DSCSA Serialization Its Not Too Late DSCSA. It stands for the Drug Supply Chain Security Act, but if youre a contract manufacturing organization CMO who has procrastinated, it means something along the lines of doomed, scared, cramming and scrambling around. DSCSA is the FDA regulation requiring pharma companies to begin serializing all prescription drug products intended for distribution to the U. S. market. That means printing each saleable unitthink carton, tray and individual bottlesand homogeneous shipper case with a unique identifier, starting Nov. Serialization is one of the first steps toward making every capsule, vial, tablet or strip traceable through the pharmaceutical supply chainfrom origin to destination, whether its the drug store or doctors office. Its the first stage of developing a system that will help regulators protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. A great many pharmaceutical manufacturers, CMOs and contract packaging organizations CPOs have re engineered their operations to comply with the regulation. Host Cannabis Economy Seth is an event moderator and has been hosting the Cannabis Economy podcast for nearly three years, chronicling personal conversations with. Xiphora Biopharma Consulting GlaxoSmithKline Introduction. This second article on genotoxic mutagenic impurities GTIs will focus on toxicological aspects and. No more missed important software updates UpdateStar 11 lets you stay up to date and secure with the software on your computer. From millions of real job salary data. Average salary is Detailed starting salary, median salary, pay scale, bonus data report. Graduate Program in Environmental Health Sciences formerly Environmental Toxicology Graduate Program UC Irvines Division of Occupational and Environmental Medicine. But as it was in high school, a few have not completed the homework, and theyre sweating bullets. A common question is, I havent started serializing, is it too late The answer depends on how you think about it. Theres a compliance perspective and a business perspective. Lets parse them out. From the legal perspective, what are the consequences of missing the deadline Will there be fines Sanctions Extensions No one but the FDA is qualified to answer, so lets set those questions aside for now. Now a question for you What is the business impact if your clients elect to avoid dealing with a contract manufacturer who is clearly missing the DSCSA deadline Potentially catastrophic, wed guess. Images/Larger%20than%20500px/Sarah_Methodology_2.png' alt='Derek Software Toxicology' title='Derek Software Toxicology' />Provides links to thousands of downloadable eBooks and online lectures, guides, and notes on science and medical topics. Derek Nexus is the expert, knowledgebased software that gives you accurate toxicity predictions quickly. Early, accurate in silico toxicity tests using Derek Nexus. So there really is no too late. If DSCSA applies to you and youre not on track, start now. In+Silico+Toxicology+1000%E5%80%8B%3A+DEREK%E7%AD%89%E3%81%AEin+silico%E3%83%84%E3%83%BC%E3%83%AB%E3%82%92%E7%94%A8%E3%81%84%E3%81%9F%E6%AF%92%E6%80%A7%E5%9B%9E%E9%81%BF+Super+Mutagen.jpg' alt='Derek Software Toxicology' title='Derek Software Toxicology' />The good news is that all is not lost. If you get started on your serialization implementation today and make a good faith effort, its reasonable to expect you can get a packaging line, perhaps more, fully serialized by the end of November. This article lays out a strategy for tackling the problem. Although you may be panicking, it doesnt include a panic stage. Thats not going to speed things up. First, lets admit DSCSA is complex and opaque and clarify exactly what the law requires that you, the contract manufacturer, complete by Nov. The requirements are probably less onerous than you think. There are two key items that need to be implemented by Nov. You need to apply unique serial numbers using 2. D barcodes to all saleable units e. Boom 1 7 Keygen Mac. You need to apply unique serial numbers using 2. D or linear barcodes to homogeneous cases. Note you do not have to aggregate yet. That is, your IT system doesnt have to know whats in the case and connect products in the case with the case number. These two requirements enable you, as a CMO, to verify the product within 2. Nov. 2. 7, 2. 01. Thats the law, but there might be some wiggle room here. Consider this provision Not until Nov. This implies that if theres non serialized inventory in the supply chain, with a date of manufacture prior to Nov. On the other hand, wholesalers will need a connection between the saleable unit and case level ID before very long to ensure theyre complying with the law. Now lets return the original question. If you havent started your serialization program, are you behind the eight ball Yes. Is it a crisis Hard to tell. Now that you understand the law, just get started. To get started, first commission a fast track serialization team. Assign members of your operation who are involved in business strategy, finance, labeling, operations, manufacturing, engineering, IT infrastructure, regulatory affairs, sales, marketing and supply chain management. Give them a clear mission statement Do what needs to be done to preserve our business, meet the regulatory requirements at the very least, do so efficiently, and, if possible, set ourselves up for new capacity and quality down the road. Again the prevailing question is, is it too lateNow that you know the law and whos in charge of getting you to compliancethe Fast Track Serialization Teamwe further refine the question. Too late for what and in whose viewTo answer, go over your internal business considerations around DCSCA compliance. Your goal is to better grasp what you need to do next and how fast. For example, if youre a CMO, whether youre late or not really depends on what your clients need from you in terms of serialization and when they need it. More on that in a minute. Another concern is your companys investment philosophy. How exactly are you profiting by scrambling to service the customers for whom serialization is the most important The answer will determine where and how you prioritize upgrades and reengineering. Then there are distributor requests. What are they asking of you Distributors have a requirement for 2. Finally, what are your own infrastructure capabilities for getting this done In other words, how hard is this going to be And is fast tracking serialization worth the extra cost and headaches Absolutely, if you decide its important to remain in the business of manufacturing prescription drugs. Drilling these questions in your mind should be helping you bring your challenge into crisper focus. But youre still not done with your problem statement. As mentioned above, you need to have one more set of conversations to get further insight. You need to speak directly with your clients about some practical implications of DSCSA. First, ask them directly Do they need to aggregate, or would serialization alone be enough for the time being As mentioned in above, youre not technically required to aggregate by the Nov. That is, you dont need labels on cases and pallets to know what serial numbers are inside them. But your customers might want you to be able to do that now. So ask, Can we live with just serializing to start Then again, if you have the resources and wherewithal, maybe you should go ahead and include aggregation in your project now. Data management is another key discussion point you need to take up with your clients. Does the customer want you to serialize and manage all the data for those products, packages and other saleable units Or do they just want to see the numbers Or do they want a lot of sophistication, e. Another question Does your customer want to give you the numbers that youll be applying to the product, or does the customer want you to generate the numbers yourself How will they need to exchange that information So as you can see, the question if its too late is largely a semantic one. Whether youre ready or not for the Nov. DSCSA deadline triggers the question, what does ready mean to you and your clients Fortunately, that hard question has a simple, familiar answer Just start now and dive in. With these conversations settled, you should be able to plunge into the work with confidence. Ultimately, youll need master planning, system integration and new technology implementation. If you need help, serialization consultants are available who can transform a production line or two between today and Nov. As you choose a vendor, make them prove they can save you money over competitors, execute faster, and minimize your downtime. Most CMOs hire a consulting partner and serialization vendors after initiating their project internally. Whether you do that and whenever you do that, the initial stages of a systematic project should look something like the following Scope definition. Formalize the scope of your project based on the early work of the Fast Track Serialization Team and conversations youve had to date. Define in writing the program requirements in terms of how many lines youll be transforming, the clients youll be exchanging data with, the labeling scheme you have in mind, and the warehouse flows. Level 4 scope definition.