Safety is a huge challenge for pharmaceutical manufacturers.
It covers several aspects, from patient and customer safety to supply chain, manufacturing and packaging security.
To meet the challenge, traceability provides valuable investigation tools to monitor environmental conditions along the supply chain, improve quality control and limit returns.
Within an ever-changing industry facing a constantly evolving regulatory landscape, the manufacturing of drugs has drastically changed.
OPTEL has developed automated vision inspection to inspect 100% of the drug production for pharmaceutical manufacturers and CMOs.
The actors within the pharma-industry ecosystem have developed several tools to insure packaging and labeling safety, such as custom package seals and tamper-evidence features, to verify whether the enclosed drugs are what the package says they are. These include authentication labels, holograms, security printing and Track&Trace systems. These elements can be valuable parts of an overall security system.
OPTEL has developed automated vision inspection and traceability solutions that can meet any regulatory compliance standards for both packaging and labeling for pharmaceutical manufacturers, contract manufacturers and contract packagers.
The solutions also help reduce the costs related to recalls due to labeling mix-up, incorrect or missing expiration date, and false or misleading labeling.
The pharmaceutical market is a global ecosystem with several actors, including pharmaceutical manufacturers, CMOs, CPOs, virtual manufacturers, repackagers, parallel importers, wholesalers and distribution centers, 3PL, hospitals and pharmacies.
Products cross borders as they are imported or exported. They are shipped, and may be unpacked and repacked, labeled, serialized and aggregated. This all depends on territory regulations that vary from one region to another. For example, in the U.S., the FDA will require aggregation compliance by 2023, while in Europe, the EU FMD only requires sellable units to be serialized for now; and ANVISA in Brazil will require sellable unit serialization and aggregation by 2022.
All these operations and stakeholders contribute to increased risks in the supply chain. Track&Trace solutions are key tools to improve the safety of the supply chain in an increasingly complex market.
From tracking the origin of the active pharmaceutical ingredients (API), to the manufacturing, packaging and transportation of the distribution-ready medicines, the pharmaceutical supply chain needs to be secured to guarantee that the products are authentic and safe for the patient. To protect consumers, regulators have responded to the counterfeit-drug problem by enforcing higher standards of transparency and traceability throughout the pharmaceutical supply chain.
Traceability is the tracking all of the components through the movement, storage, distribution, recall, return and temperature control (cold chain) processes.
One of the major threats to patient safety is counterfeiting. Counterfeited medicines put patients’ health at risk. In some cases, they can result in death.
According to industry estimates, counterfeit pharmaceuticals are the most lucrative sector of the global trade in illegally copied goods.
A 2018 Fraser Institute study notes that every type of drug can be counterfeited: branded drugs, generic drugs, over-the-counter drugs and even herbal remedies. These counterfeit medicines may contain no active ingredient, harmful ingredients, the wrong drug, the wrong concentration or dose, or be past their expiry dates.
Pharmaceutical counterfeiting spans every continent, and no medicine is immune. This issue is taken very seriously by governmental organizations, who implement regulations and tools such as anticounterfeiting platforms to fight the problem.
Counterfeited medicines are illegal and may be harmful to your health.
OPTEL has developed automated vision inspection and traceability solutions to help improve patient safety, from the raw materials to the dispensing or administration point in hospitals or pharmacies.