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When a pharmaceutical supply chain is compromised, there can be disastrous consequences, not only for consumers, but also for manufacturers. Without comprehensive security measures, pharmaceuticals are susceptible to counterfeit, diversion, dilution, tampering and deliberate contamination ultimately compromising patient safety.
Ensuring the safety and reliability of the bio/pharmaceutical supply chain has become a crucial component of manufacturing operations in an increasingly complex sourcing environment. Suppliers are the critical link in the supply chain so manufacturers should take certain steps to collaborate with them to ensure supply chain security.
In addition to collaborating closely with suppliers, manufacturers who understand the origin and flow of materials during the lifecycle of the supply chain can help reduce risk for the consumer. Additionally, developing and implementing supply management procedures, protecting the product from tampering and keeping a transparent record of the product at all times help fulfill federal oversight obligations while maintaining quality and confidentiality.
The capability of the manufacturing processes to provide consistent quality and service is dependent on the reliability of the suppliers. Manufacturers who collaborate with suppliers and apply total quality, lean and agile manufacturing, and statistical tools, drive continuous supply chain security improvement.
Security starts with your supplier
Consider enlisting a third-party consultant to conduct comprehensive analysis to ensure the supplier will meet performance goals and quality requirements. Overall, the supplier should be a robust and financially sound company, with ethical and legal business practices and a deep understanding of good manufacturing practice (GMP) requirements. The supplier should also have a reliable management of change (MOC) process, which shows that the supplier regularly evaluates changes in facilities, documentation, personnel and operations to ensure that any safety, health and environmental risks that may result from changes are tightly controlled. With a thorough MOC process on record, you can be sure that the supplier is committed to providing reliable, consistent high-quality products in a safe manner. Any significant changes implemented by the supplier should be sent to you in writing.
Before you make a final decision on a supplier, conduct an on-site audit. The supplier should have a reliable and stable method of manufacturing products with statistical process controls in place. The supplier’s products should be delivered on time, in secure packaging and accompanied with a certificate of analysis. Be sure to obtain several lot samples - from the end product, not the bulk containers - to determine the quality of the final product.
When you have chosen a supplier, obtain supplier quality agreements that list the products and services that are covered under your contract with the supplier. You could have multiple quality agreements with the same supplier, depending on how many products the company is manufacturing for your business. Make sure to specify if the facility should have ISO certification, and clearly state any product requirements, such as purity and overall performance.
After you have chosen your suppliers, constantly evaluate their performance over the course of your business relationship. One of the best ways to determine a supplier’s performance is the use of a supplier scorecard, which can contain categories that are based on federal guidelines. Supplier scorecards are a great way to collect statistical data in important categories such as product quality, customer service and overall cost. The results of the scorecards can be the basis for overall risk assessment of the supplier.
Another way to ensure that your suppliers are fulfilling the correct manufacturing procedures and processes is to conduct on-site audits, which can identify if there are changes in the manufacturing process that affects the quality of the product. If something out of the ordinary is found, the supplier should quickly prepare and plan to correct what is wrong, determine what caused it and implement corrective action. A follow-up audit can determine if everything is resolved to your company’s satisfaction.
If audits cannot be conducted by a third party, implement a comprehensive training program so your auditing staff gains experience with a variety of suppliers and knows what to look for during the visit, and how to understand and analyze all of the documentation that accompanies an audit.
Implement the Strongest Physical Security Measures for Your Products
As the pharmaceutical supply chain has expanded across the globe, transportation of GMP products - and ensuring their safety - is becoming increasingly complex. During transportation, products are especially susceptible to dilution and tampering. By working closely with your supplier, you can implement controls to ensure that products are securely transported to your company’s facility. Before the products are loaded onto the truck, send an advance shipping notice, which is an electronic document similar to a packing list that notifies the manufacturer of an impending delivery.
The products should be placed in locked, tamper-evident packaging, including tamper-proof seal numbers, on bulk casing, preferably with bar codes that can be scanned when the products arrive. Images of the containers, closure systems and the labeling should be kept in an electronic library so that when the products reach their destination, they can be checked to ensure that the containers, closure systems and labeling are still intact and the containers are the same as those that were expected to arrive.
Limit your transportation vendors and choose reliable partners. When transporting product, dedicated, point-to-point shipments introduce less risk than truck-load alternatives, which may require consolidation. With dedicated trucks, seals can be checked upon arrival to verify the shipment was not opened. For further security, there are many other process and system tools available including surveillance, tightly scheduled truck routings, tracking devices and temperature-time tracking.
When the product has arrived, receiving staff should verify that the locks, labeling and product packaging are not broken or ripped. A barcode scan can also reveal that the products have not been swapped out for counterfeit packages along the journey.
Technology to ensure transparency
Using technology to track all transactional activities within the supply chain and the flow of product throughout the chain allows for better product traceability. Consider software to electronically store all information from supplier audits, including audit plans, checklists, supplier communications and closure letters. There are software programs available that are compliant with 21 CFR Part 11, ensuring your supplier and your business are fulfilling documentation responsibilities mandated by the U.S. FDA. In the European Union, the comparable legislation is set out in Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999, concerning a European Community framework for electronic signatures.
Many documents are used to track GMP products throughout all aspects of the supply chain. These documents can be sent to suppliers, manufacturers and other vendors through a secure electronic data exchange. One of the benefits of electronic documents is that there is less chance for counterfeit alterations that can occur with photocopied paper documents. And because of advances in technology and cloud computing, the documents can be updated and reviewed in real time by multiple suppliers and manufacturers alike.
To help protect consumers from contaminated medicine or counterfeit drugs, the U.S. FDA requires a pedigree, or documentation containing the lot, potency, manufacturer, distributor and unique identifier of the salable unit. As the product moves down the supply chain, the pedigree information is reviewed and updated. Then, at the final point of sale, the product’s entire journey through the supply chain is documented. This important information can be rendered into an electronic document that can be sent securely via an electronic data exchange.
On July 1, 2011, the Official Journal of the European Union published Directive 2011/62/EU, amending Directive 2001/83/EC and finalizing the text of the so-called “Falsified Medicines Directive.” In general, by January of 2013, this directive is to be adopted into the national laws of EU member states. Though some of the aspects of this legislation still need to be developed, the direction the EU is taking is consistent with regulatory agency proposals to adopt stronger supply chain controls for drug products.
Collaboration is key
Suppliers must meet your expectations; common metrics to measure success include the quality of the product, response to corrective actions, on-time delivery, compliance with regulations and invoice accuracy. To help encourage suppliers and build a strong rapport, consider implementing an awards program to honor and recognize suppliers who consistently exceed your business’ expectations for performance, cooperation and collaboration. Evaluate the suppliers on a regular basis and use statistics derived from those metrics to determine which suppliers should be named in the program.
A secure supply chain leads to open communication, problem prevention, constructive feedback and increased profits- but most importantly, it results in consistent and reliable products that are safe and improve the lives of patients.