Drug traceability function will realize whether the supply chain of pharmaceutical enterprises can meet the requirements

[China Pharmaceutical network industry trends] the core concept behind the US Drug Supply Chain Security Act is to develop and maintain a tracking system from drug production to sales terminals, and to ensure 100% accuracy If the drug needs to be listed in the United States, the drug companies must complete the relevant guidelines for the sequence, validation, data exchange and storage of the entire drug before the post November deadline of that year (the drug traceability function will enable the supply chain of pharmaceutical companies to meet the requirements Photo source: Baidu photo) for those American drug manufacturers who focus on the production of late clinical trial drug products and are waiting for the approval of the food and drug administration, an important issue may be ignored: preparing for drug serialization Since November last year, all pharmaceutical companies selling prescription drugs in the U.S market have had to serialize on every single drug available for sale More specifically, if your drug does not comply with the United States Drug Supply Chain Security Act (dscsa), and there is no national drug code (NDC), serial number, batch number, and expiration date, then the transportation of these controlled drugs will be strictly prohibited, which is to protect the drug supply chain from counterfeit drugs When the FDA approved the drug (or authorized treatment drug), no company in the late clinical trial stage wanted to be considered illegal or non-compliance There is no doubt that these pharmaceutical companies need to understand the compliance of the drug supply chain, so how can they meet the requirements of the serialization rules? This article will elaborate some basic points of the drug supply chain safety act of the United States, and provide four methods for drug manufacturers to ensure that they can reduce the risk to a large extent after the "green light" of the food and Drug Administration of the United States And maintain its profit momentum How do drug manufacturers meet regulatory compliance requirements? The core concept behind the US drug supply chain safety act is to develop and maintain a tracking system from drug production to sales terminals, and to ensure 100% accuracy For pharmaceutical companies in phase III clinical trials, the US Drug Supply Chain Security Act will not impose any restrictions on them However, once the drug is to be listed in the United States, pharmaceutical companies must complete the relevant guidelines for drug sequence, validation, data exchange and storage before the post November deadline of that year The specific methods are as follows: 1 Use 2D DataMatrix QR code to realize serialization in drug packaging stage; use 2D DataMatrix or linear barcode to realize serialization in drug uniform sealing condition stage; set relevant data to be readable by machine or human, including national drug code (NDC), serial number, batch number and effective period 2: data exchange and storage provide trading data to trading partners only in electronic form Transaction data set includes transaction information (TI), transaction history (th) and transaction statement (TS), referred to as T3 The drug serialization data must be stored in an active and easily accessible place and must be kept for at least six years, subject to the transaction date 3: the inspection shall be carried out within 24 hours upon the request of authorized drug wholesalers, secondary packagers and / or distributors; the commodity identification of drug products shall be inspected at the level of marketing ; check the commodity identification of returned drugs to prevent resale When it comes to planning drug serialization, pharmaceutical companies should not delay If pharmaceutical companies can't serialize drugs, they won't be able to bring their products to market Any pharmaceutical company, after investing a lot of time and money in drug research and development, needs to complete the latter thing, which is to meet the requirements of the drug supply chain safety act of the United States If you can pay attention to the following four points, you may be able to pave the way for your drugs to reach the U.S market: 1 Identify partners and open up communication channels Many pharmaceutical companies in phase III clinical trials are actively seeking external partners and have completed product processing, packaging and transportation Nowadays, contract processing outsourcers and third-party logistics service providers play a very important role in the manufacturing process of commercial products, and also play a huge role However, all of these partners need to exchange serialized data as required by the US Drug Supply Chain Security Act Even if it only cooperates with a contract processing outsourcer to provide large-scale processing and packaging services for drugs, or only cooperates with a third-party logistics service provider to help it deliver serialized drugs to customers, the pharmaceutical company must also consider how to conduct data exchange Therefore, for any pharmaceutical company in phase III clinical trials, the earlier the dialogue with partners, the better, so as to determine a unified and feasible system in advance Moreover, without cooperation with contract processing outsourcers and third-party logistics service providers, it is difficult for drug manufacturers to put their products on the market 2 Understand how drug serialization affects operation When the drug manufacturer has printed the date code on each drug product sold, but the serialization function is not only to print and label information The serialization and management of pharmaceutical products will continue to affect the compliance of every aspect of the company, including processing, information technology, quality assurance, supply planning, and regulatory operation Those enterprises that complete internal production and drug packaging, or even more complex serialization integration, need to face more difficulties However, whether it is completed within the enterprise or outsourced, it will have a different impact on the operation of the enterprise 3 It is very important for pharmaceutical companies to understand the correct serialization solution Drug serialization is a "beast", which can affect all aspects of pharmaceutical companies' operation, also bring challenges to data exchange and storage, and even affect the downstream of the industry So an important decision for pharmaceutical companies is to find the right serialization infrastructure solution Simply put, if the solution is chosen well, the operational risk of the enterprise can be reduced to a large extent But the question is, what kind of business model is this? For companies just entering the pharmaceutical industry, we can learn from the (relatively mature) regulatory requirements of life science, or use some industry standards such as EPCIS However, you must also be flexible enough to adapt to some non-standard regulatory requirements and avoid increasing costs due to some specific industry regulations In addition, you can also connect with contract processing outsourcers, third-party logistics service providers and wholesalers (which may have completely independent requirements and standards) as early as possible to achieve interoperability, pave the way for the completion of drug serialization, and promote the growth of success 4 Accept serialization preparation, which may take longer than expected If a drug is not serialized when FDA Approves it, it may take weeks and months for a pharmaceutical company to prepare for the serialization Around this point, the sooner a pharmaceutical company is ready to develop a serialization strategy, the better, because you have to discuss with potential partners and explore appropriate serialization infrastructure solutions Even if you don't have a drug ready to go on the market by November of this year, it's wise to prepare in advance and take precautions In fact, many pharmaceutical companies are doing it now Recently, tracelin NK webinar conducted a drug serialization survey called "dscsa journey: a day in the life of a serial number" The results show that nine of the 10 pharmaceutical companies currently in the third stage of drug trials are studying, designing or actively deploying drug serialization strategies Because they understand that once the FDA Approves the resolution, they must comply immediately, otherwise their drug products will not be put on the market The promulgation of the American drug supply chain safety act has stimulated the new market of drug tracking and Traceability Technology, and may also bring new profit points to enterprises in the drug supply chain Even pharmaceutical companies that have not yet launched their pharmaceutical products to the market will not be too late to launch the strategy of drug serialization.