TydenBrooks Secures Pharma Supply Chains

 

The pharmaceutical industry, much like the healthcare industry, has unique challenges that must be overcome to assure secure supply chains and protect the bottom line. TydenBrooks has worked with many key players in the industry and developed strategies and products to help with these. Visibility, logistics coordination, compliance with laws and regulations, and cold-chain shipping are some of the main issues that are present in the pharmaceutical industry. Securing these areas helps not only protect the manufacturers and distributors but the healthcare providers and consumer as well.

 

Visibility

 

While theft and pilferage are serious problems in the pharmaceutical industry, counterfeit drugs, product damage, drug shortages, and disposal of out of date products are other issues that fall under visibility challenges. Many hard-hitting headlines that are critiquing the industry today highlight how patients, regulators, and retailers alike do not often know where drugs are coming from and their creation process. 

 

The global pharmaceutical industry strives to solve these visibility problems by attaching product identifiers to every product and creating a system everyone in the industry can access. Achieving this goal to solve visibility problems would not only help track and trace for the consumers' sake, but also may boost margins and result in safer products.

 

Seemingly simple mistakes can quickly become error rates in studies, shortages in hospitals, and have other serious consequences. With improved visibility along the supply chain, which is where TydenBrooks products such as the GeoBolt™ come into play, problems that occur can be pinpointed, investigated and addressed.

 

Logistics Coordination

 

There are a variety of systems and processes used by different supply chains that are providing pharmaceutical products to healthcare providers around the world. This variety can make it hard to keep track of and meet each buyers' requirements.

 

For example, an emerging treatment known as CAR-T cell therapy is a form of immunotherapy that uses specially altered T-cells to fight cancer. Some hospitals may require that the products get to the hospital before they start the procedure, while others may start the procedure with minimal product and rely on just-in-time delivery. Differences in these variances in processes span across the industry and make standards or quality control challenging to implement.

 

 

 

 

 

Compliance

 

Roughly 80% of active pharmaceutical ingredients and 40% of the finished drug product are shipped into the U.S. from overseas. A key source of generic drugs prescribed to Americans are manufacturers in India and China.

 

In the U.S., the Food and Drug Administration is tasked with ensuring facilities based in foreign countries remain in compliance with Good Manufacturing Practices, a standard for aseptic production of pharmaceuticals.

 

Recently, inspectors from the FDA have issued warning letters to manufacturers abroad at increasing rates, putting quality and compliance in focus as these industries in China and India look to move up the value chain into new drug development.

 

It is not only manufacturing that must meet these requirements. Shippers and distributors will soon have to comply with regulations under the Drug Supply Chain Security Act, which requires any company wishing to sell pharmaceuticals in the U.S. to facilitate product "traceability" by 2023. Meeting these new regulations will require significant changes and investment through the supply chain.

 

Cold-chain Shipping

 

Many of the world's top-selling medicines are of biologic origin, and the number is increasing. While all drugs are sensitive to the rigors of cross-border shipping, biologics, in particular, are heat sensitive and susceptible to contamination.

 

Keeping these drugs cold is a crucial part of the supply chains that connect medications to patients. Cold-chain shipping will begin to take an even greater role as more and more cell, and gene therapies progress through clinical testing and onto markets worldwide.

 

In addition to these medications needing to remain very cold, many of these treatments and medications are personalized to each patient. Therefore, track and trace capabilities become even more crucial for implementing software that can maintain a detailed chain of identity and custody.

 

The TydenBrooks Solution

 

Many of our products help secure and track shipments along the supply chain, and many of our new technology seals allow for even more in-depth and accurate track and trace capabilities.

 

The best option for ultimate track and trace security is our new GeoBolt™ seal. The GeoBolt™ is a reusable, state-of-the-art tracking device that combines visual tamper evidence, monitors location and offers real-time alerts to cargo owners, when and where tampering occurs. This device uses a high-security ISO 77772: 2073 compliant bolt seal integrated with GeoSmart and can detect anomalies in the supply chain 24/7.

 

In addition to the GeoBolt™, our line of RFID seals can both secure and provide the option of storing information, such as patient information or product information, which will become available upon scanning with a reader. This feature allows for fast and accurate inventory as well as making sure the right medications and treatments arrive at the right locations. These seals also come in our high-security bolt and cable seals or as plastic tamper-evident seals as well.

 

With the GeoBolt™ and RFID being the best options for track and trace, storing information, and security; our reliable catalog also offers several high-security options to combine to form a multilayered security strategy that will protect every aspect of the supply chain. Our high-security SeaLock barrier seal is unique in that it requires two cuts and protects keyper bars for all modes of transport, including cross-border and international shipments.

 

Other high-security seals such as the FS50 and SnapTracker also provide ISO certified security and can be combined with our tamper-evident plastic seals (All Seal, Equilok, and Plastic Padlocks) and our security Tapes and Labels to increase protection and tamper evidence. Many of these offer marking options such as 1D, 2D, and QR Code.  

 

Protection and Security

 

These products and strategies go a long way in protecting the public which in turn protects a company’s brand reputation and increases their value. TydenBrooks solutions also improve a company’s bottom line by preventing loss and damaged product claims. These solutions help protect and streamline process that will ultimately also improve on-time deliveries to wholesalers, distributors, hospitals, and patients.

 

In the end, hospitals and healthcare providers need to be able to rely on these medicines and treatments arriving on-time and uncontaminated. They need the right products going to the right place, and in many cases, it is even life or death, so making sure the supply chain is secured, and dependable is very important for everyone involved.

 

For more information or to discuss your unique security needs and challenges, contact TydenBrooks at 1-800-458-SEAL or via email at info@tydenbrooks.com. We look forward to helping you prevent theft, pilferage, and tampering while ensuring the secure movement of finished goods and raw materials by your company and partners.

