packaging and more innovative technologies from Packaging and Labeling experts, to ensure your designs comply with the latest regulations. For more information, please visit http://www.arena-international.com/pharmapackagingwest or alternatively email us at: firstname.lastname@example.org
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