Ingredients, materials, physical environment, storage containers and conditions, transportation and handlers are the biggest concerns, before the concept of counterfeiting is even taken into consideration.
One recall can destroy a company image long term, submitted by one end user in one digital click. It is estimated from iso.org that on average it can cost any single company up tu $10 million to recall a product and approximately 87% of people will buy from companies that can manage the risks associated with recalls.
So, how to keep your company out of the recall blacklist? Consider supply chains are the first to blame and every aspect needs to be analyzed in order to address the source of the problem.
It is obvious to start by:
- implementing the quality standards about product recall and safety such as ISO 10393 and ISO 10377,
- comply to reguations, especially for pharmaceutics and food safety, as well as adopt good practices such as Good Hygiene Practices (GHP), HACCP (Hazard Analysis and Critical Control Points) and Good Manufacturing Practices (GMP) while
- pursuing routine tests and verifications in order to mantain continuous product safety for end consumer.
But this quality validation process is still not enough, because recalls will happen even with the best quality and safety practices in place due to contamination or precautionary measures as mentioned before.
This concept is now easier to control thanks to the digital twin ecosystem where transparency is paramount in the connected supply chains and product information is accessible at any point. Traceability is helpful to track a product through its lifecycle (using a transparent label). It is on the right track but still only one step closer and does not ensure pinpointed recall analysis to determine where and when the problem occurred as the issue is not only related to the tracking process.
In fact, a complementary strategy is needed to encompass Inspection in order to reduce, if not avoid completely, product recalls and safety violation. In recent years, there is a well- known trend towards automated inspection machines in pharmaceuticals. Fully automatic inspection machines are leveraging many technologies for visual inspection, in order to detect leakage, foreign bodies and cosmetic defects. We can cite Artificial Intelligence and machine learning techniques, X-Ray and NIR technologies, as well as Container Closure Integrity Testing (CCIT) for prioritizing non-destructive deterministic methods. CCIT is considered a regulatory requirement by FDA and USP as it controls sterile and safe products by preventing leakage thus reducing contamination and loss of drug quality.
A sustainable supply chain is based on three main pillars such as visibility, traceability and quality inspection control in order to minimize the effects of product recalls and ensure patient safety worldwide.
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