The pharmaceutical industry, much like the healthcare industry, has unique challenges that must be overcome to assure secure supply chains and protect the bottom line. TydenBrooks has worked with many key players in the industry and developed strategies and products to help with these. Visibility, logistics coordination, compliance with laws and regulations, and cold-chain shipping are some of the main issues that are present in the pharmaceutical industry. Securing these areas helps not only protect the manufacturers and distributors but the healthcare providers and consumer as well.

Visibility

While theft and pilferage are serious problems in the pharmaceutical industry, counterfeit drugs, product damage, drug shortages, and disposal of out of date products are other issues that fall under visibility challenges. Many hard-hitting headlines that are critiquing the industry today highlight how patients, regulators, and retailers alike do not often know where drugs are coming from and their creation process.

The global pharmaceutical industry strives to solve these visibility problems by attaching product identifiers to every product and creating a system everyone in the industry can access. Achieving this goal to solve visibility problems would not only help track and trace for the consumers' sake, but also may boost margins and result in safer products.

Seemingly simple mistakes can quickly become error rates in studies, shortages in hospitals, and have other serious consequences. With improved visibility along the supply chain, which is where TydenBrooks products such as the GeoBolt™ come into play, problems that occur can be pinpointed, investigated and addressed.

Logistics Coordination

There are a variety of systems and processes used by different supply chains that are providing pharmaceutical products to healthcare providers around the world. This variety can make it hard to keep track of and meet each buyers' requirements.

For example, an emerging treatment known as CAR-T cell therapy is a form of immunotherapy that uses specially altered T-cells to fight cancer. Some hospitals may require that the products get to the hospital before they start the procedure, while others may start the procedure with minimal product and rely on just-in-time delivery. Differences in these variances in processes span across the industry and make standards or quality control challenging to implement.

Compliance

Roughly 80% of active pharmaceutical ingredients and 40% of the finished drug product are shipped into the U.S. from overseas. A key source of generic drugs prescribed to Americans are manufacturers in India and China.

In the U.S., the Food and Drug Administration is tasked with ensuring facilities based in foreign countries remain in compliance with Good Manufacturing Practices, a standard for aseptic production of pharmaceuticals.

Recently, inspectors from the FDA have issued warning letters to manufacturers abroad at increasing rates, putting quality and compliance in focus as these industries in China and India look to move up the value chain into new drug development.

It is not only manufacturing that must meet these requirements. Shippers and distributors will soon have to comply with regulations under the Drug Supply Chain Security Act, which requires any company wishing to sell pharmaceuticals in the U.S. to facilitate product "traceability" by 2023. Meeting these new regulations will require significant changes and investment through the supply chain.

Cold-chain Shipping

Many of the world's top-selling medicines are of biologic origin, and the number is increasing. While all drugs are sensitive to the rigors of cross-border shipping, biologics, in particular, are heat sensitive and susceptible to contamination.

Keeping these drugs cold is a crucial part of the supply chains that connect medications to patients. Cold-chain shipping will begin to take an even greater role as more and more cell, and gene therapies progress through clinical testing and onto markets worldwide.

In addition to these medications needing to remain very cold, many of these treatments and medications are personalized to each patient. Therefore, track and trace capabilities become even more crucial for implementing software that can maintain a detailed chain of identity and custody.

The TydenBrooks Solution

Many of our products help secure and track shipments along the supply chain, and many of our new technology seals allow for even more in-depth and accurate track and trace capabilities.

The best option for ultimate track and trace security is our new GeoBolt™ seal. The GeoBolt™ is a reusable, state-of-the-art tracking device that combines visual tamper evidence, monitors location and offers real-time alerts to cargo owners, when and where tampering occurs. This device uses a high-security ISO 77772: 2073 compliant bolt seal integrated with GeoSmart and can detect anomalies in the supply chain 24/7.

In addition to the GeoBolt™, our line of RFID seals can both secure and provide the option of storing information, such as patient information or product information, which will become available upon scanning with a reader. This feature allows for fast and accurate inventory as well as making sure the right medications and treatments arrive at the right locations. These seals also come in our high-security bolt and cable seals or as plastic tamper-evident seals as well.

With the GeoBolt™ and RFID being the best options for track and trace, storing information, and security; our reliable catalog also offers several high-security options to combine to form a multilayered security strategy that will protect every aspect of the supply chain. Our high-security SeaLock barrier seal is unique in that it requires two cuts and protects keyper bars for all modes of transport, including cross-border and international shipments.

Other high-security seals such as the FS50 and SnapTracker also provide ISO certified security and can be combined with our tamper-evident plastic seals (All Seal, Equilok, and Plastic Padlocks) and our security Tapes and Labels to increase protection and tamper evidence. Many of these offer marking options such as 1D, 2D, and QR Code.

Protection and Security

These products and strategies go a long way in protecting the public which in turn protects a company’s brand reputation and increases their value. TydenBrooks solutions also improve a company’s bottom line by preventing loss and damaged product claims. These solutions help protect and streamline process that will ultimately also improve on-time deliveries to wholesalers, distributors, hospitals, and patients.

In the end, hospitals and healthcare providers need to be able to rely on these medicines and treatments arriving on-time and uncontaminated. They need the right products going to the right place, and in many cases, it is even life or death, so making sure the supply chain is secured, and dependable is very important for everyone involved.

For more information or to discuss your unique security needs and challenges, contact TydenBrooks at 1-800-458-SEAL or via email at info@tydenbrooks.com. We look forward to helping you prevent theft, pilferage, and tampering while ensuring the secure movement of finished goods and raw materials by your company and partners.