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Product Integrity and Quality Assurance for Sustainable Supply Chains
Product Integrity and Quality Assurance for Sustainable Supply Chains

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Date

29 April 2020

Product Integrity and Quality Assurance for Sustainable Supply Chains

Product integrity in the pharma and other basic markets, is a crucial factor to protect your brand and consumers.

Human health remains to be a risky business as there will always be discoveries of new illness. A bid to find curable solutions for rising illness spans from pharmaceutics, traditional medicine, homeopathic and herbal therapies.


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Pharmaceutical supply chains have grown exponentially over the past decade and will continue to do so not only to fulfil the demand of existing drugs but also to treat a new wave of genetics problems uncovered after the validation protocol of university hospitals and research facilities. There are however, more drugs (especially those closely related to biotechnology, such as vaccines and gene therapy) which imply another growing challenge, to ensure their pharma supply chains to the final patient.

Product integrity in the pharma

There are many issues already highlighted by global manufacturers on how to abide by a set of complex requirements proposed by the FDA, Ministry of Health and hospitals to secure and protect the products in the supply chain. These are emerging especially in many other markets such as food, beverage and cosmetics.


These requirements are divided in two major categories:

  • Securing the product from counterfeiting and diversion with the standard approach of full traceability with end to end transparency for the global supply chain.
  • Securing product integrity in terms of content and container such as leak detection, temperature control and other measurements throughout its lifecycle up to end-consumers, such as expiration period once opened.

Not only sensitive products such as cosmetics, food, beverage and drugs, have an expiration date. They also have a use by date once opened, which means that if surpassed, consuming or using the product may inflict health damage. It is understandable that many recalls are actually due to product microbial contamination from leakage or exceeded usage.

Drugs such as vaccines or injectable hormones must be conserved in a strict temperature range between 2 - 8°C and 15 - 25°C while traveling across the global supply chains. If this temperature is not preserved, it can lead to product adulteration and content damage. Product security, hereafter named, product integrity in the pharma and other basic markets is a very important factor to keep sustainable within your supply chain therefore protecting your brand and consumers.


On one side, you can protect product integrity against counterfeiting, diversion and adulteration through serialization & aggregation. On the other side, you can control and measure through CCIT technologies and sensors to ensure the right temperature or detect any leakage or cosmetic defects, not only within production but also within distribution and logistical warehouses for true end to end coverage.


In fact, the World Health Organization (WHO) declared that about 10% of drugs are counterfeited in developing countries however, Interpol mentioned that the number is much higher, at around 30% - following a study done by Deloitte about resilience and reinvention in a changing marketplace. It is also agreed by both on how regulatory compliance is mandatory to solve this major problem despite costing both time and money for implementation on each production line, up to warehouses and logistic distributions.


Product serialization means assigning a unique number to each saleable item, which is then linked at the case, pallet and batch number/ manufacture indirectly. This tactic has been developed by GS1 standardization body for example and can help verify genuine products produced by authorized manufacturers as listed on the item, as well as full traceability throughout its lifecycle therefore pinpointing exact events that may lead to product recall. This is the era of Smart Product where consumers and any player in the supply chain can easily scan its barcode/ QR code/ data matrix or RFID to get all the information needed about its original manufacturer and tracking steps, thus matching it with the reality to detect counterfeiting/ diversion. That’s why most of countries nowadays (Turkey, Russia, China, Japan, EU and USA, to name a few) are forcing their manufacturers to comply with Track & Trace regulations to secure their products.

 

There is another major requirement disrupting the pharma supply chains and that is the growing demand for total quality control inspection on all products with the requirement to control temperature during the distribution phase, as well as how to withdraw finished (expired drugs) or contaminated products. As we notice today, the worldwide expenditure for new biotechnology drugs such as those used for gene therapy and vaccines, is expected to greatly increase and these drugs require conservation of the temperature during distribution and storage to keep their integrity and save lives. They are classified as cold chain products.

 

In conclusion, manufacturers must protect their products from counterfeiting, diversion, adulteration and contamination by complying to the regulation authorities and implement traceability solutions combined with inspection tools to secure and sustain global supply chains, while minimizing recalls and saving lives. Welcome to the intelligent ecosystem (smart manufacturers) where products become digitalized or smart enough to help us in combatting recalls and mitigating risks.

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